Import Alert 66-40 from FDA--Red List of Foreign Processors: "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"; (2024)

Alert is found here.

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 66-40

Published Date: 07/26/2012

Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"

Reason for Alert:

*** Foreign inspections of pharmaceutical manufacturers are being performed. Detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).

Detention without physical examination may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA concludes reveals conditions or practices warranting detention of either particular products or all products manufactured by a firm.

DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the responsible FDA Center. ***

Guidance:

*** Districts may detain, without physical sampling and analysis, the indicated drug products from the foreign processors noted in the Red List of this import alert.

Foreign processors listed on the Red List of this import alert who would like to request removal from that list should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by documentation. For guidance on removal from detention without physical examination, refer to FDA�s Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)." Information supporting removal should be sent to CDER's Office of Compliance, (HFD-300). ***

Product Description:

Various drugs (See attachment)

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control of pharmaceutical products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B)."

OASIS Charge Code: DRUG GMPS


AUSTRALIA

Radpharm Scientific

Date Published : 09/10/2009

57 Oatley Court , Belconnen, AUSTRALIA

66 V I P 99 Miscellaneous Patent Medicines, Etc.

Date Published: 09/10/2009

Notes:Nexavir


BELGIUM

Qualiphar Nv

Date Published : 01/18/2011

Rijksweg 9 , Bornem, BELGIUM

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 01/18/2011

Notes:All drug products

60 - - - -- Human and Animal Drugs

Date Published: 01/18/2011

Notes:All drug products

61 - - - -- Human and Animal Drugs

Date Published: 01/18/2011

Notes:All drug products

62 - - - -- Human and Animal Drugs

Date Published: 01/18/2011

Notes:All drug products

63 - - - -- Human and Animal Drugs

Date Published: 01/18/2011

Notes:All drug products

64 - - - -- Human and Animal Drugs

Date Published: 01/18/2011

Notes:All drug products

65 - - - -- Human and Animal Drugs

Date Published: 01/18/2011

Notes:All drug products

66 - - - -- Human and Animal Drugs

Date Published: 01/18/2011

Notes:All drug products


CANADA

Aleeda Inc

Date Published : 05/29/2012

7115 Tomken Rd , , Mississauga, ON CANADA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 05/29/2012


60 - - - -- Human and Animal Drugs

Date Published: 05/29/2012


61 - - - -- Human and Animal Drugs

Date Published: 05/29/2012


62 - - - -- Human and Animal Drugs

Date Published: 05/29/2012


63 - - - -- Human and Animal Drugs

Date Published: 05/29/2012


64 - - - -- Human and Animal Drugs

Date Published: 05/29/2012


65 - - - -- Human and Animal Drugs

Date Published: 05/29/2012


66 - - - -- Human and Animal Drugs

Date Published: 05/29/2012

Macco Organiques

Date Published : 01/13/2011

100, Rue Mcarthur , Salaberry-de-valleyfield, Quebec CANADA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 01/13/2011

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products


Pax-All Manufacturing Inc

Date Published : 02/23/2012

7115 Tomken Road , Mississauga, ON CANADA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 02/23/2012

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products


CHINA

BOAI NEW KAIYUAN PHARMACY CO.,LTD.

Date Published : 09/17/2010

No.9 ZhongShan Road , Boai City , Jiaosuo, CN-41 CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/17/2010

Notes:All drug products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/17/2010

Notes:All drug products

60 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

61 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

62 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

63 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

64 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

65 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

66 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products


BOAI NKY PHARMACEUTICALS LTD.

Date Published : 09/17/2010

Suites 1808-9 Guohua Building, 857 Dagu- , Nan Road, Hexi , Tianjin,China , tianjin, CN-12 CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/17/2010

Notes:All drug products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/17/2010

Notes:All drug products

60 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

61 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

62 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

63 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

64 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

65 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

66 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products


Bluetech Chemicals Limited

Date Published : 09/17/2010

Rm 703, No. 25, Lane 175 , Shanghai, CN-31 CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/17/2010

Notes:All drug products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/17/2010

Notes:All drug products

60 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

61 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

62 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

63 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

64 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

65 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

66 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products


Boai Xinda Food Co., Ltd.

Date Published : 09/17/2010

The North Of Dong Wang He, Xiaojing , Boai, CN-41 CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/17/2010

Notes:All drug products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/17/2010

Notes:All drug products

60 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

61 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

62 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

63 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

64 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

65 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

66 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products


Changzhou SPL Company, Ltd.

Date Published : 09/10/2009

3 Changhong West Rd., , Hutang Township, Wujin City , Changzhou, Jiangsu Province CHINA

55 R - - 75 Crude Heparin (Pharmaceutic Necessity)

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

55 R - - 99 Pharmaceutic Necessities, N.E.C.

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

57 D - - 38 Whole Blood (Human) Heparin (Blood and Blood Derivatives)

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

61 L - - 08 Heparin Sodium (Anti-Coagulant)

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

61 L - - 22 Anti-Coagulant Heparin Sol

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

61 L - - 30 Heparin Calcium (Anti-Coagulant)

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

74 L - - IS Heparin Coating Chemicals

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

80 N - - ZW Heparin Vascular access flush

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

81 J - - BR Test, Heparin Neutralization

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

81 J - - OX Analyzer, Heparin, Automated

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

81 K - - FF Assay, Heparin

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008

88 I - - AZ Heparin

Date Published: 09/10/2009

Notes:All heparin products 3/10/2008


Chongqing Imperial Bio Chem Co

Date Published : 09/10/2009

5 Yanghe Sancun , 19-7 Citic Bank Building, Jiangbei Dist. , Chongqing, CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009


Chongqing Paiquiang Agribyproduct Co., Ltd

Date Published : 09/10/2009

158 Gonglongpo , Yudong , Chongqing, CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All APIs 3/16/2009


Fercy Personal Care Products Co., Ltd

Date Published : 05/10/2012

An'Wen Industrial Zone Pan County , Jinhua, Zhejiang CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 05/10/2012

Notes:All Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 05/10/2012

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 05/10/2012

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 05/10/2012

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 05/10/2012

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 05/10/2012

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 05/10/2012

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 05/10/2012

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 05/10/2012

Notes:All Drug Products


FriendsUnion(Tianjin) enterprises ltd.

Date Published : 09/17/2010

Suites 1808-9 Guohua Building, 857 Dagu- , Nan Road, Hexi , Tianjin,China , tianjin, CN-12 CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/17/2010

Notes:All drug products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/17/2010

Notes:All drug products

60 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

61 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

62 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

63 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

64 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

65 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

66 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products


Guangdong Pharmaceutical Factory #1

Date Published : 09/10/2009

91 Fangcun Dadao , Guangzhou, CHINA

61 G - - -- A-Bacterial Pt. II (Not Antibiotic)

Date Published: 09/10/2009

Notes:Active Pharmaceutical Ingredients 12/12/1997

61 H - - -- A-Bacterial Pt. III (Not Antibiotic)

Date Published: 09/10/2009

Notes:Active Pharmaceutical Ingredients 12/12/1997


Jiangsu Province Jianerkang Medical Dressing Co.

Date Published : 04/27/2012

Zhizi Town , Jintan City, Jiangsu, CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 04/27/2012

Notes:All Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 04/27/2012

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 04/27/2012

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 04/27/2012

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 04/27/2012

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 04/27/2012

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 04/27/2012

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 04/27/2012

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 04/27/2012

Notes:All Drug Products


Kunshan Chemicals & Pharmaceutical Factory

Date Published : 09/10/2009

No 242 Kun Tai Road , Kunshan City , Jiangsu, CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:8/30/2007

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:8/30/2007

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:8/30/2007

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:8/30/2007

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:8/30/2007

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:8/30/2007

Notes:8/30/2007

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:8/30/2007

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:8/30/2007


Nanjing Maohai Biotech Co.

Date Published : 10/18/2011

8 Developing Zone , Yaxi Town, Gaochun County , Nanjing, Jiangsu Province, CHINA

55 R - - 75 Crude Heparin (Pharmaceutic Necessity)

Date Published: 10/18/2011

Desc:Crude Heparin (Pharmaceutical Necessity)

61 L - - 08 Heparin Sodium (Anti-Coagulant)

Date Published: 10/18/2011

Desc:Heparin Sodium (Anti-Coagulant)


Nanjing Pharmaceutical Factory Co., Ltd.

Date Published : 05/20/2010

No. 9, Fangshui East Road, , Nanjing Chemical Industry Park , Nanjing, CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 05/20/2010

Notes:All Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 05/20/2010

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 05/20/2010

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 05/20/2010

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 05/20/2010

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 05/20/2010

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 05/20/2010

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 05/20/2010

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 05/20/2010

Notes:All Drug Products


Ningbo Smart Pharmaceutical Co., Ltd.

Date Published : 04/08/2011

Sec. C1, Ningbo Eco. & , Tech. Dev. Zone, Beilun District , Ningbo, Zhejiang CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 04/08/2011

Notes:All Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 04/08/2011

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 04/08/2011

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 04/08/2011

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 04/08/2011

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 04/08/2011

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 04/08/2011

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 04/08/2011

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 04/08/2011

Notes:All Drug Products


Northeast Pharmaceutical Group Co., Ltd.

Date Published : 09/10/2009

37 Zhonggong Bei Street , Tiexi District , Shenyang, Liaoning CHINA

45 - - - -- Food Additives (Human Use)

Date Published: 08/28/2010

Notes:All Pharmaceutical Products; *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products.; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

46 - - - -- Food Additives (Human Use)

Date Published: 08/28/2010

Notes:All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)

Date Published: 08/28/2010

Notes:*Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:10/30/2007;All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products;NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:10/30/2007 All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:10/30/2007 All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products;NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products;NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:10/30/2007; All Pharmaceutical Products *Note: The Agency has evidence to support the fact raw materials used in the production of finished drugs are being offered for import into the U.S. as food products; NOTE: Food additives/vitamins for food use are not subject to drug GMP requirements. Only food additives/vitamins manufactured by Northeast General Pharmaceutical Factory which are intended for pharmaceutical use are subject to DWPE


Shanghai Biochemial And Pharmaceutical Co Ltd

Date Published : 09/10/2009

Room A403, No. 494 Zhongxing Road , Shanghai, CHINA

55 R - - 75 Crude Heparin (Pharmaceutic Necessity)

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

55 R - - 99 Pharmaceutic Necessities, N.E.C.

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

57 D - - 38 Whole Blood (Human) Heparin (Blood and Blood Derivatives)

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

61 L - - 08 Heparin Sodium (Anti-Coagulant)

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

61 L - - 22 Anti-Coagulant Heparin Sol

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

61 L - - 30 Heparin Calcium (Anti-Coagulant)

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

74 L - - IS Heparin Coating Chemicals

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

80 N - - ZW Heparin Vascular access flush

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

81 J - - BR Test, Heparin Neutralization

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

81 J - - OX Analyzer, Heparin, Automated

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

81 K - - FF Assay, Heparin

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009

88 I - - AZ Heparin

Date Published: 09/10/2009

Notes:All heparin products 1/21/2009


Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd.

Date Published : 09/10/2009

387 Shangqui Road , Shanghai, CHINA

55 R - - 75 Crude Heparin (Pharmaceutic Necessity)

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

55 R - - 99 Pharmaceutic Necessities, N.E.C.

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

57 D - - 38 Whole Blood (Human) Heparin (Blood and Blood Derivatives)

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

61 L - - 08 Heparin Sodium (Anti-Coagulant)

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

61 L - - 22 Anti-Coagulant Heparin Sol

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

61 L - - 30 Heparin Calcium (Anti-Coagulant)

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

74 L - - IS Heparin Coating Chemicals

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

80 N - - ZW Heparin Vascular access flush

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

81 J - - BR Test, Heparin Neutralization

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

81 J - - OX Analyzer, Heparin, Automated

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

81 K - - FF Assay, Heparin

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009

88 I - - AZ Heparin

Date Published: 09/10/2009

Notes:All Heparin Products 1/21/2009


Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd.

Date Published : 09/10/2009

1317 Jianchuan Road, , Minhang District , Shanghai, CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All API's 1/21/2009 (original) 4/14/2009 (updated) Note: Other Shanghai No. 1 locations remain subject to DWPE for heparin products only.


Sichuan Pharmaceutical Co., Ltd.

Date Published : 05/08/2012

189 Hua Long Road , Pengzhou, Sichuan Province CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 05/08/2012

Notes:All drug products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 05/08/2012

Notes:All drug products

60 - - - -- Human and Animal Drugs

Date Published: 05/08/2012

Notes:All drug products

61 - - - -- Human and Animal Drugs

Date Published: 05/08/2012

Notes:All drug products

62 - - - -- Human and Animal Drugs

Date Published: 05/08/2012

Notes:All drug products

63 - - - -- Human and Animal Drugs

Date Published: 05/08/2012

Notes:All drug products

64 - - - -- Human and Animal Drugs

Date Published: 05/08/2012

Notes:All drug products

65 - - - -- Human and Animal Drugs

Date Published: 05/08/2012

Notes:All drug products

66 - - - -- Human and Animal Drugs

Date Published: 05/08/2012

Notes:All drug products


Tianjin Boai NKY International Ltd.

Date Published : 09/17/2010

Suites 1808-9 Guohua Building , Dagu-Nan Road, Hexi District , Tianjin, CN-12 CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/17/2010

Notes:All drug products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/17/2010

Notes:All drug products

60 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

61 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

62 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

63 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

64 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

65 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

66 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products


Tianjin Boai Pharmaceutical Co. Ltd

Date Published : 09/17/2010

No.4, Ronghua Road, Xiqing District , Yong Hong Industry Zone, Nan He Town , Tianjin, CN-12 CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/17/2010

Notes:All drug products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/17/2010

Notes:All drug products

60 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

61 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

62 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

63 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

64 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

65 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

66 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products


Tianjin Boai Pharmaceutical Ltd. co.

Date Published : 09/17/2010

6, Rd Ronghua , Town Nanhe, Dist. Xiqing , Tianjin , Tianjin, CN-12 CHINA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/17/2010

Notes:All drug products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/17/2010

Notes:All drug products

60 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

61 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

62 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

63 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

64 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

65 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products

66 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All drug products


Zhejiang Casing Animal By-Products Co.,Ltd.

Date Published : 10/18/2011

369 Dong Xing Road , Tonglu Economic Developing District , Hangzhou, Zhejiang Province CN-33 CHINA

61 L - - 08 Heparin Sodium (Anti-Coagulant)

Date Published: 10/18/2011

Desc:Heparin Sodium (Anti-coagulant)


DENMARK

Leo Pharma A/S

Date Published : 03/01/2011

Industriparken 55 , Ballerup, DENMARK

61 L - - 35 Tinzaparin Sodium (Anti-Coagulant)

Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.

61 L - - 99 Anti-Coagulant, N.E.C.

Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.


Leo Pharmaceutical Products

Date Published : 03/01/2011

Park Alle 26 , Vejen, DENMARK

61 L - - 35 Tinzaparin Sodium (Anti-Coagulant)

Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.

61 L - - 99 Anti-Coagulant, N.E.C.

Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.


Leo Pharmaceutical Products

Date Published : 03/01/2011

A 8 , Copenhagen, DENMARK

61 L - - 35 Tinzaparin Sodium (Anti-Coagulant)

Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.

61 L - - 99 Anti-Coagulant, N.E.C.

Date Published: 03/01/2011

Desc:Tinzaparin Sodium (Innohep); Anti-coagulent; n.e.c.


FRANCE

Compagnie Oris Industrie Lpib

Date Published : 09/10/2009

B.P. #2 91 Gif-Sur-Yvette , Saclay, FRANCE

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 Injection

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection


Compagnie Oris Industrie, S.A.

Date Published : 09/10/2009

Centre D'Etudes Nucleaires De Marcoule , BP 171f , Bagnols, FRANCE

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Selenomethionine 75 injection


Societe Chimique Grevis

Date Published : 09/10/2009

Avenue De La Paix , Limay, FRANCE

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Sterile bulk pharmaceutical chemicals 8/10/1989


GERMANY

Bavarian Red Cross - Augsburg

Date Published : 09/10/2009

Westheimer Strasse 80 , Augsburg, GERMANY

57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag

Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998

66 U - - -- Nat Body Part (Invivo Only)

Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998


Bavarian Red Cross - Bayreuth

Date Published : 09/10/2009

Dr. Franz-Strasse 3 , Bayreuth, GERMANY

57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag

Date Published: 09/10/2009

Desc:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998
Notes:Notes

66 U - - -- Nat Body Part (Invivo Only)

Date Published: 09/10/2009

Desc:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998
Notes:Notes


Bavarian Red Cross - Munich

Date Published : 09/10/2009

Herzog-Heinrich Strasse 4 , Munich, GERMANY

57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag

Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998

66 U - - -- Nat Body Part (Invivo Only)

Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998


Bavarian Red Cross - Nurnberg

Date Published : 09/10/2009

Prof. Ernst Nathan Str. 1 , Nurnberg, GERMANY

57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag

Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998

66 U - - -- Nat Body Part (Invivo Only)

Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998


Bavarian Red Cross - Regensburg

Date Published : 09/10/2009

Hoher Kreuz Weg 7 , Regensburg, GERMANY

57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag

Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998

66 U - - -- Nat Body Part (Invivo Only)

Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998


Bavarian Red Cross - Wurzburg

Date Published : 09/10/2009

Klinikstrasse 5 , Wurzburg, GERMANY

57 - - - -- Bio & Licensed In-Vivo & In-Vitro Diag

Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998

66 U - - -- Nat Body Part (Invivo Only)

Date Published: 09/10/2009

Notes:All Products (including Whole Blood; Red Blood Cells and Whole Blood CPDA-1; and Recovered Plasma). Bavarian Red Cross Operations have multiple facilities operating under license # 1002) 12/29/1998


Heel Gmbh , Biologische Heilmittel

Date Published : 09/10/2009

Ruhrstr, 14 , Baden, GERMANY

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All Injectable Drug Products (4/26/1995) Revised (5/5/2003): All drug products claimed or purported to be sterile and all drug products which by virtue of theri intended use should be sterile, i.e. opthalmic products. Other homeopathic drug products imported from the subject firm and labeled "Not for injection" or "For oral use" are not recommended for DWPE.


Transo-Pharm Handels-GmbH

Date Published : 04/11/2011

Bueltbek 5 , Siek, GERMANY

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 04/11/2011

Notes:All Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 04/11/2011

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 04/11/2011

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 04/11/2011

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 04/11/2011

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 04/11/2011

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 04/11/2011

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 04/11/2011

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 04/11/2011

Notes:All Drug Products


INDIA

Aurobindo Pharma Limited

Date Published : 03/01/2011

Unit VI, Cephalosporin S.B.P., Survey , No. 329/39 & 329/47, Chitkul Village , Hyderabad, Andhra Pradesh, INDIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 03/01/2011


56 - - - -- Antibiotics (Human/Animal)

Date Published: 03/01/2011


60 - - - -- Human and Animal Drugs

Date Published: 03/01/2011


61 - - - -- Human and Animal Drugs

Date Published: 03/01/2011


62 - - - -- Human and Animal Drugs

Date Published: 03/01/2011


63 - - - -- Human and Animal Drugs

Date Published: 03/01/2011


64 - - - -- Human and Animal Drugs

Date Published: 03/01/2011


65 - - - -- Human and Animal Drugs

Date Published: 03/01/2011


66 - - - -- Human and Animal Drugs

Date Published: 03/01/2011

Aurobindo Pharma Limited

Date Published : 02/07/2011

Unit VI, Cephalosporin S.B.P., Survey , No. 329/39 & 329/47, Chitkul Village , Hyderabad, Andhra Pradesh, INDIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 02/07/2011

Notes:All Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 02/28/2011


60 - - - -- Human and Animal Drugs

Date Published: 02/07/2011

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 02/07/2011

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 02/07/2011

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 02/07/2011

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 02/07/2011

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 02/07/2011

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 02/07/2011

Notes:All Drug Products


Claris Lifesciences Limited

Date Published : 06/03/2010

Chacharwadi-vasana , Ahmedabad, Gujarat INDIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 06/03/2010

Notes:All Sterile Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 06/03/2010

Notes:All Sterile Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 06/03/2010

Notes:All Sterile Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 06/03/2010

Notes:All Sterile Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 06/03/2010

Notes:All Sterile Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 06/03/2010

Notes:All Sterile Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 06/03/2010

Notes:All Sterile Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 06/03/2010

Notes:All Sterile Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 06/03/2010

Notes:All Sterile Drug Products


Fleming Laboratories

Date Published : 04/08/2011

Survey No. 270, Navabpet Village , Sivampet Mandal, INDIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 04/08/2011


56 - - - -- Antibiotics (Human/Animal)

Date Published: 04/08/2011


60 - - - -- Human and Animal Drugs

Date Published: 04/08/2011


61 - - - -- Human and Animal Drugs

Date Published: 04/08/2011


62 - - - -- Human and Animal Drugs

Date Published: 04/08/2011


63 - - - -- Human and Animal Drugs

Date Published: 04/08/2011


64 - - - -- Human and Animal Drugs

Date Published: 04/08/2011


65 - - - -- Human and Animal Drugs

Date Published: 04/08/2011


66 - - - -- Human and Animal Drugs

Date Published: 04/08/2011

Fleming Laboratories Limited

Date Published : 04/11/2011

Plot No. 48, Temple Rock Enclave , Tarbund X Road , Secunderabad, INDIA

56 - - - -- Antibiotics (Human/Animal)

Date Published: 04/11/2011

Notes:All Drug Products

73 - - - -- Anesthesiology

Date Published: 04/11/2011

Notes:All Drug Products

74 - - - -- Cardiovascular

Date Published: 04/11/2011

Notes:All Drug Products

76 - - - -- Dental

Date Published: 04/11/2011

Notes:All Drug Products

77 - - - -- Ear,Nose And Throat

Date Published: 04/11/2011

Notes:All Drug Products

78 - - - -- Gastroenterological & Urological

Date Published: 04/11/2011

Notes:All Drug Products

79 - - - -- General & Plastic Surgery

Date Published: 04/11/2011

Notes:All Drug Products

80 - - - -- General Hospital/Personal Use

Date Published: 04/11/2011

Notes:All Drug Products

84 - - - -- Neurological

Date Published: 04/11/2011

Notes:All Drug Products

85 - - - -- Obstetrical & Gynecological

Date Published: 04/11/2011

Notes:All Drug Products

86 - - - -- Ophthalmic

Date Published: 04/11/2011

Notes:All Drug Products

87 - - - -- Orthopedic

Date Published: 04/11/2011

Notes:All Drug Products

89 - - - -- Physical Medicine

Date Published: 04/11/2011

Notes:All Drug Products

90 - - - -- Radiological

Date Published: 04/11/2011

Notes:All Drug Products


Nivedita Chemicals P lTd

Date Published : 11/23/2011

A14 MIDC Andheri East , Mumbai, IN-MH INDIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

60 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic)

Date Published: 11/23/2011

Desc:Chlorpheniramine maleate

61 X - - 29 Pyrilamine Maleate (Anti-Histaminic)

Date Published: 11/23/2011

Desc:Pyrilamine maleate Pyrilamine maleate USP

61 X - - 29 Pyrilamine Maleate (Anti-Histaminic)

Date Published: 11/23/2011

Desc:Chlorpheniramine maleate

61 X - - 99 Anti-Histaminic N.E.C.

Date Published: 11/23/2011

Desc:Pyrilamine maleate Pyrilamine maleate USP

61 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

62 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

63 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

64 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

65 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

66 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate


Nivedita Chemicals Pvt. Ltd.

Date Published : 11/23/2011

A-14 M.I.D.C. Andheri (East) , Maharashtra, MS INDIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

60 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic)

Date Published: 11/23/2011

Desc:Chlorpheniramine maleate

61 X - - 29 Pyrilamine Maleate (Anti-Histaminic)

Date Published: 11/23/2011

Desc:Chlorpheniramine maleate

61 X - - 29 Pyrilamine Maleate (Anti-Histaminic)

Date Published: 11/23/2011

Desc:Pyrilamine maleate Pyrilamine maleate USP

61 X - - 99 Anti-Histaminic N.E.C.

Date Published: 11/23/2011

Desc:Pyrilamine maleate Pyrilamine maleate USP

61 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

62 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

63 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

64 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

65 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate

66 - - - -- Human and Animal Drugs

Date Published: 11/23/2011

Notes:Chlorpheniramine maleate


Ranbaxy Laboratories, Limited

Date Published : 09/10/2009

Paonta Sahib , Himachal Pradesh , Simour District, INDIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.


Ranbaxy Laboratories, Ltd.

Date Published : 09/10/2009

Industrial Area No. 3 , Madhya Pradesh , Dewas, Mp INDIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products and APIs 9/16/2008 NOTE: This firm is the sole source of Ganciclovir API. Districts should contat DIOP if entries of Ganciclovir API or finished dosage forms are offered for import.


Stericon Pharma Pvt. Ltd.

Date Published : 01/13/2011

No. 9, Sub Layout Of Plot 9 , 1st Phase Bommasandra Ind. Area , Bangalore, Karnataka, INDIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 01/13/2011

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 01/13/2011

Notes:All Drug Products


Wintac Limited

Date Published : 03/27/2012

163 Reservior Str , Bangalore, INDIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 03/27/2012


60 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


61 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


62 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


63 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


64 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


65 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


66 - - - -- Human and Animal Drugs

Date Published: 03/27/2012

Wintac Limited

Date Published : 03/27/2012

54/1, Boodihal Village, Nelamangala , Taluk , Bangalore, INDIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 03/27/2012


60 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


61 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


62 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


63 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


64 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


65 - - - -- Human and Animal Drugs

Date Published: 03/27/2012


66 - - - -- Human and Animal Drugs

Date Published: 03/27/2012

Yag Mag Labs Private Limited

Date Published : 09/13/2011

Survey No. 10, Gaddapotharam Village, , Jinnatam Mandel , Medak District, AP, INDIA

60 L - - 69 Tramadol HCl (Analgesic)

Date Published: 09/13/2011

Desc:Tramadol HCl (Analgesic)

60 L - - 99 Analgesic, N.E.C.

Date Published: 09/13/2011

Desc:Tramadol HCl (Analgesic)

64 H - - 02 Guaifenesin (Expectorant)

Date Published: 09/13/2011

Desc:Guaifensein (Expectorant)


ITALY

Topchem SRL

Date Published : 09/10/2009

Viale Andrea Doria 17 , Milano, MI ITALY

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk drugs 8/4/1992


MEXICO

Compania Internacional de Comercio, S.A. de C.V.

Date Published : 05/17/2012

Calle Monzon No. 184 , Col.Cerro de la Estrella , Mexico, D.F., MEXICO

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 05/17/2012


56 - - - -- Antibiotics (Human/Animal)

Date Published: 05/17/2012


60 - - - -- Human and Animal Drugs

Date Published: 05/17/2012


61 - - - -- Human and Animal Drugs

Date Published: 05/17/2012


62 - - - -- Human and Animal Drugs

Date Published: 05/17/2012


63 - - - -- Human and Animal Drugs

Date Published: 05/17/2012


64 - - - -- Human and Animal Drugs

Date Published: 05/17/2012


65 - - - -- Human and Animal Drugs

Date Published: 05/17/2012


66 - - - -- Human and Animal Drugs

Date Published: 05/17/2012

Farma Quimia S.A. de C.V.

Date Published : 02/23/2012

Av Andre Marie Ampere No 11 , Parque Industrial Cuamatla , Cuautitlan Izcalli, Mex MEXICO

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 02/23/2012

Notes:All Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 02/23/2012

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 02/23/2012

Notes:All Drug Products


Laboratorios Jaloma S.A. de C.V.

Date Published : 03/09/2012

Aquiles Serdan No. 438 , Guadalajara, JAL MEXICO

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 03/09/2012


60 - - - -- Human and Animal Drugs

Date Published: 03/09/2012


61 - - - -- Human and Animal Drugs

Date Published: 03/09/2012


62 - - - -- Human and Animal Drugs

Date Published: 03/09/2012


63 - - - -- Human and Animal Drugs

Date Published: 03/09/2012


64 - - - -- Human and Animal Drugs

Date Published: 03/09/2012


65 - - - -- Human and Animal Drugs

Date Published: 03/09/2012


66 - - - -- Human and Animal Drugs

Date Published: 03/09/2012

Selder S.A. de C.V.

Date Published : 04/10/2012

Fernando Villapando #48 , Colonia Guadalupe Inn , Mexico, D.F., MEXICO

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 04/10/2012

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 04/10/2012

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 04/10/2012

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 04/10/2012

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 04/10/2012

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 04/10/2012

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 04/10/2012

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 04/10/2012

Notes:All Drug Products


POLAND

Nobilus Ent

Date Published : 03/05/2012

Ul Metalowa 6a , Kutno, POLAND

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 03/05/2012

Notes:All Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 03/05/2012

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products


Nobilus Ent

Date Published : 03/05/2012

Swarzewska 45 , Warszawa, POLAND

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 03/05/2012

Notes:All Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 03/05/2012

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 03/05/2012

Notes:All Drug Products


SERBIA

Hemofarm a.d.

Date Published : 04/26/2012

Beogradski put bb , Vrsac, SERBIA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 04/26/2012


60 - - - -- Human and Animal Drugs

Date Published: 04/26/2012


61 - - - -- Human and Animal Drugs

Date Published: 04/26/2012


62 - - - -- Human and Animal Drugs

Date Published: 04/26/2012


63 - - - -- Human and Animal Drugs

Date Published: 04/26/2012


64 - - - -- Human and Animal Drugs

Date Published: 04/26/2012


65 - - - -- Human and Animal Drugs

Date Published: 04/26/2012


66 - - - -- Human and Animal Drugs

Date Published: 04/26/2012

SOUTH AFRICA

Clover Production

Date Published : 09/17/2010

200 Constantia Drive , Weltevreden Park , johannesburg, ZA-GT SOUTH AFRICA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/17/2010

Notes:All sterile drug products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/17/2010

Notes:All sterile drug products

60 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All sterile drug products

61 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All sterile drug products

62 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All sterile drug products

63 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All sterile drug products

64 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All sterile drug products

65 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All sterile drug products

66 - - - -- Human and Animal Drugs

Date Published: 09/17/2010

Notes:All sterile drug products


SPAIN

Dysers S.A.L.

Date Published : 09/10/2009

Depositos 12 , Segovia, SPAIN

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:Non-sterile bulk drug products 5/1/1992


TURKEY

Ansa

Date Published : 09/10/2009

UNKNOWN , Izmit, TURKEY

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

UNITED ARAB EMIRATES

Gulf Pharmaceutical Industries

Date Published : 01/31/2012

Airport Road, Digdaga , Ras Al-Khaimah, UNITED ARAB EMIRATES

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 01/31/2012

Notes:All Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 01/31/2012

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 01/31/2012

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 01/31/2012

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 01/31/2012

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 01/31/2012

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 01/31/2012

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 01/31/2012

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 01/31/2012

Notes:All Drug Products


UNITED KINGDOM

A Nelson & Co., Ltd.

Date Published : 06/26/2012

5-9 Endeavour Way , Wimbledon, London UNITED KINGDOM

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 06/26/2012


60 - - - -- Human and Animal Drugs

Date Published: 06/26/2012


61 - - - -- Human and Animal Drugs

Date Published: 06/26/2012


62 - - - -- Human and Animal Drugs

Date Published: 06/26/2012


63 - - - -- Human and Animal Drugs

Date Published: 06/26/2012


64 - - - -- Human and Animal Drugs

Date Published: 06/26/2012


65 - - - -- Human and Animal Drugs

Date Published: 06/26/2012


66 - - - -- Human and Animal Drugs

Date Published: 06/26/2012

Fresenius Kabi Oncology Plc

Date Published : 09/10/2009

Lion Court Farnham Road , Bordon, Hampshire UNITED KINGDOM

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 09/10/2009

Notes:All finished pharmaceutical products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:All finished pharmaceutical products

60 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products

61 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products

62 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products

63 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products

64 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products

65 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products

66 - - - -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All finished pharmaceutical products


Hampshire Chemicals, Ltd.

Date Published : 09/10/2009

Seal Sands Road , Middlesborough, Cleveland UNITED KINGDOM

56 - - S -- Antibiotics (Human/Animal)

Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996

60 - - S -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996

61 - - S -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996

62 - - S -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996

63 - - S -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996

64 - - S -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996

65 - - S -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996

66 - - S -- Human and Animal Drugs

Date Published: 09/10/2009

Notes:All bulk pharmaceuticals 1/26/1996


VENEZUELA

LABORATORIOS LO OFTALMI CA

Date Published : 05/14/2010

CTO. EMPRESARIAL "RS", CALLE 6 , ZONA INDUSTRIAL LA URBINA , Caracas, VE-NOTA VENEZUELA

56 - - - -- Antibiotics (Human/Animal)

Date Published: 05/14/2010

Notes:All Drug Products

73 - - - -- Anesthesiology

Date Published: 05/14/2010

Notes:All Drug Products

74 - - - -- Cardiovascular

Date Published: 05/14/2010

Notes:All Drug Products

76 - - - -- Dental

Date Published: 05/14/2010

Notes:All Drug Products

77 - - - -- Ear,Nose And Throat

Date Published: 05/14/2010

Notes:All Drug Products

78 - - - -- Gastroenterological & Urological

Date Published: 05/14/2010

Notes:All Drug Products

79 - - - -- General & Plastic Surgery

Date Published: 05/14/2010

Notes:All Drug Products

80 - - - -- General Hospital/Personal Use

Date Published: 05/14/2010

Notes:All Drug Products

84 - - - -- Neurological

Date Published: 05/14/2010

Notes:All Drug Products

85 - - - -- Obstetrical & Gynecological

Date Published: 05/14/2010

Notes:All Drug Products

86 - - - -- Ophthalmic

Date Published: 05/14/2010

Notes:All Drug Products

87 - - - -- Orthopedic

Date Published: 05/14/2010

Notes:All Drug Products

89 - - - -- Physical Medicine

Date Published: 05/14/2010

Notes:All Drug Products

90 - - - -- Radiological

Date Published: 05/14/2010

Notes:All Drug Products


Laboratorios L.O. Oftalmi, C.A.

Date Published : 05/14/2010

Calle 6, Centro Empresarial R.S. , Zona Industrial de La Urbina , Caracas, VENEZUELA

55 - - - -- Pharm Necess & Ctnr For Drug/Bio

Date Published: 05/14/2010

Notes:All Drug Products

56 - - - -- Antibiotics (Human/Animal)

Date Published: 05/14/2010

Notes:All Drug Products

60 - - - -- Human and Animal Drugs

Date Published: 05/14/2010

Notes:All Drug Products

61 - - - -- Human and Animal Drugs

Date Published: 05/14/2010

Notes:All Drug Products

62 - - - -- Human and Animal Drugs

Date Published: 05/14/2010

Notes:All Drug Products

63 - - - -- Human and Animal Drugs

Date Published: 05/14/2010

Notes:All Drug Products

64 - - - -- Human and Animal Drugs

Date Published: 05/14/2010

Notes:All Drug Products

65 - - - -- Human and Animal Drugs

Date Published: 05/14/2010

Notes:All Drug Products

66 - - - -- Human and Animal Drugs

Date Published: 05/14/2010

Notes:All Drug Products

Import Alert 66-40 from FDA--Red List of Foreign Processors: "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"; (2024)

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