Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.

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01 1Bioquim
02 2ACS DOBFAR SPA
03 1Akums Lifesciences
04 2Aurobindo Pharma Limited
05 3Bristol Myers Squibb
06 1Centrient Pharmaceuticals
07 1CordenPharma
08 1DPB Pharma
09 1Fresenius Kabi AB Brunna
10 1Fuan Pharmaceutical
11 1GSK
12 1Istituto Biochimico Italiano Giovanni Lorenzini SpA
13 1Penam Laboratories
14 1Reyoung pharmaceutical
15 2Sandoz B2B
16 1Sichuan Renan Pharmaceutical
17 1Sterile India Pvt. Ltd
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01 3China
02 1Germany
03 6India
04 3Italy
05 1Netherlands
06 1Spain
07 1Sweden
08 2Switzerland
09 3U.S.A
10 1United Kingdom
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01 4Active
02 9Inactive
03 9Blank
01 2Valid
02 20Blank
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01 22Blank
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01 2WC-0121
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01 165862-276
02 165862-499
03 166558-0203
04 19Blank
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Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24678
Submission : 2011-02-22
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13743
Submission : 1998-09-01
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13432
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13553
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15245
Submission : 2001-01-23
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13386
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13216
Submission : 1998-04-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20957
Submission : 2007-10-18
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13433
Submission : 1998-09-01
Status : Inactive
Type : II

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A Bristopen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bristopen, including repackagers and relabelers. The FDA regulates Bristopen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bristopen API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Bristopen supplier is an individual or a company that provides Bristopen active pharmaceutical ingredient (API) or Bristopen finished formulations upon request. The Bristopen suppliers may include Bristopen API manufacturers, exporters, distributors and traders.
click here to find a list of Bristopen suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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