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

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01 1Bioquim
02 1Tenatra Exports
03 1ACS DOBFAR SPA
04 1ADL BioPharma
05 1Anker Farm
06 3Aurobindo Pharma Limited
07 1Bayer AG
08 1Boehringer Ingelheim GmbH
09 1Bristol Myers Squibb
10 1CordenPharma
11 1DPB Pharma
12 1Daewoong Pharmaceutical
13 1Fermenta Biotech Limited
14 1GSK
15 1Gurvey & Berry
16 1Hangzhou Think Chemical Co.Ltd
17 2Inner Mongolia Changsheng Pharmaceutical
18 1Nanjing Dorra Pharmaceutical Technology Co.,Ltd
19 1North China Pharmaceutical Co., Ltd.
20 1Otto Brandes
21 1Parabolic Drugs
22 1Penam Laboratories
23 1Reyoung pharmaceutical
24 1Royal DSM
25 1RusBioPharm
26 2Sandoz B2B
27 1Teena Labs
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01 1Canada
02 6China
03 4Germany
04 9India
05 1Italy
06 1Netherlands
07 1Russia
08 1South Korea
09 2Spain
10 2Switzerland
11 2U.S.A
12 1United Kingdom
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01 3Active
02 7Inactive
03 21Blank
01 3Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 27Blank
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01 1218MF11025
02 1301MF10028
03 1302MF10096
04 1307MF10054
05 27Blank
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01 2WC-0023
02 1WC-0121
03 1WC-0470
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01 15125
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Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13212
Submission : 1998-04-30
Status : Active
Type : II
Certificate Number : R1-CEP 1999-188 - Rev 03
Issue Date : 2018-01-15
Type : Chemical
Substance Number : 167
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39728
Submission : 2024-04-06
Status : Active
Type : II
Certificate Number : CEP 2024-308 - Rev 00
Issue Date : 2025-02-19
Type : Chemical
Substance Number : 167
Status : Valid
Registration Number : 307MF10054
Registrant's Address : Industry Zone, Tuoketuo, Hohhot, Inner Mongolia, China
Initial Date of Registration : 2025-04-16
Latest Date of Registration :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13777
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R2-CEP 1995-031 - Rev 05
Issue Date : 2022-02-21
Type : Chemical
Substance Number : 167
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13516
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13779
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17546
Submission : 2004-07-19
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13435
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13297
Submission : 1998-09-01
Status : Inactive
Type : II

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A Pentrex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentrex, including repackagers and relabelers. The FDA regulates Pentrex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentrex 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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