Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
01 1Bioquim
02 1Centrient Pharmaceuticals
03 1HRV Global Life Sciences
04 1ACS DOBFAR SPA
05 2Aurobindo Pharma Limited
06 2Bristol Myers Squibb
07 1Daewoong Pharmaceutical
08 1Fresenius Kabi AB Brunna
09 1Fresenius Kabi Anti-Infectives
10 3GSK
11 1Istituto Biochimico Italiano Giovanni Lorenzini SpA
12 1KDL Biotech Limited IN 400 018 Mumbai
13 1Kaliberr Labs
14 1Kopran
15 1Parabolic Drugs
16 1Penam Laboratories
17 2Rajasthan Antibiotics
18 1Reyoung pharmaceutical
19 2Sandoz B2B
20 1Sichuan Renan Pharmaceutical
21 1Sterile India Pvt. Ltd
22 1TAPI Technology & API Services
23 1Vaishali Pharma Ltd
01 2China
02 12India
03 1Israel
04 3Italy
05 1Netherlands
06 1South Korea
07 1Spain
08 1Sweden
09 2Switzerland
10 2U.S.A
11 3United Kingdom
01 2Active
02 8Inactive
03 19Blank
01 6Valid
02 2Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
04 19Blank
01 1218MF11024
02 1227MF10133
03 27Blank
01 1WC-0010
02 1WC-0023
03 1WC-0121
04 1WC-0378A2
05 1WC-0420
06 1WC-0420-A
07 23Blank
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Certificate Number : R1-CEP 2003-207 - Rev 07
Issue Date : 2019-04-24
Type : Chemical
Substance Number : 661
Status : Valid
Registration Number : 227MF10133
Registrant's Address : Bhai Mohan Singh Nagar, Toansa, District SBS Nagar (Nawanshahr), Punjab-144 533, India
Initial Date of Registration : 2015-04-30
Latest Date of Registration : --
Date of Issue : 2022-05-19
Valid Till : 2025-05-27
Written Confirmation Number : WC-0010
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38038
Submission : 2023-04-18
Status : Active
Type : II
Certificate Number : R1-CEP 1998-025 - Rev 08
Issue Date : 2021-06-10
Type : Chemical
Substance Number : 661
Status : Valid
NDC Package Code : 66558-0211
Start Marketing Date : 2022-07-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8844
Submission : 1990-11-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13434
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13557
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 1996-091 - Rev 08
Issue Date : 2021-02-10
Type : Chemical
Substance Number : 661
Status : Valid
Certificate Number : R1-CEP 2001-241 - Rev 01
Issue Date : 2009-10-16
Type : Chemical
Substance Number : 661
Status : Withdrawn by Holder
Certificate Number : R0-CEP 1997-131 - Rev 01
Issue Date : 2004-11-17
Type : Chemical
Substance Number : 661
Status : Withdrawn by EDQM F...
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