Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1TAPI Technology & API Services
03 2Aurobindo Pharma Limited
04 3Bristol Myers Squibb
05 1Fermenta Biotech Limited
06 1Fresenius Kabi Anti-Infectives
07 1GSK
08 1Parabolic Drugs
09 1Penam Laboratories
10 1Rajasthan Antibiotics
11 1Ribbon S.r.l. IT 20145 Milano
12 1Sandoz B2B
13 1Vaishali Pharma Ltd
14 1Blank
01 7India
02 1Israel
03 2Italy
04 1Netherlands
05 1Switzerland
06 3U.S.A
07 1United Kingdom
08 1Blank
01 2Active
02 7Inactive
03 8Blank
01 2Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
04 12Blank
01 17Blank
01 1WC-0010
02 1WC-0023
03 1WC-0121
04 14Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Date of Issue : 2022-05-19
Valid Till : 2025-05-27
Written Confirmation Number : WC-0010
Address of the Firm :
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13657
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-05-26
Pay. Date : 2020-05-08
DMF Number : 19553
Submission : 2006-06-20
Status : Active
Type : II
Certificate Number : CEP 2010-177 - Rev 03
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 663
Status : Valid
Date of Issue : 2019-07-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0121
Address of the Firm :
NDC Package Code : 65862-278
Start Marketing Date : 2024-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13497
Submission : 1998-09-01
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13221
Submission : 1998-04-30
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13429
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13431
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13558
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13798
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 1996-023 - Rev 04
Issue Date : 2016-07-25
Type : Chemical
Substance Number : 663
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13352
Submission : 1998-09-01
Status : Inactive
Type : II
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