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 1ACS DOBFAR SPA
04 1ADL BioPharma
05 1Anhui Sinotech Industrial
06 1Arcadia Lifescience
07 2Aurobindo Pharma Limited
08 1Bayer AG
09 3Bristol Myers Squibb
10 1CSPC Pharmaceutical Group
11 1CordenPharma
12 1Fermenta Biotech Limited
13 1Fresenius Kabi AB Brunna
14 3GSK
15 1Inner Mongolia Changsheng Pharmaceutical
16 1Kopran
17 2North China Pharmaceutical Co., Ltd.
18 1Oman Chemicals & Pharmaceuticals LLC
19 1Parabolic Drugs
20 1Penam Laboratories
21 1Pfizer Inc
22 1Pierrel
23 1Plantex Ltd.
24 1RANBAXY LABORATORIES LIMITED
25 1Royal DSM
26 1Sandoz B2B
27 1Sinopharm Weiqida Pharmaceutical Co Ltd
28 1Tecoland Corporation
29 1Vaishali Pharma Ltd
30 1YUNGJIN PHARM. CO. LTD
31 1Zhuhai United Laboratories Co ., Ltd.
32 7Blank
01 1Canada
02 7China
03 2Germany
04 8India
05 2Israel
06 2Italy
07 2Netherlands
08 1Oman
09 1South Korea
10 1Spain
11 1Sweden
12 1Switzerland
13 5U.S.A
14 3United Kingdom
15 7Blank
01 10Active
02 25Inactive
03 9Blank
01 9Valid
02 2Withdrawn by EDQM Failure to CEP procedure
03 3Withdrawn by Holder
04 30Blank
01 1219MF10142
02 1222MF10149
03 1230MF10038
04 41Blank
01 1WC-0010
02 1WC-0121
03 42Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26505
Submission : 2012-10-30
Status : Active
Type : II
Certificate Number : R1-CEP 2011-297 - Rev 03
Issue Date : 2021-10-06
Type : Chemical
Substance Number : 168
Status : Valid
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 : 13423
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-08-01
Pay. Date : 2016-10-14
DMF Number : 30815
Submission : 2016-08-02
Status : Active
Type : II
Certificate Number : R1-CEP 2002-178 - Rev 02
Issue Date : 2015-02-16
Type : Chemical
Substance Number : 168
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38056
Submission : 2023-03-30
Status : Active
Type : II
Certificate Number : CEP 2022-507 - Rev 00
Issue Date : 2024-05-21
Type : Chemical
Substance Number : 168
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35735
Submission : 2021-03-26
Status : Active
Type : II
Certificate Number : R0-CEP 2020-133 - Rev 00
Issue Date : 2022-04-05
Type : Chemical
Substance Number : 168
Status : Valid
NDC Package Code : 32903-014
Start Marketing Date : 2023-11-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13364
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13408
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13438
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13514
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13728
Submission : 1998-09-01
Status : Inactive
Type : II
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