Minakem is manufacturing small molecules APIs including corticosteroids
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01 1Minakem (formerly Delmar Chemicals)
02 1Cohance Lifesciences
03 1Tenatra Chemie
04 1AXYNTIS Group
05 1Arevipharma
06 1Bausch Health
07 1Biotechnica DWC
08 1Centaur Pharmaceuticals
09 1Cilag AG
10 1Darmerica
11 2F. Hoffmann-La Roche
12 1Global Calcium
13 1Guangzhou Tosun Pharmaceutical
14 1Helsinn Advanced Synthesis
15 1MSN Laboratories
16 1Maithili Life Sciences
17 1Maithri Drugs
18 1Merck & Co
19 1Patheon
20 1Procos
21 1Royal DSM
22 1SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL
23 1Sami-Sabinsa Group
24 1Surajlok Chemicals
25 1Unichem Laboratories Limited
26 1Blank
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01 1Algeria
02 2Canada
03 2China
04 1France
05 1Germany
06 10India
07 1Italy
08 1Netherlands
09 4Switzerland
10 3U.S.A
11 1Blank
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01 6Active
02 6Inactive
03 15Blank
01 5Valid
02 22Blank
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01 1221MF10103
02 1227MF10212
03 25Blank
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01 1WC-0455
02 26Blank
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01 120210512-211-J-632
02 26Blank
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01 145941-3051
02 146016-1012
03 151927-4441
04 171052-386
05 171666-011
06 22Blank
01 27Blank
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-27
Pay. Date : 2020-09-29
DMF Number : 35024
Submission : 2020-08-15
Status : Active
Type : II
Date of Issue : 2022-11-18
Valid Till : 2025-09-30
Written Confirmation Number : WC-0455
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10593
Submission : 1993-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5505
Submission : 1984-07-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39637
Submission : 2024-03-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8952
Submission : 1991-01-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6939
Submission : 1987-04-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11972
Submission : 1996-05-10
Status : Inactive
Type : II
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A Lefaxin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lefaxin, including repackagers and relabelers. The FDA regulates Lefaxin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lefaxin 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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