Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 2Minakem
02 2Granules India Limited
03 2Metrochem API Private Limited
04 3Dr. Reddy's Laboratories
05 2Alkem Laboratories
06 2Aurobindo Pharma Limited
07 1Chromo Laboratories
08 2Cipla
09 1Everest Organics
10 3F.I.S. Fabbrica Italiana Sintetici
11 4Glenmark Life Sciences
12 1HEC Pharm
13 5Hetero Drugs
14 5Jubilant Generics
15 1LONZEAL PHARMACEUTICALS CO LTD
16 1Lee Pharma
17 1Lupin Ltd
18 3MSN Laboratories
19 2Macleods Pharmaceuticals Limited
20 1Murli Krishna Pharma
21 1Ningbo Menovo Pharmaceutical
22 1Perrigo API India Private Limited
23 1RANBAXY LABORATORIES LIMITED
24 2Raks Pharma
25 2Shouguang Fukang Pharmaceutical Co., Ltd
26 1Srini Pharmaceuticals
27 2Sun Pharmaceutical Industries Limited
28 2Torrent Pharmaceuticals Limited
29 1UQUIFA
30 1Vasudha Pharma Chem
31 3Viatris
32 1ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.
33 1Zhejiang Yongtai Technology
34 2Zydus Lifesciences
01 1ESOMEPRAZOLE
02 2ESOMEPRAZOLE MAGNESIUM
03 1ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) USP
04 1ESOMEPRAZOLE MAGNESIUM (AMORPHOUS, NON-STERILE BULK DRUG SUBSTANCE)
05 1ESOMEPRAZOLE MAGNESIUM AMORPHOUS (PROCESS-2) USP
06 1ESOMEPRAZOLE MAGNESIUM AMORPHOUS-USP
07 1ESOMEPRAZOLE MAGNESIUM DELAYED - RELEASE PELLETS
08 1ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE PELLETS (25.82% W/W)
09 1ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE PELLETS (AS 20.94%W/W OF ESOMEPRAZOLE)
10 13ESOMEPRAZOLE MAGNESIUM DIHYDRATE
11 2ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS II)
12 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS-III)
13 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE MICRONIZED AND NON MICRONIZED
14 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE NON-STERILE BULK DRUG SUBSTANCE
15 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE PROCESS II
16 4ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP
17 8ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
18 10ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP
19 3ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP
20 1ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (ROUTE CODE - "ES")
21 2ESOMEPRAZOLE MAGNESIUM USP
22 1ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS)
23 1ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS I)
24 1ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS II)
25 1ESOMEPRAZOLE MAGNESIUM USP (DIHYDRATE) [ROUTE CODE EP]
26 1ESOMEPRAZOLE MAGNESIUM USP (TRIHYDRATE) [ROUTE CODE 'EG']
27 1ESOMEPRAZOLE MAGNESIUM USP, NON-STERILE, BULK DRUG SUBSTANCE
28 1ESOMEPRAZOLE PELLETS 22.5% W/W
29 1ESOMEPRAZOLE POTASSIUM
01 7China
02 2France
03 49India
04 3Italy
05 1Spain
06 3U.S.A
01 57Active
02 8Inactive
01 39Complete
02 26Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28462
Submission : 2014-07-08
Status : Active
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-26
Pay. Date : 2023-04-18
DMF Number : 36556
Submission : 2021-12-24
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35400
Submission : 2020-11-28
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2013-01-16
DMF Number : 23994
Submission : 2010-07-26
Status : Active
Type : II
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-25
Pay. Date : 2019-10-16
DMF Number : 34026
Submission : 2019-10-04
Status : Active
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37233
Submission : 2022-07-01
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35519
Submission : 2020-12-29
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-18
Pay. Date : 2013-01-16
DMF Number : 25858
Submission : 2012-03-30
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2014-04-21
DMF Number : 28127
Submission : 2014-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-04-03
DMF Number : 18821
Submission : 2005-09-28
Status : Active
Type : II
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