Minakem is manufacturing small molecules APIs including corticosteroids
01 1Minakem (formerly Delmar Chemicals)
02 1Dr. Reddy's Laboratories
03 2TAPI Technology & API Services
04 1Apotex Pharmachem
05 1Aurobindo Pharma Limited
06 1China Gateway Pharmaceutical Co Ltd
07 1Cipla
08 1Formosa Laboratories
09 1Hetero Drugs
10 1LG Life Sciences
11 1Laurus Labs
12 1Linhai Huanan Chemicals Co., Ltd.
13 1Lunan Pharmaceutical
14 3MSN Laboratories
15 1Macleods Pharmaceuticals Limited
16 1Melody Healthcare Pvt Ltd
17 1Morepen Laboratories
18 1SINTENOVO, S.A. DE C.V.
19 1Sun Pharmaceutical Industries Limited
20 1Torrent Pharmaceuticals Limited
21 1Unichem Laboratories Limited
22 5Unimark Remedies Limited
23 1Viatris
24 1Zenfold Sustainable Technologies
25 2Zhejiang Tianyu Pharmaceutical Co., Ltd
01 2MONTELUKAST BACKONE DIOL
02 13MONTELUKAST SODIUM
03 1MONTELUKAST SODIUM (NI)
04 1MONTELUKAST SODIUM (PROCESS A)
05 1MONTELUKAST SODIUM (PROCESS B)
06 1MONTELUKAST SODIUM THIOL ACID
07 8MONTELUKAST SODIUM USP
08 1MONTELUKAST SODIUM USP (NON-STERILE DRUG SUBSTANCE)
09 1MONTELUKAST SODIUM USP (PROCESS-C)
10 1MONTELUKAST SODIUM USP [ROUTE CODE - "MB"]
11 1MONTELUKAST SODIUM USP [ROUTE CODE - "MK"]
12 1MONTELUKAST SODIUM USP [ROUTE CODE - MT"]
13 1MONTELUKAST SODIUM [PROCESS-2]
01 2Canada
02 5China
03 20India
04 2Israel
05 1Mexico
06 1South Korea
07 1Taiwan
08 1U.S.A
01 24Active
02 9Inactive
01 14Complete
02 19Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16243
Submission : 2002-11-15
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 : 2015-02-18
Pay. Date : 2012-12-31
DMF Number : 24516
Submission : 2010-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19829
Submission : 2006-10-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-20
Pay. Date : 2017-02-22
DMF Number : 31413
Submission : 2017-05-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23495
Submission : 2010-01-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-22
Pay. Date : 2012-12-03
DMF Number : 21702
Submission : 2008-06-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-24
Pay. Date : 2017-03-13
DMF Number : 23736
Submission : 2010-04-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-04
Pay. Date : 2015-04-29
DMF Number : 20580
Submission : 2007-06-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-11-12
DMF Number : 22484
Submission : 2009-02-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-11
Pay. Date : 2013-06-26
DMF Number : 20425
Submission : 2007-03-26
Status : Active
Type : II
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