DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 2TAPI Technology & API Services
03 2Arch Pharmalabs
04 1Archimica
05 1Benzo Chem Industries Pvt
06 1Cipla
07 1Dishman Carbogen Amcis
08 2Emcure Pharmaceuticals
09 1Fresenius Kabi AB Brunna
10 1GLAND CHEMICALS PRIVATE LIMITED
11 2Hansoh Pharma
12 1Hetero Drugs
13 2Intas Pharmaceuticals
14 1JARI Pharmaceutical
15 1Laurus Labs
16 1MSN Laboratories
17 1Olon S.p.A
18 1PharmaEssentia
19 1ScinoPharm Taiwan, Ltd
20 2Shilpa Medicare
21 1Sun Pharmaceutical Industries Limited
22 1Viatris
23 1Yangtze River Pharmaceutical Group
24 1Zhejiang Hisun Pharmaceutical
25 1Zydus Lifesciences
01 7GEMCITABINE HYDROCHLORIDE
02 1GEMCITABINE HYDROCHLORIDE (A-MESYLRIBOSE PROCESS)
03 1GEMCITABINE HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE
04 16GEMCITABINE HYDROCHLORIDE USP
05 1GEMCITABINE HYDROCHLORIDE USP (CODE: GMI)
06 1GEMCITABINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)
07 1GEMCITABINE HYDROCHLORIDE USP (PROCESS -2)
08 1GEMCITABINE HYDROCHLORIDE USP (PROCESS II)
09 1GEMCITABINE HYDROCHLORIDE USP (PROCESS-III)
10 1GEMCITABINE HYDROCHLORIDE USP [ROUTE CODE - "GH"]
01 6China
02 18India
03 2Israel
04 2Italy
05 1Sweden
06 1Taiwan
07 1U.S.A
01 21Active
02 10Inactive
01 13Complete
02 18Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-27
Pay. Date : 2016-06-06
DMF Number : 18857
Submission : 2005-10-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-20
Pay. Date : 2012-12-03
DMF Number : 20979
Submission : 2007-10-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-20
Pay. Date : 2013-08-20
DMF Number : 27402
Submission : 2014-02-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23339
Submission : 2009-12-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-08
Pay. Date : 2012-12-19
DMF Number : 21399
Submission : 2008-04-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22229
Submission : 2008-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22748
Submission : 2009-04-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-16
DMF Number : 22800
Submission : 2009-05-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-11-21
DMF Number : 19053
Submission : 2005-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19427
Submission : 2006-05-16
Status : Active
Type : II
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