DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories
02 1Alembic Pharmaceuticals Limited
03 1Almelo
04 1Anjan Drug Private Limited
05 1Aurisco Pharmaceutical
06 1Aurobindo Pharma Limited
07 1CTX Lifesciences
08 2Changzhou Pharmaceutical Factory
09 1Chromo Laboratories
10 1Cipla
11 2Divis Laboratories
12 1Glenmark Life Sciences
13 1Hetero Drugs
14 2Hikal
15 1Huanggang LUBAN Pharmaceutical
16 1Innovare Labs
17 2Intas Pharmaceuticals
18 2Kopran
19 1LONZEAL PHARMACEUTICALS CO LTD
20 1Laboratorio Chimico Internazionale Spa
21 1Laurus Labs
22 2Lupin Ltd
23 3MSN Laboratories
24 1Macleods Pharmaceuticals Limited
25 2Optimus Pharma
26 1Piramal Pharma Solutions
27 1Solara Active Pharma Sciences
28 1Srini Pharmaceuticals
29 1Sun Pharmaceutical Industries Limited
30 2TAPI Technology & API Services
31 1Vasudha Pharma Chem
32 3Viatris
33 1Wanbury Limited
34 1Zhejiang Apeloa Jiayuan Pharmaceutical
35 1Zhejiang Bamboo Pharmaceuticals
36 1Zhejiang Huahai Pharmaceutical
37 1Zhejiang Jiuzhou Pharmaceutical
38 3Zydus Lifesciences
01 1(S)-PREGABALIN
02 13-(2-AMINO-2-OXOETHYL)-5-METHYLHEXANOIC ACID
03 19PREGABALIN
04 1PREGABALIN (ALTERNATIVE PROCESS)
05 1PREGABALIN (PROCESS II)
06 1PREGABALIN (PROCESS-B) USP
07 1PREGABALIN (PROCESS-II)
08 1PREGABALIN (ROUTE CODE - "OP-PGN")
09 1PREGABALIN (ROUTE CODE:PR)
10 1PREGABALIN D9333
11 1PREGABALIN DRUG SUBSTANCE
12 17PREGABALIN USP
13 1PREGABALIN USP (NON-STERILE DRUG SUBSTANCE)
14 1PREGABALIN USP (PGC ROUTE)
15 1PREGABALIN USP (PROCESS II)
16 1PREGABALIN USP (PROCESS-II)
17 1PREGABALIN USP [ROUTE CODE - "PU"]
18 1PREGABALIN USP [ROUTE CODE - PB"]
19 1PREGBALIN USP
01 9China
02 37India
03 2Israel
04 1Italy
05 4U.S.A
01 43Active
02 10Inactive
01 29Complete
02 24Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-01
Pay. Date : 2016-07-14
DMF Number : 30663
Submission : 2016-06-28
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35314
Submission : 2021-04-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-06
Pay. Date : 2015-01-29
DMF Number : 24292
Submission : 2010-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-07
Pay. Date : 2013-09-27
DMF Number : 22223
Submission : 2008-11-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24196
Submission : 2010-09-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22330
Submission : 2008-12-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-10-06
DMF Number : 22111
Submission : 2008-10-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22128
Submission : 2008-11-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 22242
Submission : 2008-12-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-01
Pay. Date : 2016-03-24
DMF Number : 22485
Submission : 2009-02-03
Status : Active
Type : II
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