DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Apothecon Pharmaceuticals
03 1Aurobindo Pharma Limited
04 1GLAND PHARMA LIMITED
05 1Glenmark Life Sciences
06 1Hetero Drugs
07 1Lianyungang Runzhong Pharmaceutical Co Ltd
08 1MSN Laboratories
09 1Piramal Pharma Solutions
10 1Qilu Tianhe Pharmaceutical Co., Ltd.
11 1ScinoPharm Taiwan, Ltd
12 1Viwit Pharmaceuticals Limited
13 2Wisdom Pharmaceutical
14 1Wockhardt
15 1Blank
01 13FOSAPREPITANT DIMEGLUMINE
02 1FOSAPREPITANT DIMEGLUMINE (NON-STERILE API)
03 1FOSAPREPITANT DIMEGLUMINE [ROUTE CODE - "FD"]
04 1FOSAPREPITANT DIMEGLUMINE, NON-STERILE BULK DRUG SUBSTANCE
01 5China
02 8India
03 1Taiwan
04 1U.S.A
05 1Blank
01 15Active
02 1Inactive
01 13Complete
02 3Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-08
Pay. Date : 2023-07-05
DMF Number : 38210
Submission : 2023-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-07
Pay. Date : 2018-09-24
DMF Number : 33105
Submission : 2018-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-17
Pay. Date : 2017-03-15
DMF Number : 31470
Submission : 2017-03-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-04
Pay. Date : 2015-03-17
DMF Number : 28992
Submission : 2015-03-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-03
Pay. Date : 2013-02-01
DMF Number : 25614
Submission : 2011-12-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-20
Pay. Date : 2014-12-18
DMF Number : 28288
Submission : 2014-11-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-16
Pay. Date : 2012-11-23
DMF Number : 25682
Submission : 2012-01-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-20
Pay. Date : 2017-06-15
DMF Number : 31484
Submission : 2017-03-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-20
Pay. Date : 2016-09-22
DMF Number : 30973
Submission : 2017-07-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-25
Pay. Date : 2016-01-14
DMF Number : 30137
Submission : 2015-12-31
Status : Active
Type : II
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