DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1TAPI Technology & API Services
03 1Apotex Pharmachem
04 1Aurobindo Pharma Limited
05 1Hetero Drugs
06 1Hospira, Inc.
07 2KYORIN PHARMACEUTICAL CO LTD
08 1Lupin Ltd
09 1Signa S.A. de C.V.
10 1UQUIFA
11 1Viatris
12 2Zydus Lifesciences
01 4GATIFLOXACIN
02 2GATIFLOXACIN ANHYDROUS
03 1GATIFLOXACIN DRUG SUBSTANCE
04 4GATIFLOXACIN HEMIHYDRATE
05 1GATIFLOXACIN HEMIHYDRATE (NON-STERILE DRUG SUBSTANCE)
06 1GATIFLOXACIN SESQUIHYDRATE
07 1TEQUIN I.V. (GATIFLOXACIN)
01 1Canada
02 6India
03 1Israel
04 2Japan
05 1Mexico
06 1Spain
07 2U.S.A
01 6Active
02 8Inactive
01 3Complete
02 11Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-01
Pay. Date : 2019-01-28
DMF Number : 17012
Submission : 2003-12-02
Status : Active
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16965
Submission : 2003-11-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20685
Submission : 2007-07-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-14
Pay. Date : 2013-09-03
DMF Number : 26452
Submission : 2012-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13905
Submission : 1998-12-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15597
Submission : 2001-08-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13902
Submission : 1998-12-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23552
Submission : 2010-04-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-30
Pay. Date : 2013-04-12
DMF Number : 17013
Submission : 2003-12-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17002
Submission : 2003-12-03
Status : Inactive
Type : II
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