DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories
02 1Wavelength Pharmaceuticals
03 1IOL Chemicals and Pharmaceuticals
04 2Moehs Iberica
05 2Ami Lifesciences Private Limited
06 1Actis Generics Pvt Ltd
07 1Almelo
08 1Amoli Organics
09 1Apotex Pharmachem
10 1Aurobindo Pharma Limited
11 1Beijing Huikang Boyuan Chemical Tech CO.
12 3Biocon
13 2Fuxin Long Rui Pharmaceutical
14 3Glenmark Life Sciences
15 1HEC Pharm
16 2HONOUR LAB LTD
17 2Hikal
18 1Jiangsu Baju Pharmaceutical
19 1Jubilant Generics
20 1Laurus Labs
21 2Lee Pharma
22 1Lunan Pharmaceutical
23 1Lupin Ltd
24 5MSN Laboratories
25 1Macleods Pharmaceuticals Limited
26 1Mankind Pharma
27 2Morepen Laboratories
28 1Optimus Pharma
29 1SINTENOVO, S.A. DE C.V.
30 1Sichuan Xieli Pharmaceutical
31 1Signa S.A. de C.V.
32 1Sun Pharmaceutical Industries Limited
33 3Teva API
34 1Torrent Pharmaceuticals Limited
35 1UQUIFA
36 1Viatris
37 2Viwit Pharmaceuticals Limited
38 1Wockhardt
39 2Zhejiang Apeloa Jiayuan Pharmaceutical
40 1Zhejiang Changming Pharmaceuticals
41 1Zhejiang Huahai Pharmaceutical
42 1Zhejiang Jingsheng Pharmaceutical
43 1Zhejiang Jiuzhou Pharmaceutical
44 1Zhejiang Yongtai Technology
45 2Zydus Lifesciences
01 13-(TRIFLUOROMETHYL)-5,6,7,8-TETRAHYDRO[1,2,4] TRIAZOLO[4,3-A] PYRAZINE HYDROCHLORIDE
02 2SITAGLIPTIN BASE
03 1SITAGLIPTIN FREE BASE
04 12SITAGLIPTIN PHOSPHATE
05 1SITAGLIPTIN PHOSPHATE (MONOHYDRATE)
06 1SITAGLIPTIN PHOSPHATE (NON-STERILE)
07 1SITAGLIPTIN PHOSPHATE ANHYDRATE
08 6SITAGLIPTIN PHOSPHATE ANHYDROUS
09 1SITAGLIPTIN PHOSPHATE ANHYDROUS USP
10 1SITAGLIPTIN PHOSPHATE ANHYDROUS USP [ROUTE CODE - SA]
11 1SITAGLIPTIN PHOSPHATE ANYDROUS
12 1SITAGLIPTIN PHOSPHATE ENZYMATIC
13 13SITAGLIPTIN PHOSPHATE MONOHYDRATE
14 1SITAGLIPTIN PHOSPHATE MONOHYDRATE (PROCESS-B)
15 1SITAGLIPTIN PHOSPHATE MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE
16 9SITAGLIPTIN PHOSPHATE MONOHYDRATE USP
17 1SITAGLIPTIN PHOSPHATE MONOHYDRATE USP (ROUTE CODE SG)
18 9SITAGLIPTIN PHOSPHATE USP
19 1SITAGLIPTIN PHOSPHATE USP (ANHYDROUS)
20 1SITAGLIPTIN PHOSPHATE USP (MONOHYDRATE)
21 1SITAGLIPTIN PHOSPHATE USP (ROUTE-1)
01 1Canada
02 16China
03 39India
04 4Israel
05 2Mexico
06 3Spain
07 1U.S.A
01 61Active
02 5Inactive
01 37Complete
02 29Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-23
Pay. Date : 2019-09-13
DMF Number : 33551
Submission : 2019-01-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-28
Pay. Date : 2024-01-22
DMF Number : 39377
Submission : 2024-02-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38931
Submission : 2024-01-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-15
Pay. Date : 2018-09-20
DMF Number : 33206
Submission : 2018-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37030
Submission : 2022-05-02
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 : 35580
Submission : 2021-02-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-27
Pay. Date : 2023-10-11
DMF Number : 38921
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39354
Submission : 2024-01-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-13
Pay. Date : 2019-08-06
DMF Number : 23864
Submission : 2010-06-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-08
Pay. Date : 2013-01-30
DMF Number : 24067
Submission : 2010-08-16
Status : Active
Type : II
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