01 1Wavelength Pharmaceuticals
02 1IOL Chemicals and Pharmaceuticals
03 2Moehs Iberica
04 2Ami Lifesciences Private Limited
05 1Actis Generics Pvt Ltd
06 1Almelo
07 1Amoli Organics
08 1Apotex Pharmachem
09 1Aurobindo Pharma Limited
10 1Beijing Huikang Boyuan Chemical Tech CO.
11 3Biocon
12 2Fuxin Long Rui Pharmaceutical
13 3Glenmark Life Sciences
14 1HEC Pharm
15 2HONOUR LAB LTD
16 2Hikal
17 1Jubilant Generics
18 1Laurus Labs
19 2Lee Pharma
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22 5MSN Laboratories
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24 1Mankind Pharma
25 2Morepen Laboratories
26 1Optimus Pharma
27 1SINTENOVO, S.A. DE C.V.
28 1Sichuan Xieli Pharmaceutical
29 1Signa S.A. de C.V.
30 1Sun Pharmaceutical Industries Limited
31 3Teva API
32 1Torrent Pharmaceuticals Limited
33 1UQUIFA
34 1Viatris
35 2Viwit Pharmaceuticals Limited
36 1Wockhardt
37 2Zhejiang Apeloa Jiayuan Pharmaceutical
38 1Zhejiang Changming Pharmaceuticals
39 1Zhejiang Huahai Pharmaceutical
40 1Zhejiang Jingsheng Pharmaceutical
41 1Zhejiang Jiuzhou Pharmaceutical
42 2Zhejiang Yongtai Technology
43 2Zydus Lifesciences
01 13-(TRIFLUOROMETHYL)-5,6,7,8-TETRAHYDRO[1,2,4] TRIAZOLO[4,3-A] PYRAZINE HYDROCHLORIDE
02 1INTERMEDIATE OF SITAGLIPTIN PHOSPHATE (3R)-N-(TERT-BUTOXYCARBONYL)-3-AMINO-4-(2,4,5-TRIFLUOROPHENYL) BUTANOIC ACID)
03 1SITAGLIPTIN BASE
04 1SITAGLIPTIN FREE BASE
05 12SITAGLIPTIN PHOSPHATE
06 1SITAGLIPTIN PHOSPHATE (MONOHYDRATE)
07 1SITAGLIPTIN PHOSPHATE (NON-STERILE)
08 1SITAGLIPTIN PHOSPHATE ANHYDRATE
09 6SITAGLIPTIN PHOSPHATE ANHYDROUS
10 1SITAGLIPTIN PHOSPHATE ANHYDROUS USP
11 1SITAGLIPTIN PHOSPHATE ANHYDROUS USP [ROUTE CODE - SA]
12 1SITAGLIPTIN PHOSPHATE ANYDROUS
13 1SITAGLIPTIN PHOSPHATE ENZYMATIC
14 13SITAGLIPTIN PHOSPHATE MONOHYDRATE
15 1SITAGLIPTIN PHOSPHATE MONOHYDRATE (PROCESS-B)
16 1SITAGLIPTIN PHOSPHATE MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE
17 9SITAGLIPTIN PHOSPHATE MONOHYDRATE USP
18 1SITAGLIPTIN PHOSPHATE MONOHYDRATE USP (ROUTE CODE SG)
19 9SITAGLIPTIN PHOSPHATE USP
20 1SITAGLIPTIN PHOSPHATE USP (ROUTE-1)
01 1Canada
02 16China
03 37India
04 4Israel
05 2Mexico
06 3Spain
07 1U.S.A
01 59Active
02 5Inactive
01 36Complete
02 28Blank
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
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 : 2013-01-24
Pay. Date : 2012-11-23
DMF Number : 24199
Submission : 2010-10-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 24148
Submission : 2010-09-09
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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