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 3TAPI Technology & API Services
07 1Actis Generics Pvt Ltd
08 1Almelo
09 1Amoli Organics
10 1Apotex Pharmachem
11 1Aurobindo Pharma Limited
12 1Beijing Huikang Boyuan Chemical Tech
13 3Biocon
14 2Fuxin Long Rui Pharmaceutical
15 3Glenmark Life Sciences
16 1HEC Pharm
17 2HONOUR LAB LTD
18 2Hikal
19 1Jiangsu Baju Pharmaceutical
20 1Jubilant Generics
21 1Laurus Labs
22 2Lee Pharma
23 1Lunan Pharmaceutical
24 1Lupin Ltd
25 5MSN Laboratories
26 1Macleods Pharmaceuticals Limited
27 1Mankind Pharma
28 2Morepen Laboratories
29 1Optimus Pharma
30 1SINTENOVO, S.A. DE C.V.
31 1Sichuan Xieli Pharmaceutical
32 1Signa S.A. de C.V.
33 1Sun Pharmaceutical Industries Limited
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 38Complete
02 28Blank
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
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
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 : 2013-02-12
Pay. Date : 2012-11-13
DMF Number : 25867
Submission : 2012-03-02
Status : Active
Type : II
A Janumet manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Janumet, including repackagers and relabelers. The FDA regulates Janumet manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Janumet API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Janumet manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Janumet supplier is an individual or a company that provides Janumet active pharmaceutical ingredient (API) or Janumet finished formulations upon request. The Janumet suppliers may include Janumet API manufacturers, exporters, distributors and traders.
click here to find a list of Janumet suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Janumet DMF (Drug Master File) is a document detailing the whole manufacturing process of Janumet active pharmaceutical ingredient (API) in detail. Different forms of Janumet DMFs exist exist since differing nations have different regulations, such as Janumet USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Janumet DMF submitted to regulatory agencies in the US is known as a USDMF. Janumet USDMF includes data on Janumet's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Janumet USDMF is kept confidential to protect the manufacturer’s intellectual property.
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