DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 3Dr. 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 1Mankind Pharma
08 1Actis Generics Pvt Ltd
09 3Alivus Life Sciences
10 1Almelo
11 1Amoli Organics
12 1Apotex Pharmachem
13 1Aurobindo Pharma Limited
14 1Beijing Huikang Boyuan Chemical Tech
15 3Biocon
16 1CHEMO
17 1Chromo Laboratories
18 2Fuxin Long Rui Pharmaceutical
19 2HEC Pharm
20 2Hikal
21 2Honour Lab
22 1Jiangsu Baju Pharmaceutical
23 1Jubilant Generics
24 1Laurus Labs
25 2Lee Pharma
26 1Lunan Pharmaceutical
27 1Lupin Ltd
28 5MSN Laboratories
29 1Macleods Pharmaceuticals Limited
30 2Morepen Laboratories
31 1Optimus Pharma
32 1SINTENOVO, S.A. DE C.V.
33 1Sichuan Xieli Pharmaceutical
34 1Signa S.A. de C.V.
35 1Sun Pharmaceutical Industries Limited
36 1Torrent Pharmaceuticals Limited
37 1UQUIFA
38 1Viatris
39 2Viwit Pharmaceuticals Limited
40 1Wockhardt
41 2Zhejiang Apeloa Jiayuan Pharmaceutical
42 1Zhejiang Changming Pharmaceuticals
43 1Zhejiang Huahai Pharmaceutical
44 1Zhejiang Jingsheng Pharmaceutical
45 1Zhejiang Jiuzhou Pharmaceutical
46 1Zhejiang Yongtai Technology
47 2Zydus Lifesciences
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 :
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-28
Pay. Date : 2024-01-22
DMF Number : 39377
Submission : 2024-02-02
Status :
Type : II
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38931
Submission : 2024-01-31
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-15
Pay. Date : 2018-09-20
DMF Number : 33206
Submission : 2018-09-28
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37030
Submission : 2022-05-02
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 24148
Submission : 2010-09-09
Status :
Type : II
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-18
Pay. Date : 2021-09-08
DMF Number : 35702
Submission : 2021-03-31
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-26
Pay. Date : 2024-12-11
DMF Number : 40524
Submission : 2024-09-27
Status :
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 :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-27
Pay. Date : 2023-10-11
DMF Number : 38921
Submission : 2023-09-28
Status :
Type : II
22
PharmaCompass offers a list of Sitagliptin Phosphate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sitagliptin Phosphate manufacturer or Sitagliptin Phosphate supplier for your needs.
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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.
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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.
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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.
click here to find a list of Janumet suppliers with USDMF on PharmaCompass.
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