Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 4Dr. Reddy's Laboratories
03 1Metrochem API Private Limited
04 1Cohance Lifesciences
05 1Aarti Pharmalabs
06 1Ami Lifesciences Private Limited
07 1USV Private Limited
08 1Granules India Limited
09 1TAPI Technology & API Services
10 1Beijing Mesochem Technology
11 1ALP Pharm
12 1Alembic Pharmaceuticals Limited
13 1Aurobindo Pharma Limited
14 1Beijing Huikang Boyuan Chemical Tech
15 1Biocon
16 1CHEMO SMS ENTERPRISE SL
17 1Cipla
18 1Emnar Pharma
19 1Fuxin Long Rui Pharmaceutical
20 2HONOUR LAB LTD
21 1Hangzhou Huadong Medicine Group Kangrun Pharmaceutical
22 1Hikal
23 1Jiangxi Synergy Pharmaceutical
24 1Laurus Labs
25 1Lee Pharma
26 1Lupin Ltd
27 2MSN Laboratories
28 1Macleods Pharmaceuticals Limited
29 1Morepen Laboratories
30 1Optimus Pharma
31 1Piramal Pharma Solutions
32 1Sichuan Kelun Pharmaceutical
33 1Sun Pharmaceutical Industries Limited
34 1Viatris
35 1ZHEJIANG HONGYUAN PHARMACEUTICAL CO. - LTD
36 1ZHEJIANG LANGHUA PHARMACEUTICAL
37 2Zhejiang Huahai Pharmaceutical
38 1Zhejiang Jingsheng Pharmaceutical
39 1Zydus Lifesciences
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-15
Pay. Date : 2018-10-09
DMF Number : 33180
Submission : 2018-09-27
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 : 32349
Submission : 2018-01-02
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35345
Submission : 2020-10-31
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36944
Submission : 2022-07-12
Status :
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32379
Submission : 2017-12-21
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38200
Submission : 2023-03-29
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-14
Pay. Date : 2023-12-28
DMF Number : 39318
Submission : 2023-12-30
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39521
Submission : 2024-03-29
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 : 2018-11-29
Pay. Date : 2018-07-27
DMF Number : 32421
Submission : 2018-09-17
Status :
Type : II
Mesochem is focused on incessant innovation along with the R&D of new APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33313
Submission : 2018-11-07
Status :
Type : II
A JARDIANCE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of JARDIANCE, including repackagers and relabelers. The FDA regulates JARDIANCE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. JARDIANCE 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 JARDIANCE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A JARDIANCE supplier is an individual or a company that provides JARDIANCE active pharmaceutical ingredient (API) or JARDIANCE finished formulations upon request. The JARDIANCE suppliers may include JARDIANCE API manufacturers, exporters, distributors and traders.
click here to find a list of JARDIANCE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A JARDIANCE DMF (Drug Master File) is a document detailing the whole manufacturing process of JARDIANCE active pharmaceutical ingredient (API) in detail. Different forms of JARDIANCE DMFs exist exist since differing nations have different regulations, such as JARDIANCE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A JARDIANCE DMF submitted to regulatory agencies in the US is known as a USDMF. JARDIANCE USDMF includes data on JARDIANCE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The JARDIANCE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of JARDIANCE suppliers with USDMF on PharmaCompass.
We have 39 companies offering JARDIANCE
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