Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1TAPI Technology & API Services
03 1Cdymax
04 1Hetero Drugs
05 1Hikma Pharmaceuticals
06 1MSN Laboratories
07 1Reliance Life Sciences Private Limited
08 2Shilpa Medicare
09 1Sichuan Xieli Pharmaceutical
10 1Sun Pharmaceutical Industries Limited
11 1Viatris
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-11
Pay. Date : 2016-06-02
DMF Number : 30559
Submission : 2016-06-03
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 : 23414
Submission : 2009-12-29
Status :
Type : II
A Sunitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sunitinib, including repackagers and relabelers. The FDA regulates Sunitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sunitinib 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 Sunitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sunitinib supplier is an individual or a company that provides Sunitinib active pharmaceutical ingredient (API) or Sunitinib finished formulations upon request. The Sunitinib suppliers may include Sunitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Sunitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sunitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Sunitinib active pharmaceutical ingredient (API) in detail. Different forms of Sunitinib DMFs exist exist since differing nations have different regulations, such as Sunitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sunitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Sunitinib USDMF includes data on Sunitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sunitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sunitinib suppliers with USDMF on PharmaCompass.
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