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 offers customized CDMO Solutions for API development and manufacturing services.
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 Malate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sunitinib Malate, including repackagers and relabelers. The FDA regulates Sunitinib Malate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sunitinib Malate 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 Malate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sunitinib Malate supplier is an individual or a company that provides Sunitinib Malate active pharmaceutical ingredient (API) or Sunitinib Malate finished formulations upon request. The Sunitinib Malate suppliers may include Sunitinib Malate API manufacturers, exporters, distributors and traders.
click here to find a list of Sunitinib Malate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sunitinib Malate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sunitinib Malate active pharmaceutical ingredient (API) in detail. Different forms of Sunitinib Malate DMFs exist exist since differing nations have different regulations, such as Sunitinib Malate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sunitinib Malate DMF submitted to regulatory agencies in the US is known as a USDMF. Sunitinib Malate USDMF includes data on Sunitinib Malate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sunitinib Malate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sunitinib Malate suppliers with USDMF on PharmaCompass.
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