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 1Astellas Pharma
04 1Biocon
05 1BrightGene Bio-Medical Technology Co.,Ltd
06 2Hansoh Pharma
07 1Hetero Drugs
08 1MSN Laboratories
09 1Shanghai Techwell Biopharma
10 1Yung Shin Pharmaceutical Industrial
11 1Zhejiang Hisun Pharmaceutical
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-20
Pay. Date : 2016-06-02
DMF Number : 30558
Submission : 2016-06-06
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 : 2018-10-29
Pay. Date : 2018-05-14
DMF Number : 32812
Submission : 2018-06-17
Status :
Type : II
A Micafungin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Micafungin, including repackagers and relabelers. The FDA regulates Micafungin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Micafungin 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 Micafungin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Micafungin supplier is an individual or a company that provides Micafungin active pharmaceutical ingredient (API) or Micafungin finished formulations upon request. The Micafungin suppliers may include Micafungin API manufacturers, exporters, distributors and traders.
click here to find a list of Micafungin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Micafungin DMF (Drug Master File) is a document detailing the whole manufacturing process of Micafungin active pharmaceutical ingredient (API) in detail. Different forms of Micafungin DMFs exist exist since differing nations have different regulations, such as Micafungin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Micafungin DMF submitted to regulatory agencies in the US is known as a USDMF. Micafungin USDMF includes data on Micafungin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Micafungin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Micafungin suppliers with USDMF on PharmaCompass.
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