ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1TAPI Technology & API Services
03 1Concord Biotech
04 1Hubei Honch Pharmaceutical
05 1Kyowa Hakko Bio
06 1Wuxi Fortune Pharmaceutical Co., Ltd
07 2Zhejiang Hisun Pharmaceutical
08 1Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33811
Submission : 2019-11-04
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-09
DMF Number : 13791
Submission : 1998-09-01
Status :
Type : II
A Mitomycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitomycin, including repackagers and relabelers. The FDA regulates Mitomycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitomycin 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 Mitomycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitomycin supplier is an individual or a company that provides Mitomycin active pharmaceutical ingredient (API) or Mitomycin finished formulations upon request. The Mitomycin suppliers may include Mitomycin API manufacturers, exporters, distributors and traders.
click here to find a list of Mitomycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mitomycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Mitomycin active pharmaceutical ingredient (API) in detail. Different forms of Mitomycin DMFs exist exist since differing nations have different regulations, such as Mitomycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mitomycin DMF submitted to regulatory agencies in the US is known as a USDMF. Mitomycin USDMF includes data on Mitomycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mitomycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mitomycin suppliers with USDMF on PharmaCompass.
We have 7 companies offering Mitomycin
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