Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech
02 1Aurobindo Pharma Limited
03 1MSN Laboratories
04 1Nanjing Pharmaceutical
05 1Wisdom Pharmaceutical
06 1Blank
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36030
Submission : 2021-08-04
Status :
Type : II
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PharmaCompass offers a list of Baricitinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Baricitinib manufacturer or Baricitinib supplier for your needs.
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A Baricitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Baricitinib, including repackagers and relabelers. The FDA regulates Baricitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Baricitinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Baricitinib supplier is an individual or a company that provides Baricitinib active pharmaceutical ingredient (API) or Baricitinib finished formulations upon request. The Baricitinib suppliers may include Baricitinib API manufacturers, exporters, distributors and traders.
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A Baricitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Baricitinib active pharmaceutical ingredient (API) in detail. Different forms of Baricitinib DMFs exist exist since differing nations have different regulations, such as Baricitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Baricitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Baricitinib USDMF includes data on Baricitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Baricitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
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