01 1BioCryst Pharmaceuticals
01 1BCX-4208 DRUG SUBSTANCE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17583
Submission : 2004-08-03
Status : Inactive
Type : II
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PharmaCompass offers a list of Ulodesine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ulodesine Hydrochloride manufacturer or Ulodesine Hydrochloride supplier for your needs.
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A Ulodesine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ulodesine Hydrochloride, including repackagers and relabelers. The FDA regulates Ulodesine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ulodesine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Ulodesine Hydrochloride supplier is an individual or a company that provides Ulodesine Hydrochloride active pharmaceutical ingredient (API) or Ulodesine Hydrochloride finished formulations upon request. The Ulodesine Hydrochloride suppliers may include Ulodesine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ulodesine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ulodesine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ulodesine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Ulodesine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Ulodesine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ulodesine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ulodesine Hydrochloride USDMF includes data on Ulodesine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ulodesine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ulodesine Hydrochloride suppliers with USDMF on PharmaCompass.
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