01 1Opocrin SpA
01 1SULODEXIDE
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14874
Submission : 2000-05-10
Status : Inactive
Type : II
A Sulodexide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulodexide, including repackagers and relabelers. The FDA regulates Sulodexide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulodexide 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 Sulodexide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulodexide supplier is an individual or a company that provides Sulodexide active pharmaceutical ingredient (API) or Sulodexide finished formulations upon request. The Sulodexide suppliers may include Sulodexide API manufacturers, exporters, distributors and traders.
click here to find a list of Sulodexide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulodexide DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulodexide active pharmaceutical ingredient (API) in detail. Different forms of Sulodexide DMFs exist exist since differing nations have different regulations, such as Sulodexide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulodexide DMF submitted to regulatory agencies in the US is known as a USDMF. Sulodexide USDMF includes data on Sulodexide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulodexide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulodexide suppliers with USDMF on PharmaCompass.
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