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