01 1SIGMA TAU
01 1THIOPROLINE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3770
Submission : 1980-03-30
Status : Inactive
Type : II
99
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A Heparegene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Heparegene, including repackagers and relabelers. The FDA regulates Heparegene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Heparegene 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 Heparegene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Heparegene supplier is an individual or a company that provides Heparegene active pharmaceutical ingredient (API) or Heparegene finished formulations upon request. The Heparegene suppliers may include Heparegene API manufacturers, exporters, distributors and traders.
click here to find a list of Heparegene suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Heparegene DMF (Drug Master File) is a document detailing the whole manufacturing process of Heparegene active pharmaceutical ingredient (API) in detail. Different forms of Heparegene DMFs exist exist since differing nations have different regulations, such as Heparegene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Heparegene DMF submitted to regulatory agencies in the US is known as a USDMF. Heparegene USDMF includes data on Heparegene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Heparegene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Heparegene suppliers with USDMF on PharmaCompass.
