01 1RP SCHERER GMBH & CO. KG
01 1ENPROSTIL CAPSULES
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5737
Submission : 1985-02-12
Status : Inactive
Type : II
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A Gardrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gardrine, including repackagers and relabelers. The FDA regulates Gardrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gardrine 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 Gardrine supplier is an individual or a company that provides Gardrine active pharmaceutical ingredient (API) or Gardrine finished formulations upon request. The Gardrine suppliers may include Gardrine API manufacturers, exporters, distributors and traders.
click here to find a list of Gardrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Gardrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Gardrine active pharmaceutical ingredient (API) in detail. Different forms of Gardrine DMFs exist exist since differing nations have different regulations, such as Gardrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gardrine DMF submitted to regulatory agencies in the US is known as a USDMF. Gardrine USDMF includes data on Gardrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gardrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gardrine suppliers with USDMF on PharmaCompass.
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