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