01 1Laboratorio Syntex S.A
01 1DROMOSTANOLONE PROPIONATE
01 1Argentina
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 411
Submission : 1960-11-25
Status : Inactive
Type : II
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A Permastril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Permastril, including repackagers and relabelers. The FDA regulates Permastril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Permastril 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 Permastril supplier is an individual or a company that provides Permastril active pharmaceutical ingredient (API) or Permastril finished formulations upon request. The Permastril suppliers may include Permastril API manufacturers, exporters, distributors and traders.
click here to find a list of Permastril suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Permastril DMF (Drug Master File) is a document detailing the whole manufacturing process of Permastril active pharmaceutical ingredient (API) in detail. Different forms of Permastril DMFs exist exist since differing nations have different regulations, such as Permastril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Permastril DMF submitted to regulatory agencies in the US is known as a USDMF. Permastril USDMF includes data on Permastril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Permastril USDMF is kept confidential to protect the manufacturer’s intellectual property.
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