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