01 1Organon
01 1ORGABOLIN TABLETS 2 MG.
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7981
Submission : 1989-02-14
Status : Inactive
Type : II
79
PharmaCompass offers a list of Ethylestrenol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ethylestrenol manufacturer or Ethylestrenol supplier for your needs.
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A Etilestrenol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etilestrenol, including repackagers and relabelers. The FDA regulates Etilestrenol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etilestrenol 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 Etilestrenol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Etilestrenol supplier is an individual or a company that provides Etilestrenol active pharmaceutical ingredient (API) or Etilestrenol finished formulations upon request. The Etilestrenol suppliers may include Etilestrenol API manufacturers, exporters, distributors and traders.
click here to find a list of Etilestrenol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Etilestrenol DMF (Drug Master File) is a document detailing the whole manufacturing process of Etilestrenol active pharmaceutical ingredient (API) in detail. Different forms of Etilestrenol DMFs exist exist since differing nations have different regulations, such as Etilestrenol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Etilestrenol DMF submitted to regulatory agencies in the US is known as a USDMF. Etilestrenol USDMF includes data on Etilestrenol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Etilestrenol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Etilestrenol suppliers with USDMF on PharmaCompass.
