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01 1DROLOXIFENE CITRATE IN TABLET DOSAGE FORM
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8596
Submission : 1990-06-15
Status : Inactive
Type : II
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A Droloxifene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Droloxifene, including repackagers and relabelers. The FDA regulates Droloxifene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Droloxifene 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 Droloxifene supplier is an individual or a company that provides Droloxifene active pharmaceutical ingredient (API) or Droloxifene finished formulations upon request. The Droloxifene suppliers may include Droloxifene API manufacturers, exporters, distributors and traders.
click here to find a list of Droloxifene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Droloxifene DMF (Drug Master File) is a document detailing the whole manufacturing process of Droloxifene active pharmaceutical ingredient (API) in detail. Different forms of Droloxifene DMFs exist exist since differing nations have different regulations, such as Droloxifene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Droloxifene DMF submitted to regulatory agencies in the US is known as a USDMF. Droloxifene USDMF includes data on Droloxifene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Droloxifene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Droloxifene suppliers with USDMF on PharmaCompass.
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