01 1Wavelength Pharmaceuticals
02 1Aurisco Pharmaceutical
03 1Curia
04 1Teva Pharmaceutical Industries
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-26
Pay. Date : 2024-05-20
DMF Number : 39935
Submission : 2024-06-06
Status :
Type : II
20
PharmaCompass offers a list of Clascoterone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Clascoterone manufacturer or Clascoterone supplier for your needs.
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A Cortexolone 17alpha-propionate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cortexolone 17alpha-propionate, including repackagers and relabelers. The FDA regulates Cortexolone 17alpha-propionate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cortexolone 17alpha-propionate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Cortexolone 17alpha-propionate supplier is an individual or a company that provides Cortexolone 17alpha-propionate active pharmaceutical ingredient (API) or Cortexolone 17alpha-propionate finished formulations upon request. The Cortexolone 17alpha-propionate suppliers may include Cortexolone 17alpha-propionate API manufacturers, exporters, distributors and traders.
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A Cortexolone 17alpha-propionate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cortexolone 17alpha-propionate active pharmaceutical ingredient (API) in detail. Different forms of Cortexolone 17alpha-propionate DMFs exist exist since differing nations have different regulations, such as Cortexolone 17alpha-propionate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cortexolone 17alpha-propionate DMF submitted to regulatory agencies in the US is known as a USDMF. Cortexolone 17alpha-propionate USDMF includes data on Cortexolone 17alpha-propionate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cortexolone 17alpha-propionate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 4 companies offering Cortexolone 17alpha-propionate
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