01 1Gedeon Richter
01 1CDB-4124
01 1Hungary
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21148
Submission : 2007-12-18
Status : Inactive
Type : II
A Telapristone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Telapristone, including repackagers and relabelers. The FDA regulates Telapristone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Telapristone 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 Telapristone supplier is an individual or a company that provides Telapristone active pharmaceutical ingredient (API) or Telapristone finished formulations upon request. The Telapristone suppliers may include Telapristone API manufacturers, exporters, distributors and traders.
click here to find a list of Telapristone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Telapristone DMF (Drug Master File) is a document detailing the whole manufacturing process of Telapristone active pharmaceutical ingredient (API) in detail. Different forms of Telapristone DMFs exist exist since differing nations have different regulations, such as Telapristone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Telapristone DMF submitted to regulatory agencies in the US is known as a USDMF. Telapristone USDMF includes data on Telapristone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Telapristone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Telapristone suppliers with USDMF on PharmaCompass.
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