01 1Catalent Pharma Solutions
01 1R115866 SOFTGELS
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18708
Submission : 2005-08-26
Status : Inactive
Type : II
A talarozole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of talarozole, including repackagers and relabelers. The FDA regulates talarozole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. talarozole 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 talarozole supplier is an individual or a company that provides talarozole active pharmaceutical ingredient (API) or talarozole finished formulations upon request. The talarozole suppliers may include talarozole API manufacturers, exporters, distributors and traders.
click here to find a list of talarozole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A talarozole DMF (Drug Master File) is a document detailing the whole manufacturing process of talarozole active pharmaceutical ingredient (API) in detail. Different forms of talarozole DMFs exist exist since differing nations have different regulations, such as talarozole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A talarozole DMF submitted to regulatory agencies in the US is known as a USDMF. talarozole USDMF includes data on talarozole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The talarozole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of talarozole suppliers with USDMF on PharmaCompass.
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