01 1SAFC
01 1PERCORTEN PIVALATE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9977
Submission : 1992-11-18
Status : Inactive
Type : II
A Percorten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Percorten, including repackagers and relabelers. The FDA regulates Percorten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Percorten 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 Percorten manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Percorten supplier is an individual or a company that provides Percorten active pharmaceutical ingredient (API) or Percorten finished formulations upon request. The Percorten suppliers may include Percorten API manufacturers, exporters, distributors and traders.
click here to find a list of Percorten suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Percorten DMF (Drug Master File) is a document detailing the whole manufacturing process of Percorten active pharmaceutical ingredient (API) in detail. Different forms of Percorten DMFs exist exist since differing nations have different regulations, such as Percorten USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Percorten DMF submitted to regulatory agencies in the US is known as a USDMF. Percorten USDMF includes data on Percorten's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Percorten USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Percorten suppliers with USDMF on PharmaCompass.
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