01 1Siegfried AG
01 1PHOLCODINE - MFR' & SPECS
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 343
Submission : 1959-08-18
Status : Inactive
Type : II
A Pholcodine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pholcodine, including repackagers and relabelers. The FDA regulates Pholcodine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pholcodine 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 Pholcodine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pholcodine supplier is an individual or a company that provides Pholcodine active pharmaceutical ingredient (API) or Pholcodine finished formulations upon request. The Pholcodine suppliers may include Pholcodine API manufacturers, exporters, distributors and traders.
click here to find a list of Pholcodine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pholcodine DMF (Drug Master File) is a document detailing the whole manufacturing process of Pholcodine active pharmaceutical ingredient (API) in detail. Different forms of Pholcodine DMFs exist exist since differing nations have different regulations, such as Pholcodine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pholcodine DMF submitted to regulatory agencies in the US is known as a USDMF. Pholcodine USDMF includes data on Pholcodine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pholcodine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pholcodine suppliers with USDMF on PharmaCompass.
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