PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
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PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15258
Submission : 2001-01-23
Status : Active
Type : II
A Fosetyl-Al manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosetyl-Al, including repackagers and relabelers. The FDA regulates Fosetyl-Al manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosetyl-Al 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 Fosetyl-Al supplier is an individual or a company that provides Fosetyl-Al active pharmaceutical ingredient (API) or Fosetyl-Al finished formulations upon request. The Fosetyl-Al suppliers may include Fosetyl-Al API manufacturers, exporters, distributors and traders.
click here to find a list of Fosetyl-Al suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosetyl-Al DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosetyl-Al active pharmaceutical ingredient (API) in detail. Different forms of Fosetyl-Al DMFs exist exist since differing nations have different regulations, such as Fosetyl-Al USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosetyl-Al DMF submitted to regulatory agencies in the US is known as a USDMF. Fosetyl-Al USDMF includes data on Fosetyl-Al's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosetyl-Al USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosetyl-Al suppliers with USDMF on PharmaCompass.
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