01 1ACS DOBFAR SPA
02 1Pfizer Inc
01 1MEDRYSONE
02 1MEDRYSONE USP XIX, NON-MICRONIZED AND MICRONIZED
01 1Italy
02 1U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3104
Submission : 1977-12-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1535
Submission : 1970-06-11
Status : Inactive
Type : II
A Medrysone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Medrysone, including repackagers and relabelers. The FDA regulates Medrysone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Medrysone 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 Medrysone supplier is an individual or a company that provides Medrysone active pharmaceutical ingredient (API) or Medrysone finished formulations upon request. The Medrysone suppliers may include Medrysone API manufacturers, exporters, distributors and traders.
click here to find a list of Medrysone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Medrysone DMF (Drug Master File) is a document detailing the whole manufacturing process of Medrysone active pharmaceutical ingredient (API) in detail. Different forms of Medrysone DMFs exist exist since differing nations have different regulations, such as Medrysone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Medrysone DMF submitted to regulatory agencies in the US is known as a USDMF. Medrysone USDMF includes data on Medrysone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Medrysone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Medrysone suppliers with USDMF on PharmaCompass.
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