01 1RP SCHERER GMBH & CO. KG
01 1OXYPHENBUTAZONE CAPSULE 100MG
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1924
Submission : 1972-05-01
Status : Inactive
Type : II
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A Reozon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Reozon, including repackagers and relabelers. The FDA regulates Reozon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Reozon 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 Reozon supplier is an individual or a company that provides Reozon active pharmaceutical ingredient (API) or Reozon finished formulations upon request. The Reozon suppliers may include Reozon API manufacturers, exporters, distributors and traders.
click here to find a list of Reozon suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Reozon DMF (Drug Master File) is a document detailing the whole manufacturing process of Reozon active pharmaceutical ingredient (API) in detail. Different forms of Reozon DMFs exist exist since differing nations have different regulations, such as Reozon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Reozon DMF submitted to regulatory agencies in the US is known as a USDMF. Reozon USDMF includes data on Reozon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Reozon USDMF is kept confidential to protect the manufacturer’s intellectual property.
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