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