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