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