01 1Merck & Co
01 1THIABENDAZOLE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 551
Submission : 1963-04-19
Status : Inactive
Type : II
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A Thibenzole att manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thibenzole att, including repackagers and relabelers. The FDA regulates Thibenzole att manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thibenzole att API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Thibenzole att supplier is an individual or a company that provides Thibenzole att active pharmaceutical ingredient (API) or Thibenzole att finished formulations upon request. The Thibenzole att suppliers may include Thibenzole att API manufacturers, exporters, distributors and traders.
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A Thibenzole att DMF (Drug Master File) is a document detailing the whole manufacturing process of Thibenzole att active pharmaceutical ingredient (API) in detail. Different forms of Thibenzole att DMFs exist exist since differing nations have different regulations, such as Thibenzole att USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thibenzole att DMF submitted to regulatory agencies in the US is known as a USDMF. Thibenzole att USDMF includes data on Thibenzole att's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thibenzole att USDMF is kept confidential to protect the manufacturer’s intellectual property.
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