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