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
77
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A Thiaben manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thiaben, including repackagers and relabelers. The FDA regulates Thiaben manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thiaben 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 Thiaben manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Thiaben supplier is an individual or a company that provides Thiaben active pharmaceutical ingredient (API) or Thiaben finished formulations upon request. The Thiaben suppliers may include Thiaben API manufacturers, exporters, distributors and traders.
click here to find a list of Thiaben suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Thiaben DMF (Drug Master File) is a document detailing the whole manufacturing process of Thiaben active pharmaceutical ingredient (API) in detail. Different forms of Thiaben DMFs exist exist since differing nations have different regulations, such as Thiaben USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thiaben DMF submitted to regulatory agencies in the US is known as a USDMF. Thiaben USDMF includes data on Thiaben's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thiaben USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thiaben suppliers with USDMF on PharmaCompass.
