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