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