01 1Unichem Laboratories Limited
01 1THIACETAZONE
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5661
Submission : 1984-11-06
Status : Inactive
Type : II
A Thioacetazone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thioacetazone, including repackagers and relabelers. The FDA regulates Thioacetazone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thioacetazone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Thioacetazone supplier is an individual or a company that provides Thioacetazone active pharmaceutical ingredient (API) or Thioacetazone finished formulations upon request. The Thioacetazone suppliers may include Thioacetazone API manufacturers, exporters, distributors and traders.
click here to find a list of Thioacetazone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thioacetazone DMF (Drug Master File) is a document detailing the whole manufacturing process of Thioacetazone active pharmaceutical ingredient (API) in detail. Different forms of Thioacetazone DMFs exist exist since differing nations have different regulations, such as Thioacetazone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thioacetazone DMF submitted to regulatory agencies in the US is known as a USDMF. Thioacetazone USDMF includes data on Thioacetazone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thioacetazone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thioacetazone suppliers with USDMF on PharmaCompass.
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