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