01 1CHEMSPEC CHEMICALS PVT LTD
01 1TRICLOCARBAN
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25060
Submission : 2011-06-14
Status : Inactive
Type : II
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A Solubacter manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solubacter, including repackagers and relabelers. The FDA regulates Solubacter manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solubacter 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 Solubacter supplier is an individual or a company that provides Solubacter active pharmaceutical ingredient (API) or Solubacter finished formulations upon request. The Solubacter suppliers may include Solubacter API manufacturers, exporters, distributors and traders.
click here to find a list of Solubacter suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Solubacter DMF (Drug Master File) is a document detailing the whole manufacturing process of Solubacter active pharmaceutical ingredient (API) in detail. Different forms of Solubacter DMFs exist exist since differing nations have different regulations, such as Solubacter USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Solubacter DMF submitted to regulatory agencies in the US is known as a USDMF. Solubacter USDMF includes data on Solubacter's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Solubacter USDMF is kept confidential to protect the manufacturer’s intellectual property.
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