01 1Catalytica
01 1BUTAMBEN USP
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11781
Submission : 1995-12-19
Status : Inactive
Type : II
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A Butesin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butesin, including repackagers and relabelers. The FDA regulates Butesin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butesin 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 Butesin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Butesin supplier is an individual or a company that provides Butesin active pharmaceutical ingredient (API) or Butesin finished formulations upon request. The Butesin suppliers may include Butesin API manufacturers, exporters, distributors and traders.
click here to find a list of Butesin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Butesin DMF (Drug Master File) is a document detailing the whole manufacturing process of Butesin active pharmaceutical ingredient (API) in detail. Different forms of Butesin DMFs exist exist since differing nations have different regulations, such as Butesin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butesin DMF submitted to regulatory agencies in the US is known as a USDMF. Butesin USDMF includes data on Butesin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butesin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Butesin suppliers with USDMF on PharmaCompass.
