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 T201 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of T201, including repackagers and relabelers. The FDA regulates T201 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. T201 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 T201 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A T201 supplier is an individual or a company that provides T201 active pharmaceutical ingredient (API) or T201 finished formulations upon request. The T201 suppliers may include T201 API manufacturers, exporters, distributors and traders.
click here to find a list of T201 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A T201 DMF (Drug Master File) is a document detailing the whole manufacturing process of T201 active pharmaceutical ingredient (API) in detail. Different forms of T201 DMFs exist exist since differing nations have different regulations, such as T201 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A T201 DMF submitted to regulatory agencies in the US is known as a USDMF. T201 USDMF includes data on T201's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The T201 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of T201 suppliers with USDMF on PharmaCompass.
