01 1Finar
01 1TERTIARY BUTANOL HIGH PURITY GRADE (HP)
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24710
Submission : 2011-03-04
Status : Active
Type : IV
A Tert-Butanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tert-Butanol, including repackagers and relabelers. The FDA regulates Tert-Butanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tert-Butanol 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 Tert-Butanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tert-Butanol supplier is an individual or a company that provides Tert-Butanol active pharmaceutical ingredient (API) or Tert-Butanol finished formulations upon request. The Tert-Butanol suppliers may include Tert-Butanol API manufacturers, exporters, distributors and traders.
click here to find a list of Tert-Butanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tert-Butanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Tert-Butanol active pharmaceutical ingredient (API) in detail. Different forms of Tert-Butanol DMFs exist exist since differing nations have different regulations, such as Tert-Butanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tert-Butanol DMF submitted to regulatory agencies in the US is known as a USDMF. Tert-Butanol USDMF includes data on Tert-Butanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tert-Butanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tert-Butanol suppliers with USDMF on PharmaCompass.
LOOKING FOR A SUPPLIER?