01 1Gattefosse
01 1COMPRITOL 888 PELLETS, COMPRITOL 888 ATO
01 1France
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4663
Submission : 1982-09-16
Status : Active
Type : IV
A Tribehenin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tribehenin, including repackagers and relabelers. The FDA regulates Tribehenin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tribehenin 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 Tribehenin supplier is an individual or a company that provides Tribehenin active pharmaceutical ingredient (API) or Tribehenin finished formulations upon request. The Tribehenin suppliers may include Tribehenin API manufacturers, exporters, distributors and traders.
click here to find a list of Tribehenin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tribehenin DMF (Drug Master File) is a document detailing the whole manufacturing process of Tribehenin active pharmaceutical ingredient (API) in detail. Different forms of Tribehenin DMFs exist exist since differing nations have different regulations, such as Tribehenin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tribehenin DMF submitted to regulatory agencies in the US is known as a USDMF. Tribehenin USDMF includes data on Tribehenin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tribehenin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tribehenin suppliers with USDMF on PharmaCompass.
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