01 1Helsinn Advanced Synthesis
02 1Maithri Drugs
03 1Olon S.p.A
04 1Taro Pharmaceutical Industries
01 4TRIFAROTENE
01 1India
02 1Italy
03 1Switzerland
04 1U.S.A
01 4Active
01 2Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32486
Submission : 2018-07-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38337
Submission : 2023-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-19
Pay. Date : 2022-05-31
DMF Number : 37099
Submission : 2022-05-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-19
Pay. Date : 2023-03-21
DMF Number : 38005
Submission : 2023-03-31
Status : Active
Type : II
A Trifarotene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trifarotene, including repackagers and relabelers. The FDA regulates Trifarotene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trifarotene 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 Trifarotene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trifarotene supplier is an individual or a company that provides Trifarotene active pharmaceutical ingredient (API) or Trifarotene finished formulations upon request. The Trifarotene suppliers may include Trifarotene API manufacturers, exporters, distributors and traders.
click here to find a list of Trifarotene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trifarotene DMF (Drug Master File) is a document detailing the whole manufacturing process of Trifarotene active pharmaceutical ingredient (API) in detail. Different forms of Trifarotene DMFs exist exist since differing nations have different regulations, such as Trifarotene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trifarotene DMF submitted to regulatory agencies in the US is known as a USDMF. Trifarotene USDMF includes data on Trifarotene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trifarotene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trifarotene suppliers with USDMF on PharmaCompass.
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