01 1Apotex Pharmachem
02 1MSN Laboratories
03 1Zhejiang Ausun Pharmaceutical
01 3TASIMELTEON
01 1Canada
02 1China
03 1India
01 3Active
01 3Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-30
Pay. Date : 2017-07-26
DMF Number : 31843
Submission : 2017-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-05
Pay. Date : 2017-09-22
DMF Number : 31948
Submission : 2017-08-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-18
Pay. Date : 2017-09-20
DMF Number : 32077
Submission : 2017-11-07
Status : Active
Type : II
A Tasimelteon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tasimelteon, including repackagers and relabelers. The FDA regulates Tasimelteon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tasimelteon 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 Tasimelteon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tasimelteon supplier is an individual or a company that provides Tasimelteon active pharmaceutical ingredient (API) or Tasimelteon finished formulations upon request. The Tasimelteon suppliers may include Tasimelteon API manufacturers, exporters, distributors and traders.
click here to find a list of Tasimelteon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tasimelteon DMF (Drug Master File) is a document detailing the whole manufacturing process of Tasimelteon active pharmaceutical ingredient (API) in detail. Different forms of Tasimelteon DMFs exist exist since differing nations have different regulations, such as Tasimelteon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tasimelteon DMF submitted to regulatory agencies in the US is known as a USDMF. Tasimelteon USDMF includes data on Tasimelteon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tasimelteon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tasimelteon suppliers with USDMF on PharmaCompass.
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