01 1Apotex Pharmachem
02 1CHEMO
03 1DEAFARMA
04 1MSN Laboratories
05 1Zhejiang Ausun Pharmaceutical
01 1Canada
02 1China
03 1India
04 1Italy
05 1Spain
01 3Active
02 2Blank
01 5Blank
01 5Blank
01 5Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2018-01-18
Pay. Date : 2017-09-20
DMF Number : 32077
Submission : 2017-11-07
Status : Active
Type : II
NDC Package Code : 76397-015
Start Marketing Date : 2018-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-30
Pay. Date : 2017-07-26
DMF Number : 31843
Submission : 2017-07-31
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-05
Pay. Date : 2017-09-22
DMF Number : 31948
Submission : 2017-08-30
Status : Active
Type : II
NDC Package Code : 69766-039
Start Marketing Date : 2017-08-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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.
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