01 1Apotex Pharmachem
02 2Hetero Drugs
03 1Johnson & Johnson Innovative Medicine
04 1MSN Laboratories
05 1Viatris
01 3ETRAVIRINE
02 1ETRAVIRINE (R165335) DRUG SUBSTANCE
03 1ETRAVIRINE PREMIX
04 1ETRAVIRINE [ROUTE CODE "EV"]
01 1Canada
02 3India
03 2U.S.A
01 5Active
02 1Inactive
01 4Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27923
Submission : 2014-03-07
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-20
Pay. Date : 2021-06-17
DMF Number : 35835
Submission : 2021-06-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-22
Pay. Date : 2014-05-15
DMF Number : 25550
Submission : 2011-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20440
Submission : 2007-04-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-13
Pay. Date : 2019-01-28
DMF Number : 29404
Submission : 2015-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-07
Pay. Date : 2014-11-25
DMF Number : 28813
Submission : 2014-12-22
Status : Active
Type : II
A Etravirine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etravirine, including repackagers and relabelers. The FDA regulates Etravirine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etravirine 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 Etravirine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Etravirine supplier is an individual or a company that provides Etravirine active pharmaceutical ingredient (API) or Etravirine finished formulations upon request. The Etravirine suppliers may include Etravirine API manufacturers, exporters, distributors and traders.
click here to find a list of Etravirine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Etravirine DMF (Drug Master File) is a document detailing the whole manufacturing process of Etravirine active pharmaceutical ingredient (API) in detail. Different forms of Etravirine DMFs exist exist since differing nations have different regulations, such as Etravirine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Etravirine DMF submitted to regulatory agencies in the US is known as a USDMF. Etravirine USDMF includes data on Etravirine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Etravirine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Etravirine suppliers with USDMF on PharmaCompass.
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