01 1Cipla
02 1Hetero Drugs
03 1Johnson & Johnson Innovative Medicine
04 1Laurus Labs
05 1MSN Laboratories
06 1Reyoung pharmaceutical
07 1Shanghai Desano Bio-Pharmaceutical
08 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
09 1Viatris
01 7RILPIVIRINE HYDROCHLORIDE
02 1RILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE
03 1RILPIVIRINE HYDROCHLORIDE [ROUTE CODE RC]
01 3China
02 4India
03 2U.S.A
01 8Active
02 1Inactive
01 6Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-04
Pay. Date : 2019-07-29
DMF Number : 30773
Submission : 2017-01-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-11
Pay. Date : 2015-09-24
DMF Number : 29301
Submission : 2015-04-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2012-12-26
DMF Number : 23824
Submission : 2010-07-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-15
Pay. Date : 2015-11-02
DMF Number : 29841
Submission : 2015-12-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-04
Pay. Date : 2018-03-07
DMF Number : 30423
Submission : 2016-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37479
Submission : 2022-09-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26305
Submission : 2012-08-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39552
Submission : 2024-02-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-30
Pay. Date : 2013-07-08
DMF Number : 27253
Submission : 2013-07-24
Status : Active
Type : II
A Edurant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edurant, including repackagers and relabelers. The FDA regulates Edurant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edurant 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 Edurant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Edurant supplier is an individual or a company that provides Edurant active pharmaceutical ingredient (API) or Edurant finished formulations upon request. The Edurant suppliers may include Edurant API manufacturers, exporters, distributors and traders.
click here to find a list of Edurant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Edurant DMF (Drug Master File) is a document detailing the whole manufacturing process of Edurant active pharmaceutical ingredient (API) in detail. Different forms of Edurant DMFs exist exist since differing nations have different regulations, such as Edurant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Edurant DMF submitted to regulatory agencies in the US is known as a USDMF. Edurant USDMF includes data on Edurant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Edurant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Edurant suppliers with USDMF on PharmaCompass.
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