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 Rilpivirine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rilpivirine Hydrochloride, including repackagers and relabelers. The FDA regulates Rilpivirine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rilpivirine Hydrochloride 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 Rilpivirine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rilpivirine Hydrochloride supplier is an individual or a company that provides Rilpivirine Hydrochloride active pharmaceutical ingredient (API) or Rilpivirine Hydrochloride finished formulations upon request. The Rilpivirine Hydrochloride suppliers may include Rilpivirine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Rilpivirine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rilpivirine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Rilpivirine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Rilpivirine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Rilpivirine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rilpivirine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Rilpivirine Hydrochloride USDMF includes data on Rilpivirine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rilpivirine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rilpivirine Hydrochloride suppliers with USDMF on PharmaCompass.
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