01 1Cipla
02 2Johnson & Johnson Innovative Medicine
03 1MSN Laboratories
01 2RILPIVIRINE
02 1RILPIVIRINE DRUG SUBSTANCE
03 1RILPIVIRINE EXTENDED RELEASE SUSPENSION FOR INJECTION
01 2India
02 2U.S.A
01 4Active
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37940
Submission : 2023-03-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33715
Submission : 2019-04-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33713
Submission : 2019-04-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39729
Submission : 2024-03-28
Status : Active
Type : II
A Rilpivirine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rilpivirine, including repackagers and relabelers. The FDA regulates Rilpivirine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rilpivirine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rilpivirine supplier is an individual or a company that provides Rilpivirine active pharmaceutical ingredient (API) or Rilpivirine finished formulations upon request. The Rilpivirine suppliers may include Rilpivirine API manufacturers, exporters, distributors and traders.
click here to find a list of Rilpivirine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rilpivirine DMF (Drug Master File) is a document detailing the whole manufacturing process of Rilpivirine active pharmaceutical ingredient (API) in detail. Different forms of Rilpivirine DMFs exist exist since differing nations have different regulations, such as Rilpivirine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rilpivirine DMF submitted to regulatory agencies in the US is known as a USDMF. Rilpivirine USDMF includes data on Rilpivirine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rilpivirine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rilpivirine suppliers with USDMF on PharmaCompass.
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