01 1Aurobindo Pharma Limited
02 3Cipla
03 2Hetero Drugs
04 1Innovare Labs
05 1Johnson & Johnson Innovative Medicine
06 1Laurus Labs
07 2Lupin Ltd
08 2MSN Laboratories
09 1Raks Pharma
10 2Viatris
11 2Zhejiang Jiuzhou Pharmaceutical
12 1Zydus Lifesciences
01 8DARUNAVIR
02 2DARUNAVIR (AMORPHOUS)
03 1DARUNAVIR (PROCESS-II)
04 1DARUNAVIR (R319064) DRUG SUBSTANCE
05 1DARUNAVIR AMORPHOUS
06 1DARUNAVIR AMORPHOUS (PROCESS-II)
07 1DARUNAVIR HYDRATE
08 1DARUNAVIR HYDRATE (PROCESS II)
09 1DARUNAVIR N-PROPANOLATE
10 1DARUNAVIR PROPYLENE GLYCOLATE
11 1DARUNAVIR [ROUTE CODE - "DI"]
01 2China
02 14India
03 3U.S.A
01 13Active
02 6Inactive
01 9Complete
02 10Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2017-01-25
DMF Number : 31358
Submission : 2017-01-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-29
Pay. Date : 2013-09-20
DMF Number : 23661
Submission : 2010-07-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-29
Pay. Date : 2013-09-20
DMF Number : 23660
Submission : 2011-03-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23854
Submission : 2010-06-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18825
Submission : 2005-11-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-03
Pay. Date : 2016-12-20
DMF Number : 31198
Submission : 2017-10-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-27
Pay. Date : 2018-03-14
DMF Number : 30882
Submission : 2016-10-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-19
Pay. Date : 2016-09-30
DMF Number : 30803
Submission : 2016-10-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23873
Submission : 2010-06-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-19
Pay. Date : 2016-06-21
DMF Number : 30596
Submission : 2016-06-27
Status : Active
Type : II
A Darunavir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Darunavir, including repackagers and relabelers. The FDA regulates Darunavir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Darunavir 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 Darunavir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Darunavir supplier is an individual or a company that provides Darunavir active pharmaceutical ingredient (API) or Darunavir finished formulations upon request. The Darunavir suppliers may include Darunavir API manufacturers, exporters, distributors and traders.
click here to find a list of Darunavir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Darunavir DMF (Drug Master File) is a document detailing the whole manufacturing process of Darunavir active pharmaceutical ingredient (API) in detail. Different forms of Darunavir DMFs exist exist since differing nations have different regulations, such as Darunavir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Darunavir DMF submitted to regulatory agencies in the US is known as a USDMF. Darunavir USDMF includes data on Darunavir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Darunavir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Darunavir suppliers with USDMF on PharmaCompass.
We have 12 companies offering Darunavir
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