Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
01 1Porton Pharma Solutions
02 1Arene Lifesciences
03 1Chromo Laboratories
04 1Cipla
05 2Hetero Drugs
06 1Laurus Labs
07 2Lupin Ltd
08 2MSN Laboratories
09 1Micro Labs Limited
10 1Viatris
01 10DARUNAVIR ETHANOLATE
02 1DARUNAVIR ETHANOLATE (PROCESS-B)
03 1DARUNAVIR ETHANOLATE (PROCESS-II)
04 1DARUNAVIR ETHANOLATE [ROUTE CODE - DN]
01 1China
02 11India
03 1U.S.A
01 11Active
02 2Inactive
01 6Complete
02 7Blank
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33798
Submission : 2019-04-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37916
Submission : 2023-03-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36976
Submission : 2024-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-20
Pay. Date : 2014-02-14
DMF Number : 23662
Submission : 2010-06-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-15
Pay. Date : 2017-01-20
DMF Number : 27997
Submission : 2014-02-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31011
Submission : 2016-10-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-28
Pay. Date : 2017-10-10
DMF Number : 31498
Submission : 2017-04-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-21
Pay. Date : 2015-09-18
DMF Number : 29157
Submission : 2015-09-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-12
Pay. Date : 2019-07-08
DMF Number : 30589
Submission : 2016-06-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-06
Pay. Date : 2016-07-26
DMF Number : 30735
Submission : 2016-07-29
Status : Active
Type : II
A Prezista manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prezista, including repackagers and relabelers. The FDA regulates Prezista manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prezista 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 Prezista manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prezista supplier is an individual or a company that provides Prezista active pharmaceutical ingredient (API) or Prezista finished formulations upon request. The Prezista suppliers may include Prezista API manufacturers, exporters, distributors and traders.
click here to find a list of Prezista suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prezista DMF (Drug Master File) is a document detailing the whole manufacturing process of Prezista active pharmaceutical ingredient (API) in detail. Different forms of Prezista DMFs exist exist since differing nations have different regulations, such as Prezista USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prezista DMF submitted to regulatory agencies in the US is known as a USDMF. Prezista USDMF includes data on Prezista's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prezista USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prezista suppliers with USDMF on PharmaCompass.
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