Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
01 1Porton Pharma Solutions
02 1Amara Labs
03 1Arene Lifesciences
04 1Chromo Laboratories
05 2Cipla
06 2Hetero Drugs
07 1Laurus Labs
08 2Lupin Ltd
09 2MSN Laboratories
10 1Micro Labs Limited
11 1Viatris
01 1China
02 13India
03 1U.S.A
01 11Active
02 2Inactive
03 2Blank
01 15Blank
01 15Blank
01 1WC-0022
02 1WC-0141
03 1WC-0144nA2
04 1WC-0213
05 1WC-0225A7
06 1WC-0383A4
07 9Blank
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33798
Submission : 2019-04-22
Status : Active
Type : II
NDC Package Code : 75877-0007
Start Marketing Date : 2019-03-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38980
Submission : 2024-05-15
Status : Active
Type : II
Date of Issue : 2023-07-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0213
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-01-21
Pay. Date : 2015-09-18
DMF Number : 29157
Submission : 2015-09-17
Status : Active
Type : II
Date of Issue : 2020-06-23
Valid Till : 2022-08-15
Written Confirmation Number : WC-0225A7
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-10-06
Pay. Date : 2016-07-26
DMF Number : 30735
Submission : 2016-07-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-28
Pay. Date : 2017-10-10
DMF Number : 31498
Submission : 2017-04-15
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 : Reviewed
Rev. Date : 2017-02-15
Pay. Date : 2017-01-20
DMF Number : 27997
Submission : 2014-02-14
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-12
Pay. Date : 2019-07-08
DMF Number : 30589
Submission : 2016-06-06
Status : Active
Type : II
Date of Issue : 2019-10-15
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A4
Address of the Firm :
NDC Package Code : 50370-0042
Start Marketing Date : 2013-08-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23850
Submission : 2011-02-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27421
Submission : 2013-08-26
Status : Inactive
Type : II
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm :
NDC Package Code : 50370-0042
Start Marketing Date : 2013-08-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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.
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