01 2Alembic Pharmaceuticals Limited
02 1Gilead Sciences
03 1HONOUR LAB LTD
04 1Hetero Drugs
05 2MSN Laboratories
06 1Mangalam Drugs & Organics Ltd
07 1Prague Scientific
08 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
09 1Sun-shine Chem
10 2Viatris
11 1Zhejiang Ausun Pharmaceutical
01 3China
02 1Czech Republic
03 7India
04 3U.S.A
01 7Active
02 7Blank
01 14Blank
01 14Blank
01 1WC-0082
02 1WC-0082A11
03 1WC-0362
04 1WC-0383A4
05 10Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34649
Submission : 2020-03-30
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-08
Pay. Date : 2016-09-29
DMF Number : 30772
Submission : 2016-08-30
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 : 69766-015
Start Marketing Date : 2016-07-28
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 : 31090
Submission : 2016-12-27
Status : Active
Type : II
NDC Package Code : 69766-015
Start Marketing Date : 2016-07-28
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 : 32456
Submission : 2017-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25187
Submission : 2011-10-21
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-31
Pay. Date : 2013-12-09
DMF Number : 27727
Submission : 2013-12-27
Status : Active
Type : II
NDC Package Code : 65015-839
Start Marketing Date : 2015-03-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-22
Pay. Date : 2015-07-28
DMF Number : 29558
Submission : 2015-08-28
Status : Active
Type : II
NDC Package Code : 65015-839
Start Marketing Date : 2015-03-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-07-26
Valid Till : 2022-05-05
Written Confirmation Number : WC-0362
Address of the Firm :
NDC Package Code : 69037-0002
Start Marketing Date : 2012-08-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2021-10-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0082A11
Address of the Firm :
A Elvitegravir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elvitegravir, including repackagers and relabelers. The FDA regulates Elvitegravir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elvitegravir 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 Elvitegravir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elvitegravir supplier is an individual or a company that provides Elvitegravir active pharmaceutical ingredient (API) or Elvitegravir finished formulations upon request. The Elvitegravir suppliers may include Elvitegravir API manufacturers, exporters, distributors and traders.
click here to find a list of Elvitegravir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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