HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
01 1HRV Global Life Sciences
02 1Granules India Limited
03 1Aspen Biopharma Labs
04 1Aurobindo Pharma Limited
05 1Aurore Life Sciences
06 3Cipla
07 1Globe Quimica Ltda
08 1Guangzhou Tosun Pharmaceutical
09 1Hangzhou Longshine Bio-Tech
10 2Hetero Drugs
11 1Innovare Labs
12 1Johnson & Johnson Innovative Medicine
13 1Laurus Labs
14 2Lupin Ltd
15 2MSN Laboratories
16 1Nanjing Clasien Pharmaceutical & Chemical Co., Ltd
17 1Raks Pharma
18 2Viatris
19 2Zhejiang Jiuzhou Pharmaceutical
20 1Zydus Lifesciences
01 1Brazil
02 5China
03 18India
04 3U.S.A
01 13Active
02 6Inactive
03 8Blank
01 27Blank
01 27Blank
01 1WC-0022
02 1WC-0023
03 1WC-0024
04 1WC-0041
05 1WC-0118
06 1WC-0141
07 1WC-0213
08 1WC-0383A4
09 19Blank
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-03
Pay. Date : 2016-12-20
DMF Number : 31198
Submission : 2017-10-24
Status : Active
Type : II
Date of Issue : 2023-07-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0213
Address of the Firm :
NDC Package Code : 42385-728
Start Marketing Date : 2017-02-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23873
Submission : 2010-06-10
Status : Active
Type : II
Date of Issue : 2019-08-05
Valid Till : 2022-08-04
Written Confirmation Number : WC-0118
Address of the Firm :
NDC Package Code : 65015-761
Start Marketing Date : 2015-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-19
Pay. Date : 2016-06-21
DMF Number : 30596
Submission : 2016-06-27
Status : Active
Type : II
NDC Package Code : 65015-761
Start Marketing Date : 2015-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35508
Submission : 2021-02-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-19
Pay. Date : 2016-09-30
DMF Number : 30803
Submission : 2016-10-05
Status : Active
Type : II
NDC Package Code : 47621-302
Start Marketing Date : 2017-06-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23854
Submission : 2010-06-02
Status : Active
Type : II
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0035
Start Marketing Date : 2006-06-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-10
Pay. Date : 2021-04-16
DMF Number : 35834
Submission : 2021-04-10
Status : Active
Type : II
NDC Package Code : 68554-0035
Start Marketing Date : 2006-06-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-19
Pay. Date : 2019-05-28
DMF Number : 33895
Submission : 2019-05-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-23
Pay. Date : 2017-01-25
DMF Number : 31358
Submission : 2017-01-25
Status : Active
Type : II
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0023
Address of the Firm :
NDC Package Code : 59651-102
Start Marketing Date : 2024-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-27
Pay. Date : 2018-03-14
DMF Number : 30882
Submission : 2016-10-05
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 : 50370-0037
Start Marketing Date : 2013-04-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-29
Pay. Date : 2013-09-20
DMF Number : 23660
Submission : 2011-03-16
Status : Active
Type : II
Date of Issue : 2019-06-26
Valid Till : 2019-07-07
Written Confirmation Number : WC-0141
Address of the Firm :
NDC Package Code : 53104-7694
Start Marketing Date : 2010-12-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-29
Pay. Date : 2013-09-20
DMF Number : 23661
Submission : 2010-07-06
Status : Active
Type : II
NDC Package Code : 53104-7694
Start Marketing Date : 2010-12-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18825
Submission : 2005-11-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27436
Submission : 2013-08-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31494
Submission : 2017-02-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29118
Submission : 2015-04-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29455
Submission : 2015-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27038
Submission : 2013-04-20
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 : 50370-0037
Start Marketing Date : 2013-04-20
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 : 30286
Submission : 2016-04-04
Status : Inactive
Type : II
NDC Package Code : 53104-7694
Start Marketing Date : 2010-12-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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.
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