Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Dr. Reddy's Laboratories
03 1Alembic Pharmaceuticals Limited
04 1Anax Laboratories
05 1Apicore LLC
06 1Fresenius Kabi Oncology Limited
07 1GLAND PHARMA LIMITED
08 1Hetero Drugs
09 1Hunan Huateng Pharmaceutical Co ltd
10 1MSN Laboratories
11 1Sionc Pharmaceuticals
12 1Viatris
01 1China
02 10India
03 1U.S.A
01 6Active
02 1Inactive
03 5Blank
01 12Blank
01 12Blank
01 1WC-0041
02 1WC-0067
03 1WC-0082
04 1WC-0110
05 1WC-0115A3
06 1WC-0273
07 1WC-0349
08 1WC-0427A3-4
09 4Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-11-06
Pay. Date : 2015-08-25
DMF Number : 29507
Submission : 2015-07-04
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-954
Start Marketing Date : 2012-11-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-13
Pay. Date : 2017-04-21
DMF Number : 31572
Submission : 2017-04-26
Status : Active
Type : II
Date of Issue : 2022-08-04
Valid Till : 2025-03-04
Written Confirmation Number : WC-0427A3-4
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-13
Pay. Date : 2018-09-25
DMF Number : 32341
Submission : 2018-01-07
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-03
Pay. Date : 2017-10-06
DMF Number : 30877
Submission : 2016-09-06
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0050
Start Marketing Date : 2016-08-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-06
Pay. Date : 2012-11-30
DMF Number : 26603
Submission : 2012-11-12
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 : 68554-0067
Start Marketing Date : 2008-12-15
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 : 36278
Submission : 2021-09-30
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 32615
Submission : 2018-05-18
Status : Inactive
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-15
Written Confirmation Number : WC-0115A3
Address of the Firm :
Date of Issue : 2020-07-23
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
NDC Package Code : 76055-0017
Start Marketing Date : 2019-12-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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