Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Nuray Chemicals Private Limited
03 1HRV Global Life Sciences
04 1Omgene Life Sciences Pvt. Ltd
05 1Alven Laboratories
06 1Danesh Kimia Pharmed
07 1Dipharma SA
08 1Hetero Drugs
09 1Saurav Chemicals
10 1Sionc Pharmaceuticals
11 1Teva API
01 1Czech Republic
02 7India
03 1Iran
04 1Israel
05 1Switzerland
01 5Active
02 6Blank
01 11Blank
01 11Blank
01 1WC-0171Amendment
02 1WC-0273
03 1WC-0416
04 8Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-28
Pay. Date : 2020-08-06
DMF Number : 33948
Submission : 2019-07-17
Status : Active
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-01
Pay. Date : 2016-12-26
DMF Number : 31250
Submission : 2017-01-02
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-037
Start Marketing Date : 2020-02-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35810
Submission : 2021-03-31
Status : Active
Type : II
Date of Issue : 2021-09-17
Valid Till : 2022-08-13
Written Confirmation Number : WC-0171Amendment
Address of the Firm :
NDC Package Code : 43235-0016
Start Marketing Date : 2020-03-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-22
Pay. Date : 2016-10-11
DMF Number : 30680
Submission : 2016-10-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-21
Pay. Date : 2021-08-02
DMF Number : 36026
Submission : 2021-07-31
Status : Active
Type : II
Date of Issue : 2020-07-23
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
NDC Package Code : 76055-0043
Start Marketing Date : 2019-07-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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