Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 2Biophore India Pharmaceuticals Pvt Ltd
02 1Metrochem API Private Limited
03 1Dr. Reddy's Laboratories
04 1Anax Laboratories
05 1Apotex Pharmachem
06 2Azico Biophore India Pvt. Ltd
07 1Cipla
08 1Hetero Drugs
09 2Maithri Drugs
10 1Raks Pharma
11 1SKVen Technologies Pvt. Ltd
12 1Zhejiang Ausun Pharmaceutical
01 1Canada
02 1China
03 13India
01 8Active
02 7Blank
01 15Blank
01 15Blank
01 1WC-0142n
02 1WC-0404
03 1WC-0404A2
04 1WC-0455
05 11Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-04-27
Pay. Date : 2018-03-27
DMF Number : 32572
Submission : 2018-03-20
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-01
Pay. Date : 2018-02-16
DMF Number : 31475
Submission : 2017-03-13
Status : Active
Type : II
NDC Package Code : 71796-009
Start Marketing Date : 2017-03-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-07-09
Pay. Date : 2018-05-30
DMF Number : 32860
Submission : 2018-05-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-05-31
Pay. Date : 2018-04-20
DMF Number : 32724
Submission : 2018-05-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-02-02
Pay. Date : 2017-12-13
DMF Number : 32303
Submission : 2017-12-14
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-05-17
Pay. Date : 2018-03-19
DMF Number : 32537
Submission : 2018-03-30
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-08-04
Written Confirmation Number : WC-0142n
Address of the Firm :
NDC Package Code : 53104-7735
Start Marketing Date : 2018-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-06-29
Pay. Date : 2018-04-06
DMF Number : 32612
Submission : 2018-03-28
Status : Active
Type : II
Date of Issue : 2022-11-18
Valid Till : 2025-09-30
Written Confirmation Number : WC-0455
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32653
Submission : 2018-03-27
Status : Active
Type : II
Date of Issue : 2020-08-17
Valid Till : 2023-06-22
Written Confirmation Number : WC-0404A2
Address of the Firm :
NDC Package Code : 69575-4031
Start Marketing Date : 2021-12-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
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