Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1HRV Global Life Sciences
03 1Alembic Pharmaceuticals Limited
04 1Aurobindo Pharma Limited
05 2Azico Biophore India Pvt. Ltd
06 1Hangzhou Longshine Bio-Tech
07 1Haoyuan Chemexpress Co.Ltd
08 1Hetero Drugs
09 1Intas Pharmaceuticals
10 2MSN Laboratories
11 1Natco Pharma
12 1Taiho Pharmaceutical
01 2China
02 11India
03 1Japan
01 8Active
02 6Blank
01 14Blank
01 14Blank
01 1WC-0349
02 1WC-0349A8
03 1WC-0372
04 1WC-0404
05 1WC-0404A2
06 9Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33217
Submission : 2018-09-28
Status : Active
Type : II
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-25
Pay. Date : 2019-07-25
DMF Number : 33926
Submission : 2019-08-08
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-06-12
Written Confirmation Number : WC-0372
Address of the Firm :
NDC Package Code : 70225-1109
Start Marketing Date : 2018-12-19
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 : 28368
Submission : 2014-11-25
Status : Active
Type : II
Registrant Name : Synex Co., Ltd.
Registration Date : 2018-12-26
Registration Number : Su487-2-ND
Manufacturer Name : Taiho Pharmaceutical Co., Ltd. Saitama Plant
Manufacturer Address : 200-22 Motohara, Kamikawa-machi, Kodama-gun, Saitama 367-0241, Japan
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-12
Pay. Date : 2019-02-14
DMF Number : 33578
Submission : 2019-02-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36239
Submission : 2023-11-20
Status : Active
Type : II
NDC Package Code : 68554-0119
Start Marketing Date : 2015-09-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-28
Pay. Date : 2019-04-22
DMF Number : 33787
Submission : 2019-04-18
Status : Active
Type : II
NDC Package Code : 59651-365
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2020-08-17
Valid Till : 2023-06-22
Written Confirmation Number : WC-0404
Address of the Firm :
NDC Package Code : 69575-4030
Start Marketing Date : 2021-12-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2020-08-17
Valid Till : 2023-06-22
Written Confirmation Number : WC-0404A2
Address of the Firm :
NDC Package Code : 69575-4030
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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