Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 2Biophore India Pharmaceuticals Pvt Ltd
02 1Transo-Pharm USA LLC
03 1Ahk Tech
04 1Aspen Biopharma Labs
05 1Axitec
06 2Cilag AG
07 1Guangzhou Henovcom Biosciences
08 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
09 1Lipomed AG
10 2MSN Laboratories
11 1Mac-Chem Products (India) Pvt.Ltd
12 1Morepen Laboratories
13 1Reliable Biopharmaceutical Corporation
14 1ScinoPharm Taiwan, Ltd
15 1Sichuan Huiyu Pharmaceutical
16 1Zhejiang Hisun Pharmaceutical
01 6China
02 7India
03 3Switzerland
04 1Taiwan
05 2U.S.A
01 10Active
02 3Inactive
03 6Blank
01 6Valid
02 1Withdrawn by Holder
03 12Blank
01 1305MF10067
02 18Blank
01 1WC-0349
02 18Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-09
Pay. Date : 2021-09-28
DMF Number : 36221
Submission : 2021-08-30
Status : Active
Type : II
Certificate Number : CEP 2022-078 - Rev 00
Issue Date : 2024-06-03
Type : Chemical
Substance Number : 2174
Status : Valid
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36222
Submission : 2021-08-31
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-18
DMF Number : 16205
Submission : 2002-10-22
Status : Active
Type : II
Certificate Number : R0-CEP 2012-132 - Rev 00
Issue Date : 2014-10-29
Type : Chemical
Substance Number : 2174
Status : Withdrawn by Holder
NDC Package Code : 58623-0037
Start Marketing Date : 2004-04-22
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 : 35806
Submission : 2021-03-31
Status : Active
Type : II
Certificate Number : R0-CEP 2021-217 - Rev 01
Issue Date : 2023-08-11
Type : Chemical
Substance Number : 2174
Status : Valid
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0115
Start Marketing Date : 2021-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-03-08
Pay. Date : 2015-08-13
DMF Number : 24510
Submission : 2010-12-30
Status : Active
Type : II
Certificate Number : CEP 2016-315 - Rev 01
Issue Date : 2024-09-11
Type : Chemical
Substance Number : 2174
Status : Valid
NDC Package Code : 65129-1260
Start Marketing Date : 2010-05-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31505
Submission : 2017-05-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-15
Pay. Date : 2018-06-27
DMF Number : 13006
Submission : 1998-05-28
Status : Active
Type : II
NDC Package Code : 59605-3006
Start Marketing Date : 1998-05-28
End Marketing Date : 2027-05-11
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18072
Submission : 2005-01-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23228
Submission : 2009-10-16
Status : Inactive
Type : II
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