Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Cohance Lifesciences
03 1Laboratorium Ofichem B.V
04 1Medichem S.A
05 1ACG Worldwide
06 3Alembic Pharmaceuticals Limited
07 1Alkaloida Chemical Company Zrt
08 1Changzhou Yabang Pharmaceutical
09 1Changzhou Yabang Pharmaceutical Co ltd
10 1Hetero Drugs
11 1IWAKI SEIYAKU
12 1Kalintis Healthcare
13 2Macleods Pharmaceuticals Limited
14 1Tooba Pharmaceuticals
01 2China
02 1Hungary
03 11India
04 1Japan
05 1Netherlands
06 1Spain
01 7Active
02 2Inactive
03 8Blank
01 4Valid
02 13Blank
01 1217MF10039
02 1220MF10055
03 1230MF10140
04 14Blank
01 1WC-0081
02 1WC-0082
03 1WC-0082A3
04 1WC-0150
05 1WC-0511
06 12Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-09-01
Pay. Date : 2020-08-06
DMF Number : 34668
Submission : 2020-03-06
Status : Active
Type : II
Certificate Number : R0-CEP 2020-384 - Rev 00
Issue Date : 2022-05-17
Type : Chemical
Substance Number : 1029
Status : Valid
Date of Issue : 2021-10-22
Valid Till : 2024-10-21
Written Confirmation Number : WC-0511
Address of the Firm :
NDC Package Code : 73435-007
Start Marketing Date : 2020-02-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-05-12
Pay. Date : 2021-03-24
DMF Number : 34958
Submission : 2020-06-19
Status : Active
Type : II
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0150
Address of the Firm :
NDC Package Code : 17511-136
Start Marketing Date : 2021-06-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-21
Pay. Date : 2019-05-23
DMF Number : 9257
Submission : 1991-07-26
Status : Active
Type : II
NDC Package Code : 53296-0029
Start Marketing Date : 2010-03-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-05
Pay. Date : 2013-02-21
DMF Number : 24714
Submission : 2011-03-09
Status : Active
Type : II
Certificate Number : R1-CEP 2014-057 - Rev 01
Issue Date : 2021-01-11
Type : Chemical
Substance Number : 1029
Status : Valid
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082A3
Address of the Firm :
NDC Package Code : 46708-871
Start Marketing Date : 2011-03-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-09
Pay. Date : 2022-02-24
DMF Number : 36097
Submission : 2021-10-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-01
Pay. Date : 2020-09-21
DMF Number : 35146
Submission : 2020-09-23
Status : Active
Type : II
NDC Package Code : 72166-007
Start Marketing Date : 2019-04-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-19
Pay. Date : 2021-06-02
DMF Number : 35983
Submission : 2021-06-04
Status : Active
Type : II
Certificate Number : R0-CEP 2021-421 - Rev 00
Issue Date : 2023-03-10
Type : Chemical
Substance Number : 1029
Status : Valid
NDC Package Code : 65977-0122
Start Marketing Date : 1985-12-30
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 : 14442
Submission : 1999-10-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10376
Submission : 1993-07-26
Status : Inactive
Type : II
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