EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Fermion Oy
04 1HRV Global Life Sciences
05 2Apicore LLC
06 1Apotex Pharmachem
07 1Arene Lifesciences
08 2Azico Biophore India Pvt. Ltd
09 1Signa S.A. de C.V.
10 1Viatris
11 2Blank
01 1Canada
02 1Finland
03 1France
04 7India
05 1Mexico
06 1U.S.A
07 2Blank
01 4Active
02 1Inactive
03 9Blank
01 3Valid
02 11Blank
01 1219MF10302
02 13Blank
01 1WC-0110
02 1WC-0110a
03 1WC-0118
04 1WC-0404
05 1WC-0404A2
06 9Blank
Certificate Number : R1-CEP 2010-058 - Rev 02
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 1789
Status : Valid
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-08-01
Pay. Date : 2017-06-01
DMF Number : 31735
Submission : 2017-06-01
Status : Active
Type : II
Certificate Number : CEP 2017-209 - Rev 02
Issue Date : 2024-07-16
Type : Chemical
Substance Number : 1789
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-28
Pay. Date : 2014-04-17
DMF Number : 6247
Submission : 1986-04-04
Status : Active
Type : II
Registration Number : 219MF10302
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2007-09-18
Latest Date of Registration : --
NDC Package Code : 12780-0154
Start Marketing Date : 1986-04-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-24
Pay. Date : 2014-08-07
DMF Number : 7426
Submission : 1988-04-11
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-26
Pay. Date : 2015-03-13
DMF Number : 24968
Submission : 2011-10-04
Status : Active
Type : II
Date of Issue : 2019-08-05
Valid Till : 2022-08-04
Written Confirmation Number : WC-0118
Address of the Firm :
NDC Package Code : 65015-718
Start Marketing Date : 2015-01-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11192
Submission : 1994-11-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Date of Issue : 2020-08-17
Valid Till : 2023-06-22
Written Confirmation Number : WC-0404A2
Address of the Firm :
NDC Package Code : 69575-4016
Start Marketing Date : 2021-12-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2009-372 - Rev 04
Issue Date : 2024-07-22
Type : Chemical
Substance Number : 1789
Status : Valid
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110
Address of the Firm :
NDC Package Code : 42973-148
Start Marketing Date : 2008-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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