EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 2EUROAPI
02 1Calyx Chemicals & Pharmaceuticals Limited
03 1Cambrex Corporation
04 1Centaur Pharmaceuticals
05 1DEAFARMA
06 2F.I.S. Fabbrica Italiana Sintetici
07 1HONOUR LAB LTD
08 1Harman Finochem
09 1Hetero Drugs
10 1Lake Chemicals
11 2MSN Laboratories
12 1Micro Labs Limited
13 1Piramal Pharma Solutions
14 1R L Fine Chem
15 1Raks Pharma
16 1Unipex
01 3France
02 11India
03 3Italy
04 2U.S.A
01 9Active
02 1Inactive
03 9Blank
01 6Valid
02 13Blank
01 1218MF10337
02 18Blank
01 1WC-0101
02 1WC-0107
03 1WC-0123
04 1WC-0225A3
05 1WC-0362
06 1WC-0383A4
07 1WC-0383A8
08 12Blank
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-27
Pay. Date : 2013-02-13
DMF Number : 18340
Submission : 2005-05-09
Status : Active
Type : II
Certificate Number : R1-CEP 2004-314 - Rev 01
Issue Date : 2022-02-08
Type : Chemical
Substance Number : 1974
Status : Valid
Registration Number : 218MF10337
Registrant's Address : Brueningstrasse 50, 65926 Frankfurt am Main, Germany
Initial Date of Registration : 2006-03-09
Latest Date of Registration : --
NDC Package Code : 82348-103
Start Marketing Date : 2020-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ROW |
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : R1-CEP 2016-281 - Rev 00
Issue Date : 2022-02-16
Type : Chemical
Substance Number : 1974
Status : Valid
NDC Package Code : 82348-103
Start Marketing Date : 2020-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ROW |
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-02
Pay. Date : 2015-03-11
DMF Number : 24728
Submission : 2011-02-28
Status : Active
Type : II
NDC Package Code : 48087-0094
Start Marketing Date : 2010-11-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-02
Pay. Date : 2015-09-24
DMF Number : 29164
Submission : 2015-03-28
Status : Active
Type : II
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0123
Address of the Firm :
NDC Package Code : 65085-0054
Start Marketing Date : 2018-12-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-07
Pay. Date : 2017-10-10
DMF Number : 30875
Submission : 2016-09-02
Status : Active
Type : II
Certificate Number : R1-CEP 2016-322 - Rev 00
Issue Date : 2023-07-18
Type : Chemical
Substance Number : 1974
Status : Valid
Date of Issue : 2021-02-12
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A8
Address of the Firm :
NDC Package Code : 69766-016
Start Marketing Date : 2016-08-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-01-04
Pay. Date : 2017-12-02
DMF Number : 32059
Submission : 2017-11-30
Status : Active
Type : II
Certificate Number : CEP 2019-168 - Rev 02
Issue Date : 2024-10-14
Type : Chemical
Substance Number : 1974
Status : Valid
Date of Issue : 2020-01-16
Valid Till : 2022-08-15
Written Confirmation Number : WC-0225A3
Address of the Firm :
NDC Package Code : 42571-308
Start Marketing Date : 2022-01-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-08-24
Pay. Date : 2015-05-26
DMF Number : 29351
Submission : 2015-06-02
Status : Active
Type : II
Certificate Number : R1-CEP 2016-237 - Rev 00
Issue Date : 2023-02-13
Type : Chemical
Substance Number : 1974
Status : Valid
Date of Issue : 2019-07-26
Valid Till : 2022-05-05
Written Confirmation Number : WC-0362
Address of the Firm :
NDC Package Code : 69037-0009
Start Marketing Date : 2011-10-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-13
Pay. Date : 2015-06-05
DMF Number : 29407
Submission : 2015-05-29
Status : Active
Type : II
Certificate Number : CEP 2004-118 - Rev 04
Issue Date : 2023-10-19
Type : Chemical
Substance Number : 1974
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-06-25
Written Confirmation Number : WC-0107
Address of the Firm :
NDC Package Code : 64330-110
Start Marketing Date : 2015-02-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-08
Pay. Date : 2016-05-20
DMF Number : 30540
Submission : 2016-05-30
Status : Active
Type : II
NDC Package Code : 47621-047
Start Marketing Date : 2016-03-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18080
Submission : 2005-02-10
Status : Inactive
Type : II
NDC Package Code : 48087-0094
Start Marketing Date : 2010-11-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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