EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1Transo-Pharm USA LLC
03 1DKSH
04 1Bayer AG
05 1Curia
06 1Fujifilm Diosynth Biotechnologies
07 1Henan Lihua Pharmaceutical
08 1Hikma Pharmaceuticals
09 1Laboratorio Syntex S.A
10 2Pfizer Inc
11 1Shandong Xinhua Pharmaceutical
12 1Tianjin Tianyao Pharmaceuticals Co., Ltd.
13 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 1Argentina
02 4China
03 1France
04 1Germany
05 1Switzerland
06 4U.S.A
07 2United Kingdom
01 7Active
02 3Inactive
03 4Blank
01 4Valid
02 2Withdrawn by Holder
03 8Blank
01 14Blank
01 14Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-05
Pay. Date : 2013-01-02
DMF Number : 2874
Submission : 1977-02-28
Status : Active
Type : II
Certificate Number : R1-CEP 2001-251 - Rev 04
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 354
Status : Valid
NDC Package Code : 82298-103
Start Marketing Date : 2011-02-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ROW |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35461
Submission : 2020-12-22
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-05
Pay. Date : 2016-03-16
DMF Number : 30194
Submission : 2015-12-24
Status : Active
Type : II
Certificate Number : CEP 2018-027 - Rev 02
Issue Date : 2024-04-02
Type : Chemical
Substance Number : 354
Status : Valid
NDC Package Code : 60722-1002
Start Marketing Date : 2016-01-06
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 : 16000
Submission : 2002-06-10
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-25
Pay. Date : 2014-01-09
DMF Number : 24749
Submission : 2011-03-10
Status : Active
Type : II
Certificate Number : R1-CEP 2005-240 - Rev 04
Issue Date : 2020-02-26
Type : Chemical
Substance Number : 354
Status : Valid
NDC Package Code : 64958-0002
Start Marketing Date : 2003-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-11
Pay. Date : 2012-12-11
DMF Number : 11289
Submission : 1994-10-07
Status : Active
Type : II
Certificate Number : R1-CEP 2003-135 - Rev 04
Issue Date : 2018-01-15
Type : Chemical
Substance Number : 354
Status : Valid
NDC Package Code : 57582-003
Start Marketing Date : 2012-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 241
Submission : 1957-01-29
Status : Inactive
Type : II
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 : 3956
Submission : 1980-07-17
Status : Inactive
Type : II
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