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01 1EUROAPI
02 1Sanofi
03 1Arudavis Labs
04 1CKD Bio Corporation
05 1Fermic
06 1Gujarat Themis Biosyn
07 1Lupin Ltd
08 1Novartis Pharmaceuticals Corporation
09 2Olon S.p.A
10 1Otto Brandes
11 1Qingdao Qingmei Biotech
12 1Sichuan Long March Pharmaceutical Co. Ltd.
13 1Zhengzhou Minzhong Pharmaceutical
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01 3China
02 2France
03 1Germany
04 3India
05 2Italy
06 1Mexico
07 1South Korea
08 1Switzerland
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01 6Active
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01 1Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
04 12Blank
01 1218MF10388
02 14Blank
01 1WC-0197
02 1WC-0201
03 13Blank
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-12
Pay. Date : 2013-01-22
DMF Number : 13383
Submission : 1998-09-01
Status : Active
Type : II
Registration Number : 218MF10388
Registrant's Address : Via Angelo Titi, 22/26, Zona ex punto franco, 72100 Brindisi, Italy
Initial Date of Registration : 2006-03-20
Latest Date of Registration : --
NDC Package Code : 82297-101
Start Marketing Date : 1973-04-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF, ROW |
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R0-CEP 2000-337 - Rev 03
Issue Date : 2005-02-18
Type : TSE
Substance Number : 52
Status : Withdrawn by Holder
NDC Package Code : 66075-7960
Start Marketing Date : 1973-04-09
End Marketing Date : 2025-03-07
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-04
Pay. Date : 2013-09-26
DMF Number : 13663
Submission : 1998-09-01
Status : Active
Type : II
NDC Package Code : 52972-0026
Start Marketing Date : 1998-11-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2009-01-30
Registration Number : 20090130-103-F-36-01
Manufacturer Name : Chong Kun Dang Bio Co., Ltd._x000D_
Manufacturer Address : 454,486 Biblock 16 Complex, Moknae-dong, Danwon-gu, Ansan-si, Gyeonggi-do (425-100) (368-3, Chungjeong-ro 3-ga, Seodaemun-gu, Seoul (120-756))
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38768
Submission : 2023-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13796
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2009-275 - Rev 05
Issue Date : 2024-05-27
Type : Chemical
Substance Number : 52
Status : Valid
Date of Issue : 2019-09-09
Valid Till : 2022-09-08
Written Confirmation Number : WC-0197
Address of the Firm :
NDC Package Code : 17337-0031
Start Marketing Date : 2012-12-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-05-13
Pay. Date : 2022-03-29
DMF Number : 36879
Submission : 2022-04-04
Status : Active
Type : II
NDC Package Code : 17337-0031
Start Marketing Date : 2012-12-27
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 : 13644
Submission : 1998-09-01
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 : 13398
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13717
Submission : 1998-09-01
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 : 10027
Submission : 1992-12-30
Status : Inactive
Type : II
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