Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
01 1Gentec Pharmaceutical Group
02 1Chirogate International
03 1Cayman Pharma s.r.o
04 1Century Pharmaceuticals
05 1Everlight Chemical
06 1Fleming Laboratories
07 1Kimia Biosciences
08 2MSN Laboratories
09 1Mankind Pharma
10 1Yonsung Fine Chemicals
11 1Zhejiang Ausun Pharmaceutical
12 1Blank
01 1China
02 1Czech Republic
03 6India
04 1South Korea
05 1Spain
06 2Taiwan
07 1Blank
01 5Active
02 8Blank
01 13Blank
01 13Blank
01 1WC-0349
02 1WC-0349A9
03 11Blank
Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37976
Submission : 2023-04-24
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-01-24
Pay. Date : 2023-04-27
DMF Number : 37429
Submission : 2023-05-30
Status : Active
Type : II
Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-16
Pay. Date : 2020-09-30
DMF Number : 34033
Submission : 2019-08-01
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0091
Start Marketing Date : 2019-08-01
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 : 39153
Submission : 2023-12-27
Status : Active
Type : II
Date of Issue : 2020-09-30
Valid Till : 2022-05-05
Written Confirmation Number : WC-0349A9
Address of the Firm :
NDC Package Code : 54893-0091
Start Marketing Date : 2019-08-01
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 : 40478
Submission : 2024-09-27
Status : Active
Type : II
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