Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1AXYNTIS Group
03 1Centaur Pharmaceuticals
04 1MIKAH PHARMA LLC
05 2Blank
01 1France
02 1India
03 1Spain
04 1U.S.A
05 2Blank
01 2Active
02 3Inactive
03 1Blank
01 6Blank
01 6Blank
01 1WC-0107
02 5Blank
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-05-25
Pay. Date : 2021-05-20
DMF Number : 6767
Submission : 1986-12-29
Status : Active
Type : II
NDC Package Code : 53296-0017
Start Marketing Date : 2010-03-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-14
Pay. Date : 2019-05-03
DMF Number : 29977
Submission : 2015-11-06
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-25
Written Confirmation Number : WC-0107
Address of the Firm :
NDC Package Code : 64330-112
Start Marketing Date : 2015-02-18
End Marketing Date : 2025-12-31
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 : 3447
Submission : 1979-02-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 8812
Submission : 1990-11-05
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7577
Submission : 1988-07-11
Status : Inactive
Type : II
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