Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
02 1Minakem (formerly Delmar Chemicals)
03 1Sanofi
04 1Jai Radhe Sales
05 1Amsal Chem Private Ltd.
06 1Anuh Pharma LTD
07 1Bracco
08 1Calyx Chemicals & Pharmaceuticals Limited
09 1DIFC CO
10 1Ishita Drugs & Industries
11 2Linaria Chemicals
12 1Lupin Ltd
13 1Macleods Pharmaceuticals Limited
14 1Otto Brandes
15 1Suchem Laboratories
16 1Viatris
17 1Blank
01 1Canada
02 2France
03 1Germany
04 8India
05 1Italy
06 1South Korea
07 2Thailand
08 1U.S.A
09 1Blank
01 4Active
02 3Inactive
03 11Blank
01 4Valid
02 2Withdrawn by EDQM Failure to CEP procedure
03 12Blank
01 18Blank
01 1WC-0086
02 1WC-0088
03 1WC-0172
04 1WC-0201
05 14Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15325
Submission : 2001-02-28
Status : Active
Type : II
NDC Package Code : 11712-815
Start Marketing Date : 1999-05-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14623
Submission : 1999-12-16
Status : Inactive
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-30
Pay. Date : 2015-10-15
DMF Number : 15553
Submission : 2001-07-31
Status : Active
Type : II
Certificate Number : R1-CEP 2000-036 - Rev 05
Issue Date : 2018-02-16
Type : Chemical
Substance Number : 859
Status : Valid
Date of Issue : 2019-09-09
Valid Till : 2022-09-08
Written Confirmation Number : WC-0088
Address of the Firm :
NDC Package Code : 66639-165
Start Marketing Date : 2009-09-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2009-09-24
Registration Number : 20090924-110-F-42-03
Manufacturer Name : Calyx Chemicals & Pharmaceuticals Ltd.
Manufacturer Address : N 102, 90, 91 MIDC, TARAPUR,BOISAR THANE 401506 MAHARASHTRA STATE, INDIA
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-10-21
Pay. Date : 2016-08-24
DMF Number : 30448
Submission : 2016-05-25
Status : Active
Type : II
Certificate Number : R1-CEP 2016-138 - Rev 01
Issue Date : 2023-03-27
Type : Chemical
Substance Number : 859
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34229
Submission : 2019-11-01
Status : Active
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 : 8604
Submission : 1990-06-20
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 : 5909
Submission : 1985-06-27
Status : Inactive
Type : II
Certificate Number : R1-CEP 2015-283 - Rev 00
Issue Date : 2023-04-06
Type : Chemical
Substance Number : 859
Status : Valid
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