Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 2Minakem
02 1Minakem (formerly Delmar Chemicals)
03 1Aspen API
04 1Fine Chemicals Corporation PTY Ltd
05 1Zeon Pharma Industries India Pvt Ltd
06 2Cipla
07 2Gedeon Richter
08 1Hubei Honch Pharmaceutical
09 1Medimpex
10 1Plantex Ltd.
11 1Sakar Healthcare
12 1Vinkem Labs Ltd
13 1Zhejiang Hisun Pharmaceutical
14 1Blank
01 1Canada
02 2China
03 2France
04 2Hungary
05 5India
06 1Israel
07 1Netherlands
08 1South Africa
09 1United Kingdom
10 1Blank
01 2Active
02 6Inactive
03 9Blank
01 4Valid
02 1Withdrawn by Holder
03 12Blank
01 1220MF10116
02 1306MF10066
03 15Blank
01 1WC-0113
02 1WC-0138
03 15Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-27
Pay. Date : 2017-11-27
DMF Number : 5335
Submission : 1984-04-13
Status : Active
Type : II
Certificate Number : R0-CEP 2020-065 - Rev 01
Issue Date : 2023-07-17
Type : Chemical
Substance Number : 748
Status : Valid
NDC Package Code : 69910-0002
Start Marketing Date : 2015-06-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registration Number : 306MF10066
Registrant's Address : 15 Hawkins Avenue, Epping 1,7460, Cape Town, South Africa
Initial Date of Registration : 2024-05-15
Latest Date of Registration : --
NDC Package Code : 48954-588
Start Marketing Date : 1982-05-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Certificate Number : R1-CEP 2004-073 - Rev 02
Issue Date : 2015-08-04
Type : Chemical
Substance Number : 748
Status : Valid
NDC Package Code : 69910-0002
Start Marketing Date : 2015-06-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39264
Submission : 2024-03-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16240
Submission : 2002-11-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3499
Submission : 1979-04-05
Status : Inactive
Type : II
Certificate Number : R1-CEP 2005-261 - Rev 00
Issue Date : 2011-11-04
Type : Chemical
Substance Number : 748
Status : Valid
Registration Number : 220MF10116
Registrant's Address : BUDAPEST, GYOMROI UT 19-21, HUNGARY
Initial Date of Registration : 2008-04-28
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4978
Submission : 1983-07-06
Status : Inactive
Type : II
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