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 1Aspen API
04 1Fine Chemicals Corporation PTY Ltd
05 1Zeon Pharma Industries India Pvt Ltd
06 1Cipla
07 1DMFs Not Supported
08 1Eli Lilly
09 1Gedeon Richter
10 1Hana Pharm
11 1Hubei Honch Pharmaceutical
12 1Medimpex
13 1Parth Antibiotics
14 1Plantex Ltd.
15 1Sakar Healthcare
16 1Surajlok Chemicals
17 1Vinkem Labs Ltd
18 3Blank
01 1Canada
02 1China
03 1France
04 1Hungary
05 6India
06 1Israel
07 1Netherlands
08 1South Africa
09 1South Korea
10 1U.S.A
11 1United Kingdom
12 4Blank
01 3Active
02 9Inactive
03 8Blank
01 4Valid
02 1Withdrawn by Holder
03 15Blank
01 1220MF10117
02 1306MF10067
03 18Blank
01 1WC-0138
02 1WC-0435
03 18Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-25
Pay. Date : 2021-10-21
DMF Number : 4932
Submission : 1983-06-01
Status : Active
Type : II
Certificate Number : R1-CEP 2004-048 - Rev 05
Issue Date : 2023-03-14
Type : Chemical
Substance Number : 749
Status : Valid
NDC Package Code : 69910-0003
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 : 4561
Submission : 1982-05-12
Status : Active
Type : II
Certificate Number : CEP 2021-387 - Rev 00
Issue Date : 2024-04-05
Type : Chemical
Substance Number : 749
Status : Valid
Registration Number : 306MF10067
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 : 48954-587
Start Marketing Date : 2016-08-24
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 : 39943
Submission : 2024-09-15
Status : Active
Type : II
NDC Package Code : 62158-0010
Start Marketing Date : 2021-12-01
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 : 3507
Submission : 1979-04-27
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-006 - Rev 03
Issue Date : 2008-09-17
Type : Chemical
Substance Number : 749
Status : Valid
Registration Number : 220MF10117
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 : 4711
Submission : 1982-11-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12626
Submission : 1997-08-21
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 : 6290
Submission : 1986-04-21
Status : Inactive
Type : II
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