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 1Jai Radhe Sales
04 1Abbott Laboratories
05 1Amoli Organics
06 1Biotechnica DWC
07 1Harman Finochem
08 1Mac-Chem Products (India) Pvt.Ltd
09 1Mankind Pharma
10 1Micro Orgo Chem
11 1Nycomed Austria GmbH
12 1PROVENTUS LIFE SCIENCES PVT LTD
13 1Phlow Corporation
14 2SEQUENT SCIENTIFIC LTD
15 1Solara Active Pharma Sciences
16 1Takeda Pharmaceutical
17 1Tecoland Corporation
18 1Xian Libang Pharmaceutical Co.,Ltd
19 1Zydus Lifesciences
20 1Zydus Takeda Healthcare
01 1Algeria
02 1Austria
03 1Canada
04 1China
05 1France
06 12India
07 1Japan
08 3U.S.A
01 7Active
02 3Inactive
03 11Blank
01 3Valid
02 18Blank
01 1304MF10080
02 20Blank
01 1WC-0044
02 1WC-0204
03 1WC-0275
04 1WC-0294
05 1WC-204
06 2WC-294
07 14Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-02
Pay. Date : 2018-02-12
DMF Number : 23224
Submission : 2009-10-29
Status : Active
Type : II
NDC Package Code : 11712-830
Start Marketing Date : 2006-08-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-02
Pay. Date : 2023-02-16
DMF Number : 37095
Submission : 2022-12-15
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-15
Pay. Date : 2017-10-06
DMF Number : 31986
Submission : 2017-10-11
Status : Active
Type : II
Registration Number : 304MF10080
Registrant's Address : 107-A, Vinay Bhavya Complex, 159-A, C. S. T Road, Kalina, Santa Cruz (East), Mumbai-400 098, Maharashtra, India
Initial Date of Registration : 2022-05-25
Latest Date of Registration : --
Date of Issue : 2022-06-06
Valid Till : 2025-07-21
Written Confirmation Number : WC-0044
Address of the Firm :
NDC Package Code : 66064-1028
Start Marketing Date : 2017-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-31
Pay. Date : 2014-03-18
DMF Number : 22892
Submission : 2009-06-24
Status : Active
Type : II
Certificate Number : CEP 2013-210 - Rev 01
Issue Date : 2024-05-30
Type : Chemical
Substance Number : 248
Status : Valid
Date of Issue : 2021-08-06
Valid Till : 2024-03-04
Written Confirmation Number : WC-0294
Address of the Firm :
NDC Package Code : 72643-002
Start Marketing Date : 2011-12-01
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 : 25440
Submission : 2011-10-31
Status : Active
Type : II
Certificate Number : CEP 2012-025 - Rev 03
Issue Date : 2024-07-17
Type : Chemical
Substance Number : 248
Status : Valid
Date of Issue : 2021-01-22
Valid Till : 2023-08-01
Written Confirmation Number : WC-0275
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-08-29
Pay. Date : 2022-08-18
DMF Number : 37245
Submission : 2022-07-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7365
Submission : 1988-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22807
Submission : 2009-05-15
Status : Inactive
Type : II
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