Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
01 1Macsen Labs
02 1Minakem
03 1Minakem (formerly Delmar Chemicals)
04 1Biophore India Pharmaceuticals Pvt Ltd
05 1Jai Radhe Sales
06 1Abbey Color
07 1EASTMAN KODAK
08 1Guangzhou Tosun Pharmaceutical
09 2Icrom
10 1Unipex
01 1Canada
02 1China
03 2France
04 3India
05 2Italy
06 2U.S.A
01 6Active
02 1Inactive
03 4Blank
01 1Valid
02 10Blank
01 11Blank
01 11Blank
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38960
Submission : 2023-09-27
Status : Active
Type : II
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 :
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DMF Number : 18791
Submission : 2005-09-16
Status : Active
Type : II
NDC Package Code : 11712-375
Start Marketing Date : 2004-08-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39334
Submission : 2023-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29144
Submission : 2015-03-05
Status : Active
Type : II
Certificate Number : R1-CEP 2017-121 - Rev 00
Issue Date : 2023-07-03
Type : Chemical
Substance Number : 1213
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-21
Pay. Date : 2024-02-07
DMF Number : 39362
Submission : 2024-02-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-03
Pay. Date : 2014-05-01
DMF Number : 19777
Submission : 2006-09-18
Status : Active
Type : II
NDC Package Code : 45633-100
Start Marketing Date : 1996-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER, FOR SOLUTION (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9094
Submission : 1991-05-03
Status : Inactive
Type : II
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