Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
01 1Macsen Labs
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Ataman Kimya
04 2Azico Biophore India Pvt. Ltd
05 2Dishman Carbogen Amcis
06 1EMCO Dyestuff
07 1Riddhesh Pharmachem
08 1Sekisui Medical Co. Ltd
09 1Sichuan Xieli Pharmaceutical
10 1Sisco Research Laboratories
01 1China
02 9India
03 1Japan
04 1Turkey
01 3Active
02 1Inactive
03 8Blank
01 12Blank
01 1217MF10769
02 11Blank
01 1WC-0404
02 1WC-0404A2
03 10Blank
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40119
Submission : 2024-06-25
Status : Active
Type : II
NDC Package Code : 73379-105
Start Marketing Date : 2023-03-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-15
Pay. Date : 2017-01-12
DMF Number : 31299
Submission : 2017-01-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32910
Submission : 2018-06-14
Status : Active
Type : II
NDC Package Code : 61876-0073
Start Marketing Date : 2016-05-16
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 : 32702
Submission : 2018-05-14
Status : Inactive
Type : II
NDC Package Code : 61876-0073
Start Marketing Date : 2016-05-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2020-08-17
Valid Till : 2023-06-22
Written Confirmation Number : WC-0404
Address of the Firm :
NDC Package Code : 69575-4015
Start Marketing Date : 2021-12-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2020-08-17
Valid Till : 2023-06-22
Written Confirmation Number : WC-0404A2
Address of the Firm :
NDC Package Code : 69575-4015
Start Marketing Date : 2021-12-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
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