Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.

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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 : 40164
Submission : 2024-06-27
Status : Active
Type : II
NDC Package Code : 73379-107
Start Marketing Date : 2025-08-25
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-04-15
Pay. Date : 2025-03-11
DMF Number : 36647
Submission : 2021-12-30
Status : Active
Type : II
Reliable Spanish CDMO Delivering High-Quality APIs and Intermediates with Excellence, Flexibility, and Regulatory Compliance.
Sigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.
NDC Package Code : 58272-202
Start Marketing Date : 2009-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-12-05
Pay. Date : 2021-11-30
DMF Number : 19601
Submission : 2006-07-13
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2025-01-03
Pay. Date : 2024-11-26
DMF Number : 40605
Submission : 2024-09-27
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-22
Pay. Date : 2023-11-09
DMF Number : 38104
Submission : 2023-10-31
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 294
Submission : 1958-04-09
Status : Inactive
Type : II

56
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