KEY PRODUCTS
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
01 1Macsen Labs
01 1METHYLENE BLUE USP
01 1India
01 1Active
01 1Complete
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-18
Pay. Date : 2023-08-28
DMF Number : 35095
Submission : 2020-08-17
Status : Active
Type : II
20
Macsen Drugs, based in India, is a pharmaceutical company that stands out with its certifications from WHO-GMP.
They are recognized for Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
One of their notable products is METHYLENE BLUE USP, with a corresponding US DMF Number 35095.
Remarkably, this DMF maintains an Active status since its submission on August 17, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 18, 2023, and payment made on August 28, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
