KEY PRODUCTS
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
01 1Aarti Pharmalabs
01 1PALBOCICLIB
01 1India
01 1Active
01 1Complete
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
GDUFA
DMF Review : Complete
Rev. Date : 2025-07-09
Pay. Date : 2025-05-09
DMF Number : 41388
Submission : 2025-04-14
Status : Active
Type : II
20
Aarti Pharmalabs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
One of their notable products is PALBOCICLIB, with a corresponding US DMF Number 41388.
Remarkably, this DMF maintains an Active status since its submission on April 14, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 09, 2025, and payment made on May 09, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
