The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
Gland Pharma Q2 FY2023 consolidated net profit up at Rs. 241.24 Cr
Oncodesign Services (ODS ), with 600 clients in 33 countries and 227 employees worldwide, provides services from target identification to hit-to-lead and lead optimization through to IND filing.
On the Capex front, the company has invested Rs. 416 crore in the first half and it is broadly in line with our guidance for the two years around Rs. 2,000 crore across all the subsidiaries and divisions
Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
A MoU was signed between Ministry of Ayush and Ministry of Tribal Affairs to collaborate in Ayush sector
The newest facility has all the core specialties like Obstetrics and Gynaecology, Orthopaedics, Neurology, Cardiology, Paediatrics, General Surgery, and Urology
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