Granules India receives ANDA approval for Levetiracetam Tablets

Granules now has a total of 58 ANDA approvals from US FDA

Euroapi plans initiatives to support production of APIs in France and Europe

Total investments could reach €70 million, of which approximately 15% in R&D and 85% in capex, that would be deployed from 2026

Merck gets favourable verdict in patent infringement lawsuit related to Bridion

Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.

Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets

Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States

Granules India received ANDA approval for Metoprolol Succinate ER Tablets

Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.

Biostar announces first patient enrolled for Phase 1 study of Utidelone Capsule

UTD2 is the world's first oral epothilone microtubule inhibitor

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities

Milla receives first cycle FDA approval for Dexmedetomidine Hydrochloride Injection

Indoco's Baddi facility receives EUGMP certification from Health Authority of Germany

The EU certification will support supplies of drug products registered in Europe, from this manufacturing site

Asence Pharma commences new plant at Ranoli, Vadodara

The new API plant is set up to meet all domestic and international regulatory standards and will manufacture niche molecules that have a global requirement