Sigachi Industries gets ToR approval for API and specialty chemicals manufacturing facility in Andhra Pradesh

The project will be instrumental in enhancing the company's API manufacturing capacity and global reach

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received 1 (One) observation in the Form-483

Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa

Zydus receives EIR for the API manufacturing facility at Ankleshwar

Aayush Wellness to form subsidiary in Singapore to drive Southeast Asia expansion

This strategic expansion marks a significant step in the company's global growth strategy

Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets

Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)

Linerixibat new drug application accepted for review by the USFDA for cholestatic pruritus in patients with PBC

If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference

Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy

Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with Spinal Muscular Atrophy (SMA)

iNGENu CRO, Quantum BioPharma to launch Australian trial for chronic nociplastic pain in MCAS patients

The trial targets MCAS/MCAD, an under-recognized, debilitating condition with an unknown cause and no cure

Zydus to acquire Agenus’ US manufacturing facilities, forays into global biologics CDMO business

Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg

Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)