FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

Renalys Pharma reports major phase III success for Sparsentan in Japanese IgA nephropathy patients

The study, which enrolled 35 Japanese patients, evaluated the percent change from baseline in the 24-hour urine protein-to-creatinine ratio

Solara’s Mangalore facility clears FDA inspection with VAI status

Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification

Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub

Sai Life Sciences completes Phase II of production block 11 at Bidar

With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL

Hikal reports Q1 FY26 consolidated loss of Rs. 22.4 Cr

Hikal has reported total income of Rs. 381.4 crores during the period ended June 30, 2025

Briefs: Ami Organics and Panacea Biotec

Ami Organics’ Ankleshwar Unit II gets GMP compliant by PMDA Japan

SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483

Glenmark Life Sciences rebranded as Alivus Life Sciences

The change is reflective of the company’s evolving vision aimed at further strengthening its global presence and a commitment to providing innovative solutions in the API and CDMO space

Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara

The biosimilar Ustekinumab has been developed and manufactured by the company