Briefs: Zydus, Advanced Enzyme Technologies, Link Pharma Chem and ANVISA

ANVISA issues CGMP to Concord Biotech’s Unit I

Supriya Lifesciences received GMP certification from ANVISA Brazil

The clearance of this audit marks the successful registration of 8 APIs with CADIFA

Gufic Biosciences receives TGA Australia and ANVISA Brazil approval for Parecoxib 40mg injection

Parecoxib Sodium is the first parenteral selective COX-2 inhibitor available for clinical use in pain management

Caplin Point Lab's subsidiary receives nod from Brazil's ANVISA for sterile injectable manufacturing site

The approval allows it to market its products in the country

Singapore clears AI bladder cancer detection tool

CystoSmart, an AI tool designed to detect bladder tumors during screening and surveillance cystoscopy, is brand-agnostic and works with flexible, rigid, and single-use scopes

Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia

Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification

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

Briefs: Alembic Pharmaceuticals and Tyche Industries

Alembic receives EIR from USFDA for facility at Panelav

iPHEX 2025: Global regulatory conclaves to highlight India’s role in shaping global health

This year’s edition will witness participation of over 700 Indian exporters showcasing their products and services; 500+ overseas delegates representing more than 120 countries; 20,000 domestic visitors; and 8,000+ B2B meetings

Enable injections receives enFuse system approval in Brazil and UK registration