ZYDUSLIFE

ZYDUS LIFESCIENCES : USFDA INSPECTION CONCLUDES AT BIOLOGICS INJECTABLE PLANT WITH 7 OBSERVATIONS ⚠️🔬 • 🏭 USFDA conducts GMP surveillance inspection at Zydus' Unit 9 — Biologics Injectable facility at Zydus Biotech Park, Changodar, Ahmedabad from April 27 to May 5, 2026 • ⚠️ Inspection concludes with 7 observations | No data integrity related observations — a relatively positive aspect • 🤝 Company commits to working closely with USFDA to address all observations expeditiously 🔴 Impact: Negative (7 observations from a USFDA GMP inspection is a meaningful regulatory concern for the Biologics plant — resolution timeline and nature of observations will be key; absence of data integrity issues provides some relief but market may react cautiously until responses are filed)