SMS Pharma clears USFDA inspection at Vizag facility with minor observation
SMSPHARMA · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
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SMS Pharmaceuticals announced successful completion of USFDA inspection at its 3,000 KL API manufacturing facility in Visakhapatnam, conducted December 8 to 12, 2025. The inspection ended with one minor procedural observation in Form 483, with no data integrity concerns. The company will respond within the stipulated time. This was the 4th inspection at the Vizag facility and the 12th across all manufacturing sites.
Positive for the stock. Confirms regulatory compliance, supports continued API exports to the US. No material impact from the minor observation.