Ipca Laboratories' Tarapur API plant receives US FDA Form 483 with three observations

Ipca Laboratories Ltd on Friday (December 5) announced that the US Food and Drug Administration (US FDA) has issued a Form 483 with three observations following its inspection of the company's Active Pharmaceutical Ingredients (APIs) manufacturing facility at Tarapur in Palghar, Maharashtra.

The inspection was carried out from December 1, 2025, to December 5, 2025.

According to the company, the observations were shared at the conclusion of the inspection. Ipca Laboratories stated that it will submit a comprehensive response to the US FDA within the stipulated timeline. The company added that it will work closely with the agency to address and resolve the issues raised.

Also Read: IPCA Labs Q4 Results: Revenue and margin grow from last year; dividend announced

Ipca Laboratories said it accords utmost importance to quality and compliance and remains committed to maintaining high standards across all its manufacturing facilities.

Second Quarter Results

IPCA Laboratories reported a 23.1% year-on-year (YoY) rise in consolidated net profit to ₹282.6 crore for the quarter ended September 30, 2025, compared to ₹229.4 crore in the same period last year.

The company’s revenue grew 8.6% YoY to ₹2,556.5 crore, supported by steady growth across both domestic and export markets. EBITDA increased 23.5% YoY to ₹545.5 crore, while margins expanded to 21.33% from 18.75% in the year-ago period.

Also Read: IPCA Labs Q1 Results: Profit up 21% YoY, exports buoy growth despite margin dip

Consolidated net total income stood at ₹2,584.36 crore, reflecting a 9% growth from the previous year. The company’s Indian formulations segment grew 8% YoY to ₹1,018.9 crore, while export income rose 7% to ₹813.65 crore, highlighting broad-based operational strength.