Shares of Indoco Remedies fell nearly 3 per cent on Friday morning after the United States Food and Drug Administration (USFDA) issued four observations for the company’s Goa facility.
The FDA conducted an inspection of the company's solid oral formulation facility (Plant I) in Goa between October 12 and October 18, 2023, specifically in relation to two drug product applications (ANDAs) submitted from this unit, as reported by the company.
At 11:00 am, Indoco Remedies was trading at Rs 337, down by over 3 per cent or 12 points on the National Stock Exchange (NSE).
Indoco Remedies is a fully integrated and research-oriented pharma company based in Mumbai.
In the second quarter of fiscal 2024, Indoco recorded a 13 per cent increase in standalone revenue, amounting to Rs 465.2 crore against Rs 413.2 crore reported in the previous quarter (Q1FY24).
The company's standalone profit after tax (PAT) declined 33 per cent year-on-year. In the corresponding quarter of the previous year, the company's PAT stood at Rs 49.64 crore, as per information disclosed in the company's exchange filing.
EBITDA to net sales for the quarter came in at 15.6 per cent at Rs 72.4 crore as against 15.2 per cent at Rs 62.9 crore in the previous quarter. Profit after tax (PAT) stood at Rs 32.9 crore, up 28 per cent QoQ, compared to Rs 25.7 crore in June quarter.
“Our Q2 performance is primarily driven by international business, API business and sustained performance by domestic business," said Aditi Panandikar, Managing Director, Indoco Remedies.
Following the preapproval inspection, the American drug regulatory authority issued a "Form 483" with "four observations," as informed by the company.
Regarding the FDA's interjection, the company affirmed its commitment to addressing the observations thoroughly and within the prescribed timeframe.
Earlier this year, the share price of Indoco Remedies had reached its 52 week high, hitting Rs 423.10 price level.