Ipca Laboratories has announced that the US Food and Drug Administration (US FDA) has completed an inspection of its Active Pharmaceutical Ingredients (APIs) manufacturing plant in Tarapur, Palghar (Maharashtra). The inspection was conducted between December 1–5, 2025 and concluded with the issuance of a Form 483 containing three observations.  

The company noted that it will submit a detailed response within the prescribed timeline and will work closely with the regulator to resolve these issues at the earliest.

The company reaffirmed that it takes the quality and compliance issues with utmost importance and remains committed to maintaining the highest standards of quality and compliance across all its manufacturing facilities.

Ipca manufactures more than 350 formulations and 80 APIs across multiple therapeutic areas. The company is also among India’s leading exporters of APIs, supplying to over 70 countries, with a total of 15 API and 11 formulations facilities globally.

Its manufacturing leadership extends across Atenolol (anti-hypertensive), Chloroquine Phosphate (anti-malarial), Chlorthalidone (diuretic), Furosemide (diuretic), Hydroxychloroquine Sulphate (DMARD), Losartan (anti-hypertensive), Metoprolol Succinate (anti-hypertensive), Metoprolol Tartrate (anti-hypertensive), Pyrantel Salts (anthelmintic), and Propranolol (anti-hypertensive).