Pharma company Lupin said that the US Food and Drug Administration (USFDA) has completed the pre-approval investigation of the company's biotech facility based in Pune, India. The investigation was conducted from 25 September 2024 to 04 October 2024 and was completed with five objections. The company said that it is addressing the objections and will respond to the US FDA within the stipulated time frame. Mumbai-based Lupin is an innovation-based multinational pharmaceutical company.

The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in more than 100 markets in the US, India, South Africa and Asia Pacific (APAC), Latin America (LATAM), Europe and the Middle East.

What is USFDA investigation The USFDA inspects and evaluates regulated facilities to determine a company's compliance with applicable laws and regulations. FDA investigators may investigate conditions they consider objectionable during an inspection. Investigated companies are encouraged to respond in writing within 15 days of the issuance of an FDA-483, FDA-4056, or verbal observation, submitting their corrective action plan with supporting documentation. Share performance On Friday, the company's stock closed at Rs 2,205 with a gain of 0.98 per cent. In the last one year, the company's stock has seen an increase of 91.87 per cent. The 52-week high of the stock is Rs 2,312.