Suven Pharma hits record high on USFDA's 'VAI' tag to Hyderabad facility

Suven Pharmaceuticals share price surged up to 3.67 per cent, hitting their all time high at Rs 1,245 per share on the BSE on Monday. This came after the company on Sunday disclosed that it received an ‘VAI’ tag for its subsidiary’s Hyderabad manufacturing facility.

The inspection was carried out by the United States Food & Drug Administration (US FDA) at the formulations manufacturing facility of Casper Pharma, a wholly owned subsidiary of the Suven Pharmaceuticals, located in Hyderabad.

“We are pleased to inform you that we have received the Establishment Inspection Report (EIR). The US FDA has categorised the inspection as ‘Voluntary Action Indicated’ (VAI) and has deemed it as ‘closed’,” the company said in an exchange filing on Sunday.

According to the USFDA A ‘VAI’ classification means that while an inspection identifies some objectionable conditions or practices, the agency is not taking or recommending any formal administrative or regulatory actions. Instead, the FDA has determined that the facility can address and correct these deficiencies on its own.

The US FDA had conducted the inspection of Casper Pharma from July 8 to July 12, 2024. Following the inspection, a Form 483 was issued with two procedural observations.

In the April-June quarter of financial year 2024-25 (Q1FY25), Suven Pharmaceuticals reported a 49.6 per cent year-on-year (YoY) decline in net profit, totaling Rs 60.8 crore. In the same quarter last year, Suven Pharmaceuticals recorded a net profit of Rs 120.6 crore.

The company's revenue from operations decreased by 33.6 per cent to Rs 230.7 crore in Q1FY25, compared to Rs 347.6 crore in the corresponding period of the previous fiscal year, primarily due to the lumpy nature of the business.

The company has a total market capitalisation of Rs 30,671.26 crore. Its shares are trading at a price to earnings multiple of 124.36 times with an earning per share of Rs 9.65 per share.

At 09:30 AM; the share price of the company was trading 0.85 per cent higher at Rs 433.50. By comparison, the BSE Sensex was trading 0.24 per cent lower at 80,986 levels.

Suven Pharmaceuticals, established in 2018, is a bio-pharmaceutical company specialising in the development and manufacturing of new chemical entity (NCE) intermediates, active pharmaceutical ingredients (APIs), specialty chemicals, and formulated drugs. As a contract development and manufacturing organisation (CDMO), SPL supports global pharmaceutical, biotechnology, and chemical companies in their NCE development efforts.