USFDA approval sends this multibagger pharma stock to 52-week high

Shilpa Medicare shares hit 52-week high: Shares of pharmaceutical company Shilpa Medicare climbed 9 per cent to hit a 52-week high of Rs 798 during intra-day deals on the BSE on Tuesday. The northward surge in the stock price is attributed to the news that the company has received approval from the US Food and Drug Administration (USFDA) for its product, 'Bortezomib Injection NDA 212782'.

In an exchange filing, Shilpa Medicare stated, "This is the first 'liquid' injection for Bortezomib, approved for both subcutaneous and intravenous administration by the USFDA. The injection is ready to use for subcutaneous administration, offering significant advantages to healthcare providers."

"The injection has to be diluted for intravenous use. The reference product, Velcade®, is a lyophilized injection that requires reconstitution prior to administration. Bortezomib Injection, a proteasome inhibitor, contains bortezomib, which is an antineoplastic agent. This NDA provides for the use of Bortezomib Injection for the treatment of adult patients with multiple myeloma and adult patients with mantle cell lymphoma," the company said in a regulatory filing on the BSE.

Vishnukant Bhutada, Managing Director of Shilpa Medicare, said, "This second NDA approval in the US market from our novel injectable portfolio is a testament to our capabilities and commitment to introducing patient-centric solutions that enhance compliance and ease of administration. I am very pleased to see that our relentless endeavour and self-belief in investing in various value-added products across different segments have started paying off, with monetization opportunities being created in each of the segments, laying a stronger foundation for the future.”

Shilpa Medicare is an Indian pharmaceutical company that develops, manufactures, and markets active pharmaceutical ingredients (APIs) and formulations for generic medications. The company has a market capitalization of Rs 7,448.24 crore on the BSE and is a constituent of the BSE Smallcap index.

Shares of Shilpa Medicare have offered a multibagger return year-to-date, with a rally of a whopping 137.19 per cent, as reflected by BSE analytics.

The company's shares have a 52-week range of Rs 798 to Rs 296.45 on the BSE.

At around 2:32 PM, Shilpa Medicare shares were trading at Rs 761.65, up 4 per cent from its previous close of Rs 732.60 on the BSE. On the NSE, the smallcap stock was seen at Rs 760, up 3.79 per cent from its previous close of Rs 731.55. At the same time, nearly 15.90 lakh shares of Shilpa Medicare were exchanged, with a total value of nearly Rs 122.59 crore on the NSE.