Strides Pharma Singapore arm bags USFDA nod for HIV-1 drug

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Atripla tablets of Gilead Sciences LLC.

According to IQVIA, the EET tablet has a market opportunity in the US of approximately $7.5 million. The product will be manufactured at the company's facility in Bengaluru.

Strides' EET tablets belong to a class of medication knows as antiretrovirals. This fixed-dose triple-drug combination medication is indicated for treatment of HIV-1 infection in adult patients weighing atleast 40 kgs.

Menawhile, Strides Pharma Global Pte., Singapore had received approval from the United States Food & Drug Administration (USFDA) for Icosapent Ethyl capsules. Strides' Icosapent Ethyl capsules are used as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vascepa of Amarin. As per per IQVIA, the Icosapent Ethyl capsules have a market size of about $1.3billion. The product will be manufactured at the company's facility in Bengaluru.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which over 230 ANDAs have been approved. The company has set a target to launch around 60 new products over three years in the US.

Bengaluru-based Strides Pharma Science is a global pharmaceutical company. The company mainly operates in the regulated markets and has an in Africa for Africa strategy and an institutional business to service donor-funded markets. The company's global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York).

The company reported a consolidated net loss of Rs 7.11 crore in the quarter ended June 2023 as against net loss of Rs 135.89 crore during the previous quarter ended June 2022. Net sales declined 1.07% to Rs 929.99 crore in Q1 FY24 over Q1 FY23.

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