Shares of Alembic Pharmaceuticals rose by almost 2% to a day’s high of Rs 996.35 on 15 July, after the company received a tentative USFDA approval for its ANDA Selexipag for injection, 1,800 mcg/vial.

This ANDA is similar to Actelion Pharmaceuticals’ Uptravi for injection, at 1,800 mcg/vial. Selexipag is a prostacyclin receptor agonist used to treat pulmonary arterial hypertension. It helps to delay the progression of PAH while also lowering the risk of hospitalisation.

They are the first to file an ANDA for Selexipag injection at 1,800 mcg/vial with a Paragraph IV certification under the Hatch-Waxman Act.

In accordance with the USFDA’s latest notice, Alembic Pharma holds sole first-applicant status for this product. After the final approval, the former company might qualify for 180 days of generic marketing exclusivity in the United States.

The firm has received a cumulative total of 208 ANDA approvals from the USFDA, including 180 final approvals and 28 tentative approvals.

The stock had touched a 52-week high of Rs 1,093.05 on 21 February 2024 and a low of Rs 641.65 on 14 July 2023. Presently, it is 10.8% below its 52-week high and 51.96% above its 52-week low.

At 2:30 PM, the shares of Alembic Pharmaceuticals were trading 1.69% higher at Rs 990.05 on BSE.