Alembic Bags U.S. FDA Nod For Vadodara Plant, Hypertension Drug; Shares Volatile

Shares of Alembic Pharmaceuticals Ltd. reversed losses to trade nearly 2% higher in intraday trade after the company received the nod for its Vadodara plant and its drug to treat hypertension. The stock erased gains to close little changed in a weak market.

Alembic Pharma successfully completed the U.S. FDA remote regulatory assessment for its bioequivalence facility, bio-analytical division at Vadodara, without any observations, the maker of bulk and finished drugs said in an exchange filing on Monday. The assessment was conducted between Aug. 22 and Aug. 26.

The company also received the final approval from the U.S. drug regulator for Chlorthalidone tablets USP (25 mg and 50 mg) used for treating hypertension. The approved filing is therapeutically equivalent to Hygroton Tablets of Sanofi Aventis.

The drug has an estimated market size of $37 million for 12 months ended June 2022, according to IQVIA. The company has an aggregate of 171 ANDA approvals from U.S. FDA (both final and tentative)

Of the 18 analysts tracking the company, two maintain 'buy', six suggest 'hold' and 10 recommend 'sell', according to Bloomberg data. The implied return potential of the stock is 4.4%.