Alembic Pharmaceuticals Announces USFDA Final Approval For Bosentan Tablets, 62.5 mg And 125 mg

Alembic Pharmaceuticals Limited (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bosentan Tablets, 62.5 mg and 125 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tracleer Tablets, 62.5 mg and 125 mg, of Actelion Pharmaceuticals Limited. Bosentan Tablets indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1 ).

Bosentan Tablets, 62.5 mg and 125 mg have an estimated market size of US$ 68 million for twelve months ending September 2019 according to IQVIA.

Alembic has a cumulative total of 114 ANDA approvals (102 final approvals and 12 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.590.05 as compared to the previous close of Rs. 589.75. The total number of shares traded during the day was 9424 in over 813 trades.

The stock hit an intraday high of Rs. 596 and intraday low of 583. The net turnover during the day was Rs. 5548686.-Equity Bulls