Alembic Pharmaceuticals receives US FDA· Final Approval for Entacapone Tablets USP, 200 mg

Alembic Pharmaceuticals Limited (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Entacapone Tablets USP, 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Comtan Tablets, 200 mg, of Orion Corporation. Entacapone Tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease.

Entacapone Tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021 according to IQVIA.

Alembic has received year to date (YTD) 17 approvals (13 final approvals and 4 tentative approvals) and a cumulative total of 156 ANDA approvals (136 final approvals and 20 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 820.50 as compared to the previous close of Rs. 816.20. The total number of shares traded during the day was 46600 in over 1868 trades.

The stock hit an intraday high of Rs. 826.90 and intraday low of 800.00. The net turnover during the day was Rs. 38229715.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 ANDA Approval USFDA EntacaponeTablets