Alembic Pharmaceutical, a Rs.3,100 crore pharma major from Vadodara, has received US FDA approval for its ANDA bupropion hydrochloride tablets USP, 75 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Welbutrin tablets of GlaxoSmithKline LLC. Bupropion hydrochloride tablets is indicated for the treatment of major depressive disorder.

These tablets have an estimated market size of US$ 37 million for twelve months ending December 2017 according to IMS. Alembic has a total 72 ANDA approvals (64 final approvals and 8 tentative approvals from US FDA.

Alembic scrip went up by over 20 per cent in the afternoon session to Rs.521.80 on BSE with market capitalisation of Rs.9,837 crore. The scrip touched to its yearly high level at Rs.588 on February 15, 2018.
The financial performance during the full year ended March 2018 remained almost stagnant. Its net profit increased only by 2.5 per cent to Rs.413 crore from Rs.403 crore. Its net sales declined slightly to Rs.3,130 crore from Rs.3,135 crore in the previous year. R&D expenditure declined to Rs.411 crore from Rs.427 crore and worked out to 13 per cent of sales. It received 13 ANDA approvals including 4 tentative approvals during the year and its cumulative ANDA approvals reached at 72. Currently cumulative ANDA filings reached at 134 ANDAs.