Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbidopa and Levodopa Extended-Release Tablets USP, 2.5 mg/100 mg and 50 mg/200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sinemet CR Tablets, 25 mg/100 mg and 50 mg/200 mg, of Merck Sharp & Dohme Corp. Carbidopa and Levodopa Extended-Release Tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Carbidopa and Levodopa Extended-Release Tablets USP, 25 mg/100 mg and 50 mg/200 mg have an estimated market size of US$ 24 million for twelve months ending December 2018 according to IQVIA.
Alembic now has a total of 95 ANDA approvals (83 final approvals and 12 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.511.45 as compared to the previous close of Rs. 518.5. The total number of shares traded during the day was 4509 in over 183 trades.
The stock hit an intraday high of Rs. 521.95 and intraday low of 510. The net turnover during the day was Rs. 2319982.