Alembic Pharmaceuticals Limited (Alembic) today announced its wholly owned subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Glycopyrrolate Tablets USP, 1 mg and 2 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Robinul and Robinul Forte Tablets, 1 mg and 2 mg, of Casper Pharma LLC (Casper Pharma). Glycopyrrolate Tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.
Glycopyrrolate Tablets USP, 1 mg and 2 mg have an estimated market size of US$ 15 million for twelve months ending December 2017 according to IQVIA.
Alembic has a cumulative total of 81 ANDA approvals (68 final approvals and 13 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.612.4 as compared to the previous close of Rs. 616.7. The total number of shares traded during the day was 4016 in over 311 trades.
The stock hit an intraday high of Rs. 636.5 and intraday low of 612.4. The net turnover during the day was Rs. 2508819.