Alembic Pharmaceuticals receives US FDA Final Approval for Doxycycline Hyclate Tablets USP, 75 mg and 150 mg

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxycycline Hyclate Tablets USP, 75 mg and 150 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Acticlate Tablets, 75 mg and 150 mg, of Almirall, LLC. Doxycycline Hyclate Tablets, 75 mg and 150 mg are indicated for the treatment of certain Rickettsial, sexually transmitted, respiratory tract, bacterial and ophthalmic infections. It is also indicated for anthrax including inhalation anthrax. It is indicated as an alternative treatment for certain infections where Penicillin is contraindicated. It is also indicated as an adjunctive therapy for acute intestinal amebiasis and severe acne and for prophylaxis of malaria.

Doxycycline Hyclate Tablets USP, 75 mg and 150 mg have an estimated market size of US$ 17 million for twelve months ending March 2020 according to IQVIA.

Alembic now has a total of 125 ANDA approvals (111 final approvals and 14 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.910.4 as compared to the previous close of Rs. 896.4. The total number of shares traded during the day was 15927 in over 1827 trades.

The stock hit an intraday high of Rs. 925 and intraday low of 877.5. The net turnover during the day was Rs. 14500131.

Source : Equity Bulls

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