Alembic Pharmaceuticals announces USFDA Final Approval for Doxycycline Capsules, 40 mg

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules, 40 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Oracea Capsules, 40 mg, of Galderma Laboratories, L.P. (Galderma). Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. Refer label for a detailed indication.

Doxycycline Capsules, 40 mg have an estimated market size of US$ 123 million for twelve months ending March 2024 according to IQVIA.

Alembic has a cumulative total of 205 ANDA approvals (179 final approvals and 26 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 876.40 as compared to the previous close of Rs. 879.60. The total number of shares traded during the day was 8439 in over 1312 trades.

The stock hit an intraday high of Rs. 900.00 and intraday low of 871.00. The net turnover during the day was Rs. 7455751.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA FinalApproval DoxycyclineCapsules