Alembic Pharma wins USFDA nod for Doxycycline Capsules

28 Jun 2024 , 05:19 PM

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules, 40 mg.

At the time of writing on June 28, 2024 at 5:16 pm shares of Alembic Pharmaceuticals were trading at ₹880 which is a 0.11% gain than the previous close. The stock has gained a total of 37% in the last one year, and 14% since the beginning of the year.

The approved ANDA is equivalent to the reference listed drug product (RLD), Oracea Capsules, 40 mg, by Galderma Laboratories, L.P.

Doxycycline capsules are specifically for treating inflammatory lesions (papules and pustules) of rosacea in adult patients. The market size for Doxycycline Capsules, 40 mg is estimated at US$ 123 million for the twelve months ending March 2024, according to IQVIA.

Alembic now has a total of 205 ANDA approvals from the USFDA, comprising 179 final approvals and 26 tentative approvals.