Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Doxycycline capsules.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Oracea capsules, of Galderma Pharmaceuticals, L.P.Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
According to IQVIA, Doxycycline capsules have an estimated market size of $123 million for the twelve months ending March 2024.
Alembic has a cumulative total of 205 ANDA approvals (179 final approvals and 26 tentative approvals) from USFDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.
The company reported 16.78% increase in consolidated net profit to Rs 178.21 crore on 7.85% rise in revenue from operations to Rs 1,516.98 in Q4 FY24 over Q4 FY23.
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