Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Doxycycline Hyclate Delayed-Release Tablets.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Doryx Tablets of Mayne Pharma International.
Doxycycline Hyclate Delayed-Release Tablets are indicated' to reduce the development of drug-resistant bacteria.
Doxycycline Hyclate Delayed-Release Tablets have an estimated market size of US$10 million for twelve months ending September 2021 according to IQVIA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
The drug maker's consolidated net profit dropped 49.22% to Rs 169.29 crore on a 11.31% fall in sales to Rs 1,292.32 crore in Q2 FY22 over Q2 FY21.
The scrip rose 0.27% to currently trade at Rs 811.75 on the BSE.
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