Alembic Pharma jumps on USFDA nod for antibacterial drug

Alembic Pharmaceuticals rose 3.47% to Rs 875 after the company said it received US drug regulator's final approval for doxycycline hyclate tablets USP, 100 mg.

Alembic Pharmaceuticals on Friday (15 May 2020) announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) doxycycline hyclate tablets USP 100mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Vibra-Tabs, 100mg of Pfizer, Inc.

This medication is used to treat a wide variety of bacterial infections, including those that cause acne. This medication is also used to prevent malaria.

The drug has an estimated market size of $53 million for twelve months ending December 2019 according to IQVIA. Alembic has a cumulative total of 121 ANDA approvals (108 final approvals and 13 tentative approvals) from USFDA.

On a consolidated basis, the pharmaceutical company's net profit rose 88.10% to Rs 233.25 crore on a 30.19% increase in the net sales to Rs 1,206.83 crore in Q4 March 2020 over Q4 March 2019. The result was announced on 23 April 2020.

Alembic Pharmaceuticals is engaged developing formulations and active pharmaceutical ingredients (API).

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