Alembic Pharmaceuticals said the USFDA has permitted it to sell antibiotic doxycycline in the US market.
Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, are considered a medium sized drug from a market perspective and had sales of US$ 80 million in 2017, according to IQVIA.
It is sold by Pfizer under thebrand Vibramycin.
Doxycycline is indicated for a wide variety of bacterial infections, including those caused by several gram-negative as well as gram-positive microorganisms.
The drug is also used as preventive medicine against malaria due to Plasmodium Falciparum in short-term travelers to areas with chloroquine and pyrimethaminesulfadoxine resistant strains.
Doxycycline may also be a useful adjunctive therapy in severe acne and in acute intestinal amebiasis, the company added.
Alembic said it now has 73 generic drug approvals in the US, including 8 tentative approvals.
Alembic Pharmaceuticals, established in 1907, is headquartered in India. It manufactures and markets generic pharmaceutical products all over the world.
Alembic is also present in the branded generics market in India and has a marketing workforce of over 5,000.