US regulator nod for Jubilant's anti-infection drug

Leading Indian drug maker Jubilant Life Sciences Tuesday announced it had received approval of the US Food and Drug Administration (FDA) for its tablets used in treating adults for various infections, including pneumonia.

Bengaluru: Leading Indian drug maker Jubilant Life Sciences Tuesday announced it had received approval of the US Food and Drug Administration (FDA) for its tablets used in treating adults for various infections, including pneumonia.

"Levofloxacin tablets are the generic version of Levaquin of Ortho-McNeil, used for treating infections such as pneumonia, sinusitis, bronchitis, prostatitis, urinary tract and inhalational anthrax," the Noida-based firm said in a statement here.

According to IMS Health, the market size for Levofloxacin tablets is estimated to be $28 million (Rs.179 crore) per annum.

The company, which had 806 filings for formulations till March 31, got approval for 368 of them from various regions worldwide, including 72 from FDA.

As an integrated drug maker, Jubilant manufactures and supplies active pharmaceutical ingredients, solid dosage formulations, specialty pharmaceuticals and life science ingredients. The company also provides services in contract manufacturing and drug discovery solutions to global firms from its 10 production units in India, Canada and the US.

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