The drug, in the dosage of 750 mg per 5 milliliter, had annual sales of approximately USD 119 million in the US.
It is indicated for the prevention of Pneumocystis jirovecii pneuomonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprimsulfamethoxazole (TMP-SMX).
The suspension is also for the treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMPSMX, the drug maker said.
Separately, the company also said its Nagpur facility passed a pre-approval inspection by the US FDA.
Lupin, one of the world’s biggest makers of generic drugs, sells both branded & generic formulations, biotechnology products and pharmaceutical ingredients globally.
It focuses on cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-infective and NSAID segments of the pharma market.
It is the biggest manufacturer of anti-TB medicines.
As of September, the company was ranked 13th in terms of generics pharmaceutical companies globally in terms of market capitalization and 8th in terms of revenues.
It is also the third largest pharmaceutical player in the US by prescriptions and the fifth largest company in the Indian pharmaceutical market.