The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Ivacaftor oral granules of strengths 25 mg, 50 mg, and 75 mg per unit dose packet, ...

This ANDA has been found to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Symtuza tablets, 800 mg/150 mg/200 mg/10 mg of Janssen Products, LP. Lupin is the ...

Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets are therapeutic equivalents of Symtuza Tablets 800 mg/150 mg/200 mg/10 mg brand of Janssen Products, LP. According to IQVIA ...

Pharma major Lupin Ltd on Thursday said it has received tentative approval from the US health regulator to market its generic version of Ivacaftor oral granules used in treatment of cystic fibrosis.

Ipratropium bromide nasal solution (nasal spray), 0.06% (Atrovent) had estimated annual sales of USD 42 million in the US (IQVIA MAT November 2024). Lupin Limited is a global pharmaceutical leader ...

We remain committed to enhancing compliance and quality standards across all our manufacturing sites,” Nilesh Gupta, Managing Director, Lupin said ... biotechnology products, and APIs in over ...