Unichem Laboratories on Tuesday said it has received a tentative ANDA approval from the USFDA for tadalafil tablets: 2.5 mg, 5 mg, 10 mg and 20 mg. The tablets are indicated for the treatment of erectile dysfunction (ED), and the signs and symptoms of benign prostatic hyperplasia (BPH). Unichem had earlier said it will pay Eli Lily a royalty of 5 per cent on the net sales of the generic tadalafil till the expiry of the global pharma firm’s patent on April 26, 2020.

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