Unichem Laboratories has received Tentative Approval for its Abbreviated New Drug Application (ANDA), Tadalafil Tablets, 2.5 mg, 5 mg 10 mg and 20 mg from the United States Food and Drug Administration (USFDA) for a generic version of ELI LILLY's Cialis, 2.5 mg, 5 mg, 10 mg and 20 mg.
The company's Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED) and treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) and the treatment of ED and the signs and symptoms of BPH (ED/BPH).
Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world.