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LUPIN a Pharma major received approval Tadalafil Tablets USP, 20 mg from the USFDA

Lupin announced that it has received approval for its Tablets USP, 20 mg from the Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s Adcirca Tablets, 20 mg.

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Lupin receives USFDA approval for Tadalafil Tablets

Pharma major Lupin announced that it has received tentative approval for its Tadalafil Tablets USP, 20 mg from the USFDA to market a generic version of Eli Lilly and Company’s (Lilly) Adcirca Tablets, 20 mg.

Lupin’s Tadalafil Tablets USP, 20 mg is the generic version of Lilly’s Adcirca Tablets, 20 mg. It is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.

Adcirca Tablets, 20 mg, had annual sales of ~$503.8mn in the US, as per IQVIA MAT September 2018 data.

Lupin Ltd is currently trading at Rs.848.05 up by Rs.5.25 or 0.62% from its previous closing of Rs.842.80 on the BSE.

The scrip opened at Rs.841 and has touched a high and low of Rs.855 and Rs.840.50 respectively.

Lupin manufacturers branded and generic formulations, biotechnology products, and APIs. It generated 32% revenue from the US business; 31% from India; 16% from APAC; 7% from EMEA (Europe, Middle-East and Africa); 4% from LATAM and RoW markets; and 9% from API in Q2FY19. In the domestic business, the company largely derives revenue from chronic therapies, accounting for 65% of its domestic revenue.

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