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Cipla receives final approval for generic version of Eli Lilly & Co’s Adcirca

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Income from operations reported at ₹ 4008 crore in third quarter

Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Tadalafil Tablets 20mg from the United States Food and Drug Administration (US FDA). Cipla’s Tadalafil Tablets 20mg is AB-rated generic therapeutic equivalent version of Eli Lilly & Co’s Adcirca. It is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.

According to IQVIA (IMS Health), Adcirca and its generic equivalents had US sales of approximately $490M for the 12-month period ending November 2018. The product is available for
shipping immediately.

The company also posted its Q3 results. Income from operations was reported at 4008 crore, EBITDA was at 720 crore and a PAT of 332 crore.

“This quarter, our US business has delivered strongly as a result of scale-up of new launches. We are tracking well on our guidance on limited competition launches and ANDA approvals. Overall, challenges in this quarter were along expected lines and we remain optimistic as we enter FY’20. Our plan to drive YoY growth from the coming quarters in on track. Our key focus markets remain growth anchors, we have built further on our existing specialty pipeline, and we continue to explore innovative ways of going beyond the pill to meet unmet patient needs,” said Umang Vohra, MD and Global CEO, Cipla.

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