CIPLA receives approval from US FDA

CIPLA receives approval from US FDA

Aakash Makhija
/ Categories: Trending, DSIJ News

Cipla Limited announced that it 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’s Adcirca. It is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability. According to IQVIA (IMS Health), Adcirca and its generic equivalents had US sales of approximately US$490 million for the 12-month period ending November 2018. The product is available for shipping immediately.

Cipla is a global pharmaceutical company focused on complex generics catering to respiratory, anti-retroviral, urology, cardiology and CNS segments. Cipla is ranked third largest pharma in India and in the pharma private market in South Africa. The company is also among the most dispensed generic players in the US.

On Thursday, the stock opened at Rs. 537 per share and touched a high/low of 546.60/528.15 per share.


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