Cipla: Subsidiary receives USFDA nod for Ambrisentan tablets

Cipla with its subsidiary, Cipla USA has received approval for ANDA for Ambrisentan Tablets from the US drug regulator. The shares of the company were trading in red in the morning session. 

The United States Food and Drug Administration (USFDA) has given the final approval for the Abbreviated New Drug Application (ANDA) for Ambrisentan Tablets 5mg and 10mg. The tablets are indicated to treat pulmonary arterial hypertension (PAH), improve exercise ability and delay clinical deterioration. 

Ambrisentan is AB-rated generic therapeutic equivalent version of Gilead’s Letairis. The US sales of Letairiss Tablets USP stood at US$943 million in 2018. 

Also, Cipla's wholly-owned subsidiary, Cipla Medpro South Africa has completed the transaction and acquires 30 per cent stake in Brandmed. Out of the total upfront cash consideration payment of (ZAR - South African Rand) ZAR 65 million, ZAR 50 million has been paid and balance will be paid over a period of next 12 months. 

On Tuesday, the shares of Cipla opened at Rs. 568.55 against Monday’s close of Rs. 568.45. At 9:50 hours, the shares were trading at Rs. 561.50, down by 1.22 per cent. It reached an intraday high of Rs. 570.60 and an intraday low of Rs. 562.85 per share on the BSE. The 52-week high stood at Rs. 678 and 52-week low was at Rs. 483.75 per share on the BSE. 

Meanwhile, the BSE Sensex was quoting 38,829.36, down by 0.61 per cent.