Natco Pharma rises after filing ANDA for Bosentan tablets

Natco Pharma rose 0.88% to 551.75 at 9:25 IST on the BSE after the company announced filing of ANDA with the US drug regulator for generic version of Bosentan tablets.

The announcement was made after market hours on Tuesday, 4 June 2019.

Meanwhile, the S&P BSE Sensex was down by 22.58 points, or 0.06% to 40,060.96.

On the BSE, 1272 shares were traded in the counter so far compared with average daily volumes of 18,000 shares in the past two weeks. The stock had hit a high of Rs 555 and a low of Rs 547 so far during the day. It hit a 52-week high of Rs 849 on 12 September 2018 and a 52-week low of Rs 482 on 28 May 2019.

Natco Pharma announced that it has submitted an application for an Abbreviated New Drug Application (ANDA) with Para IV certification with US Food and Drug Administration (FDA) for the generic version of Bosentan 32mg tablets for oral suspension. The ANDA is possibly the sole first-to-file based on the filing date and may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product.

Bosentan 32mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson & Johnson), under the brand Tracleer. Tracleer is indicated for the treatment of pulmonary arterial hypertension.

As per Johnson & Johnson's annual report, for the year ending 2018, Tracleer had registered sales of approximately $268 million in the US market. The 32 mg is one strength that is indicated for pediatric patients.

On a consolidated basis, Natco Pharma's net profit declined 59.7% to Rs 120.80 crore on 40.6% reduction in net sales to Rs 455.70 crore in Q4 March 2019 over Q4 March 2018.

Natco Pharma is engaged in the business of pharmaceuticals which comprises research and development, manufacturing and selling of bulk drugs and finished dosage formulations.

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