Lupin surges after USFDA approval for Hydrocodone Bitartrate and Acetaminophen tablets

Lupin’s US arm Gavis has received approval from the US health regulator to market Hydrocodone Bitartrate and Acetaminophen tablets, a pain relieving drug, in the American market.

The company has bagged the approval of US Food and Drug Administration (USFDA) for the product. The company's product is indicated for relief from moderate to moderately severe pain and is a generic equivalent of Mikart Inc's Hydrocodone Bitartrate and Acetaminophen tablets.

According to IMS MAT sales data, Hydrocodone Bitartrate and Acetaminophen tablets had sales of USD 89.6 million (Rs 608 crore) in the US market.

Lupin has the fifth largest pipeline of abbreviated new drug application (ANDA) filings pending approval with the USFDA. The company cumulative filings with the USFDA stand at 339, with the company having received approvals for 198 products. 

On the financial front, Lupin’s revenue increased 28.9 per cent to Rs 4291 crore in Q2FY17 on a yearly basis. The company’s EBITDA jumped 55.2 per cent to Rs 1028 crore in Q2FY17, as compared to the same period in the previous financial year. Its net profit also soared 56.2 per cent to Rs 659 crore in Q2FY17 on a yearly basis.

The share price of Lupin increased 2.14 per cent on the bourses in early trades and closed at Rs 1412.75 on intraday basis.