Shares of Aurobindo Pharma soared nearly 6% in the afternoon session on February 8 after the drugmaker said its downline subsidiary Aurolife Pharma had been granted USFDA clearance to manufacture and market diclofenac sodium topical solution USP.

The stock was one of the top gainers among midcaps, trading at Rs 443.40, up Rs 24.75, or 5.91% on the BSE.

It touched an intraday high of Rs 443.60 and an intraday low of Rs 415.35. The stock’s volume was 157,834 shares, compared with its five-day average of 56,684 shares, an increase of 178.44%.

Aurobindo Pharma said in an exchange document that Diclofenac Sodium Topical Solution USP is indicated for treating knee osteoarthritis pain. It is bioequivalent and therapeutically equivalent to Horizon Therapeutics Ireland DAC (Horizon)’s Reference Listed Drug (RLD), Pennsaid Topical Solution, 2% weight by weight (w/w). The product is expected to launch in the first quarter of FY24.

According to IQVIA, the market size for the approved products is estimated to be approximately $487 million for the twelve months ending December 2022.

This is the first Abbreviated New Drug Application (ANDA) approved by the Aurolife Unit-II in North Carolina, USA, to manufacture a topical product. The company added that Aurobindo now has 430 ANDA approvals (404 final and 26 tentative) from the USFDA.

Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad. The company develops, manufactures and commercializes a broad range of generic pharmaceuticals, branded speciality pharmaceuticals and active pharmaceutical ingredients in more than 150 countries worldwide.