Aurobindo Pharma's share price surged almost 6 percent in the afternoon session on February 8, after the drugmaker said its step-down subsidiary Aurolife Pharma has received US Food & Drug Administration (USFDA) approval to manufacture and market Diclofenac Sodium Topical Solution USP.
The stock was one of the top midcap gainers and was trading at Rs 443.40, up Rs 24.75, or 5.91 percent on BSE.
It has touched an intraday high of Rs 443.60 and an intraday low of Rs 415.35. The scrip was trading with volumes of 157,834 shares, compared to its five-day average of 56,684 shares, an increase of 178.44 percent.
Diclofenac Sodium Topical Solution USP is indicated for the treatment of the pain of osteoarthritis of the knee(s), Aurobindo Pharma said in an exchange filing. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Pennsaid Topical Solution, 2% weight in weight (w/w) of Horizon Therapeutics Ireland DAC (Horizon). The product is expected to be launched in Q1FY24.
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The approved product has an estimated market size of around $487 million for the twelve months ending December 2022, according to IQVIA.
This is the first Abbreviated New Drug Application (ANDA) to be approved out of the Aurolife Unit-II, North Carolina, USA, used for manufacturing topical products. Aurobindo now has a total of 430 ANDA approvals (404 Final approvals and 26 tentative approvals) from USFDA, the company added.
Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.