Aurobindo Pharma, a mid-size pharmaceutical company, announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Tramadol Hydrochloride extended-release tablets USP, 100 mg, 200 mg and 300 mg.
Tramadol Hydrochloride extended-release tablets are used in the treatment of moderate-to-severe pain in adults who require around-the-clock treatment for an extended period of time.
According to IMS, the approved product has an estimated market size of USD 56 million for the twelve months ending August 2015.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product ULTRAM ER extended-release tablets 100 mg, 200 mg and 300 mg of Valeant INTL.
Shares of the company gained Rs 12.05, or 1.48%, to trade at Rs 825.00. The total volume of shares traded was 44,163 at the BSE (10.47 a.m., Friday).