Aurobindo Pharma today said it may launch Tramadol Hydrochloride extended-release tablets, used for treating pain, in the US market from January.
According to a statement issue by the company, it received final approval from the US Food and Drug Administration (USFDA) to manufacture and market the drug.
The approved ANDA is bio-equivalent and therapeutically equivalent to the reference listed drug product Ultram ER (Tramadol Hydrochloride) extended-release tablets 100 mg, 200 mg and 300 mg of Valeant Intl, it said.
These 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.
The drug has an estimated market size of USD 56 million for the 12 months ended August 2015, according to IMS.
This is the 50th ANDA to be approved out of unit VII formulation facility in Hyderabad, for manufacturing oral non-antibiotic products.
Aurobindo now has a total of 217 ANDA approvals (189 final approvals including 10 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA, it added.
Shares of Aurobindo were trading at Rs 825.90 apiece, up 1.59 per cent on BSE.