Aurobindo Pharma gains on USFDA approval for Tramadol Hydrochloride

The stock was up 2% at Rs 827 after the company has got final approval from the USFDA to manufacture and market Tramadol Hydrochloride Extended release tablets.

Aurobindo Pharma is trading higher by 2% at Rs 827 on the BSE after the company announced that it 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.

This product will be launched by Q4 FY 2015-16.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) ULTRAM® ER (Tramadol Hydrochloride) Extended-Release Tablets 100 mg, 200 mg and 300 mg of Valeant INTL, Aurobindo Pharma said in a press release.

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 US$56 million for the twelve months ending August 2015.

This is the 50th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products.

The stock hit an intra-day high of Rs 829 on the BSE. A combined 817,547 shares changed hands on the counter on the BSE and NSE till 12:09 am.