Sun Pharmaceutical Industries’ arm gets USFDA nod for generic Ultram ER Tablets

10 Dec 2011 Evaluate

Sun Pharmaceutical Industries’ subsidiary has been granted an approval from United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) to market a generic version of Ultram ER, Tramadol hydrochloride extended release tablets.

These generic Tramadol hydrochloride extended release tablets, 100 mg, 200 mg and 300 mg are therapeutically equivalent to Ultram ER tablets of Valeant. These Tramadol HCL ER tablets have annual sales of approximately $125 million in US.

Tramadol HCL ER tablets are indicated for management of moderate to moderately severe chronic pain in adults who need around-the-clock treatment of their pain for an extended period of time.

Sun Pharmaceutical Industries manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.

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