Unichem Laboratories has received ANDA approval from the United States Food and Administration (USFDA) for Tizanidine Tablets. Tizanidine tablets USP 2mg and 4mg are therapeutically equivalent to ZANAFlEX tablets 2mg and 4mg from Acorda Therapeutics. Tizanidine tablets belong to a group of medicines called skeletal muscle relaxants. Tizanidine tablets is used to help relieve, although not cure, muscle spasms caused by medical conditions such as multiple sclerosis or injuries to the brain or spine.
Further, the product will be commercialized from Unichem’s Goa plant. Further, active pharmaceutical ingredient i.e., Tizanidine Hydrochloride used for this ANDA is also made in-house at Roha plant.
Currently, there are 9 generic approvals, while only 3 companies are dominating the market. The current market size is $70 million growing at 5% in value terms and 10% in volume.
