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Rubicon Research receives US FDA approval for its ANDA for Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg

Thane, Mumbai (India), May 29, 2020

Rubicon Research Pvt Ltd has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tizanidine Hydrochloride Capsules, 2 mg (base), 4 mg (base), and 6 mg (base).

Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief from spasticity is most important.

According to IQVIA MAT data, the US market for Tizanidine Capsules USP 2 mg, 4 mg, and 6 mg is approximately US$ 26 Mn.

Tizanidine Hydrochloride Capsules, 2 mg (base), 4 mg (base), and 6 mg (base) is the latest product emerging from Rubicon Research’s fast-growing portfolio.

About Rubicon Research Pvt Ltd

Rubicon Research is an IP led, specialty pharmaceutical company that develops, manufactures and commercializes its value-added formulations for the global market. The company leverages its proprietary technologies and specialized formulation development skills to provide solutions to complex delivery challenges; enabling better patient outcomes.

The company holds more than 50 issued patents in drug delivery technologies and its portfolio spans multiple dosage forms, including oral solids, oral liquids, nasal, ophthalmic, injectable, sterile, topical, drug device combinations and fixed-dose combinations. The flagship manufacturing facility at Ambernath is audited by leading global health authorities.

Rubicon Research operates out of four locations—the corporate HQ and R&D center in Thane, India, the R&D center in Concord, Canada, the manufacturing site in Ambernath, India, and the business development and regulatory office in Plainsboro, US.

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Kermin Bhot
Senior Manager, Corporate Communications