Rubicon Research receives US FDA approval for its ANDA for Amantadine Capsules USP, 100 mg
Thane, Mumbai (India), May 26, 2020
Rubicon Research Pvt Ltd has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amantadine Capsules USP in the strength of 100 mg.
Amantadine Hydrochloride Capsules, USP, are indicated for prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Capsules, USP, are also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions. According to IQVIA MAT data, the US market for Amantadine Capsules USP, 100 mg, is approximately US$ 27 Mn.
Amantadine Hydrochloride, USP, 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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