Supriya Lifescience Ltd. has received regulatory approval from Brazil’s health authority, ANVISA (Agência Nacional de Vigilância Sanitária), for Esketamine Hydrochloride. This approval will enable the company to broaden its product range in Brazil and the wider LATAM region.
As reported by medicaldialogues, the company has achieved two significant milestones, further strengthening its position in international markets. According to the company, it is the first in Brazil to receive regulatory permission for this highly specialized pharmaceutical.
Esketamine Hydrochloride is a vital drug used in the treatment of mental illnesses.
“This approval will enable the company to provide state-of-the-art, high-quality healthcare solutions in a market where demand for novel, reasonably priced drugs is growing. Moreover, the business submitted a groundbreaking patent application for an enhanced, low-cost method of atorvastatin synthesis. This ground-breaking technique makes drugs more affordable for patients by increasing their efficacy while reducing production costs. Global healthcare relies heavily on atorvastatin, a key treatment for controlling cholesterol and preventing cardiovascular disease, and this achievement shows Supriya’s dedication to drug cost and raising accessibility,” the company stated in a release.
Supriya Lifescience Ltd., a producer of active pharmaceutical ingredients (APIs), was founded in 1987. The company operates a cutting-edge facility certified by Health Canada, EUGMP, EDQM, USFDA, and NMPA. Headquartered in Mumbai, India, with its facility located in Khed, District Ratnagiri, Supriya Lifescience’s globally compliant operations include certifications from EMA, US FDA, WHO, PMDA, TGA, KFDA, and ANVISA.
The company’s robust R&D capabilities include eight active CEPs and fourteen active USDMFs. Committed to ethical principles and EHS standards, Supriya Lifescience focuses on developing intermediates and APIs for both innovators and generic manufacturers. It also collaborates exclusively with partners as a CMO, underscoring its dedication to providing innovative and affordable healthcare solutions.