Mumbai: Bajaj Healthcare Ltd. has received the Central Drugs Standard Control Organisation (CDSCO)’s Subject Expert Committee’s (SEC) nod to conduct the Phase III clinical trials for its Suvorexant tablets, a prescription drug used to treat insomnia. This move marks a significant step in the company’s formulation pipeline, indicating its intent to enter high growth therapeutic segments currently dominated by global heavyweights.
During the Phase III trials, the drug will be evaluated for its safety, efficacy and tolerability in a diverse set of patients-the final step before the company can submit the drug to the regulator for commercial use.
“We are encouraged by the SEC’s recommendation and remain committed to advancing Suvorexant through the final stages of clinical development. With our robust R&D infrastructure and GMP-compliant manufacturing capabilities, we are confident in our ability to deliver high-quality, impactful CNS solutions to patients worldwide. This development not only strengthens our neurology portfolio but also aligns with our strategic vision of addressing unmet medical needs in chronic and lifestyle-related disorders.” Mr. Anil Jain, Managing Director, Bajaj Healthcare Limited, said in a press release.
Bajaj Healthcare has seen its shares rise 30% on the back of a consistent increase in revenue and net profit. The company has seen a net profit growth of 18% CAGR in the past 10 years, especially since it is one of the few homegrown API manufacturers in India. Besides this, the small cap company is actively expanding its presence through its acquisition of GenRx Pharmaceuticals, which was announced in April this year.
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