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news.Brand-Nu Laboratories has added Chlophedianol Hydrochloride, a possible replacement for Dextromethorphan in cough and cold formulations, to its product portfolio of active pharmaceutical ingredients (APIs). It is also known as Clofedanol Hydrochloride JP.
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Brand-Nu Laboratories, a US-based high purity chemical manufacturer and distributor, said that its Chlophedianol Hydrochloride is manufactured under cGMP and meets JP specifications.
Dextromethorphan has been under review by the FDA based on a request from the DEA for an evaluation.
According to the FDA website: “The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for dextromethorphan in response to the increased incidence of abuse, especially among adolescents.”
Mary Ann Poole, vice president and general manager at Brand-Nu Laboratories, said: “With the controversy surrounding Dextromethorphan, we wanted to offer drug manufacturers a cost-effective and reliable option for the supply of Chlophedianol Hydrochloride.
“It demonstrates our commitment to providing unique solutions to the pharmaceutical industry and is an exciting addition to our growing API line.”