Brand-Nu Launches Chlophedianol Hydrochloride for Pharmaceutical Industry

Brand-Nu Laboratories, a leading US-based high purity chemical manufacturer and distributor, has introduced Chlophedianol Hydrochloride, also known as Clofedanol Hydrochloride JP, to its product portfolio of active pharmaceutical ingredients (APIs).

Chlophedianol Hydrochloride has been recognized as a possible replacement for Dextromethorphan in cough and cold formulations. 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.” The FDA’s Drug Safety and Risk Management Advisory Committee is holding a meeting on Sept. 14th to discuss the abuse potential of Dextromethorphan and the health benefits and risks associated with its use as a cough suppressant. This process is reminiscent of that which resulted in regulations being imposed on pseudoephedrine-containing cold formulations in the mid 2000’s.

“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,” said Mary Ann Poole, Vice President and General Manager at Brand-Nu Laboratories.

Brand-Nu Laboratories’ Chlophedianol Hydrochloride is manufactured under cGMP and meets JP specifications.