Sonoma Pharmaceuticals Inc, a global healthcare leader specialising in stabilised hypochlorous acid (HOCl) products for diverse applications such as wound care, dermatology, eye and oral care, podiatry, animal health, and non-toxic disinfectants, has announced the successful registration of its manufacturing facility and listing of its Microcyn-based facial spray under the US FDA’s Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
This new registration broadens Sonoma’s regulatory foundation, authorising the company to manufacture and market its Microcyn technology-based products as cosmetics in the United States. The facility was already US FDA-registered as a medical device establishment, supporting a portfolio of 510(k)-cleared products across multiple therapeutic categories. The addition of MoCRA registration now allows Sonoma to expand into the fast-growing US cosmetics and dermatology markets.
Industry projections suggest the US skincare market will approach USD 40 billion by 2030. Sonoma’s patented hypochlorous acid technology, known for its safety and proven efficacy in treating common skin conditions, positions the company strongly to meet growing consumer demand for clean and science-backed skincare solutions.
“Sonoma’s regulatory strength enables us to deliver safe, effective products across healthcare segments,” said Amy Trombly, CEO of Sonoma. “The MoCRA registration enhances our ability to expand in the US cosmetics and dermatology sectors, driving further growth and value creation.”
Headquartered in Boulder, Colorado, Sonoma operates manufacturing facilities in Guadalajara, Mexico, and oversees European marketing from Roermond, Netherlands. The company’s products are available in over 55 countries worldwide through direct and partner-led distribution.