All operations are carried out in accordance with cGMP standards and in full compliance with the regulatory requirements of the Swiss (Swissmedic), European (EMA) and United States (US-FDA) health authorities.
Micro-Sphere also has extensive demonstrated expertise in the field of high-potency active pharmaceutical ingredients (HPAIs), particularly with dry powders for inhalation and water-insoluble molecules for nanoemulsion dispersion. However, with its core business being contract manufacturing and development of pharmaceutical products, Micro-Sphere also has development capabilities in cosmetics, nutraceuticals and natural products, as well as medical devices.
Lacto-Sphere® is Micro-Sphere’s proprietary Lactose based on the raw material lactose monohydrate of US origin, thus BSE/TSE free. Lacto-Sphere is developed specifically for respiratory formulations and is produced in two variations: Lacto-Sphere MM3 (average particle size 3 μm) and Lacto-Sphere MM50 (average particle size 50 μm).