Micro-Sphere, a Swiss-based contract development and manufacturing organisation (CDMO), has successfully completed the Swissmedic inspection of its expanded facility, allowing for the renewal of its GMP approved status and increased manufacturing capacity.
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Swissmedic is the national authorisation and supervisory authority for drugs and medical products in Switzerland. Its approval of Micro-Sphere’s expanded facility near Lugano, in Ticino, will allow the company to provide larger capacity output. This puts the company in a position to supply pharma grade spray dried powders at 10s of MT per year and manufacture up to 500 million capsules per year.
“Our facility met the expectations related to GMP and quality for spray drying and manufacturing services to support our customers. We are satisfied with the result achieved,” said Liana Meneghin, qualified person (QP) at Micro-Sphere.
“Our company is growing and expanding its operations. We have invested a significant amount of time and resource into gaining Swissmedic approval because a positive audit is a critical component of our expansion process,” added Stefano Console, managing director at Micro-Sphere. “We remain deeply committed to excellence and further growth, and quality is crucial to our success and our customers’ satisfaction.”