Alkem Laboratories has recently informed exchanges that the Malta Medicines Authority conducted a Good Manufacturing Practices (GMP) inspection at the company’s Daman manufacturing facility from 5 December to 9 December 2025. The inspection concluded on 9 December with a favourable outcome for the company.
As per Alkem, the regulatory team reported no critical observations. The facility received three major observations and a few minor observations, all of which the company is preparing to address within the mandated timelines. Alkem noted that it remains committed to implementing the required corrective and preventive actions to ensure full compliance with global quality and regulatory standards.
The company added that the positive closure of the inspection, particularly in the absence of any critical findings, underscores its ongoing focus on operational excellence and quality assurance across its manufacturing network.
