The Malta Medicines Authority conducted a GMP inspection of Alkem Laboratories’ manufacturing facility in Daman, India, from December 5th to December 9th, 2025. The inspection concluded with no critical observations, three major observations, and a few minor observations. The company will address these observations within the stipulated timeframe.
GMP Inspection Update
Alkem Laboratories has announced the completion of a Good Manufacturing Practice (GMP) inspection by the Malta Medicines Authority at its manufacturing facility located in Daman, India. The inspection took place between December 5th, 2025 and December 9th, 2025.
Inspection Findings
The inspection concluded on December 9th, 2025. According to the official announcement, the Malta Medicines Authority reported no critical observations. However, there were three major observations and a few minor observations noted during the inspection.
Next Steps for Alkem
Alkem Laboratories is committed to addressing all observations identified during the GMP inspection. The company stated it will address the major and minor observations within the stipulated timeframe to ensure continued compliance with GMP standards.
Source: BSE