Alkem Laboratories has successfully obtained a ‘Certificate of GMP Compliance of a Manufacturer’ from the Malta Medicines Authority for its key manufacturing facility located in Daman, India. This essential certification confirms adherence to EU Good Manufacturing Practices. The certificate is valid for a substantial period of three (3) years, commencing from the date of inspection, which occurred on December 9, 2025. This ongoing approval is vital for Alkem’s continued access to European markets.
Confirmation of EU GMP Compliance
Alkem Laboratories Ltd. has formally announced the receipt of significant regulatory clearance for its production site in Daman, India. Following an inspection conducted by the Malta Medicines Authority, the Company has been granted a ‘Certificate of GMP Compliance of a Manufacturer’.
Validity and Market Access
This certification is crucial as it affirms that the Daman facility meets stringent European Union Good Manufacturing Practices (GMP) standards. The certificate confirms compliance for a period of three (3) years. The effective start date of this validity period is anchored to the date of the inspection, which was recorded as December 9, 2025.
Official Disclosure
This update follows a previous intimation made by the Company on December 10, 2025, regarding the initiation of the GMP inspection process. The disclosure was finalized and signed on March 20, 2026, by Manish Narang, President – Legal, Company Secretary & Compliance Officer, confirming Alkem’s ongoing commitment to global quality standards.
Source: BSE
