Alkem Gets EU GMP Compliance Certificate for Daman Facility from Malta Authority
New Delhi: Alkem Laboratories Limited has received a Certificate of GMP Compliance of a Manufacturer from the Malta Medicines Authority for its manufacturing facility located in Dama, India, the company informed through a regulatory filing.
The certification has been granted following an inspection conducted on December 9, 2025, and will remain valid for a period of three years from the date of inspection. The development comes in continuation of the company’s earlier intimation dated December 10, 2025, regarding the GMP inspection carried out by the Malta Medicines Authority at the same facility.
The company stated that the receipt of the GMP compliance certificate signifies adherence of its Daman manufacturing unit to European Union Good Manufacturing Practice (EU GMP) standards, which are essential for ensuring quality, safety, and efficacy in pharmaceutical production.
The intimation was made under Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015, as amended. As per the filing, the disclosure will also be made available on the company’s official website in compliance with Regulation 30(8) of the SEBI LODR Regulations.
The company has formally communicated the update to both stock exchanges, including BSE Limited (Scrip Code: 539523) and the National Stock Exchange of India Limited (Scrip Symbol: ALKEM), requesting them to take the information on record.
The communication was signed by Manish Narang, President – Legal, Company Secretary and Compliance Officer of Alkem Laboratories Limited.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.