Alkem Laboratories Receives EU GMP Certificate for Daman Manufacturing Facility
Alkem Laboratories has received a Certificate of GMP Compliance from the Malta Medicines Authority for its Daman manufacturing facility, following a successful inspection conducted on December 9, 2025. The certification validates the facility's adherence to European Union Good Manufacturing Practice standards and remains valid for 3 years from the inspection date.
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Alkem laboratories has announced the receipt of a Certificate of GMP Compliance from the Malta Medicines Authority for its manufacturing facility located at Daman, India. The pharmaceutical company informed stock exchanges about this regulatory milestone on March 20, 2026, pursuant to Regulation 30 of the SEBI LODR Regulations.
Certificate Details and Validity
The Certificate of GMP Compliance has been issued by the Malta Medicines Authority with respect to the company's Daman manufacturing facility. The certification carries significant operational value as it validates the facility's adherence to European Union Good Manufacturing Practice standards and is valid for 3 years starting December 9, 2025.
| Parameter: | Details |
|---|---|
| Issuing Authority: | Malta Medicines Authority |
| Facility Location: | Daman, India |
| Certificate Type: | Certificate of GMP Compliance of a Manufacturer |
| Validity Period: | 3 years |
| Validity Start Date: | December 9, 2025 |
| Inspection Date: | December 9, 2025 |
Regulatory Timeline
The certification follows a structured regulatory process that began with the GMP inspection conducted on December 9, 2025. Alkem Laboratories had previously informed the exchanges about the Malta Medicines Authority's inspection at its Daman facility through an intimation dated December 10, 2025. The successful completion of this inspection has now resulted in the formal certification.
Compliance and Disclosure
The company has fulfilled its disclosure obligations under the SEBI LODR Regulations by informing both BSE Limited and National Stock Exchange of India Limited about this development. As per regulatory requirements, a copy of this disclosure will be made available on the company's website in accordance with Regulation 30(8) of the SEBI LODR Regulations.
The announcement was signed by Manish Narang, President – Legal, Company Secretary & Compliance Officer, ensuring proper corporate governance protocols were followed in the disclosure process.
Historical Stock Returns for Alkem Laboratories
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +2.96% | -0.49% | -3.52% | -4.46% | +4.84% | +103.93% |
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