Alkem Laboratories announced the successful receipt of a ‘Certificate of GMP Compliance of a Manufacturer’ for its manufacturing facility located in Baddi, India. The certification was issued by the Department of Pharmacy – Germany, following an inspection conducted between November 4, 2025, and November 10, 2025. This crucial certificate validates the site’s compliance with European Union Good Manufacturing Practices and is valid for a period of three years.
Regulatory Compliance Milestone Achieved
Alkem Laboratories has successfully secured vital regulatory approval for its production site situated in Baddi, India. The company confirmed the receipt of a ‘Certificate of GMP Compliance of a Manufacturer’, a prerequisite for supplying pharmaceutical products to the European Union market.
German Authority Inspection Details
The certification stems from a comprehensive inspection carried out by the Department of Pharmacy (Human Medicines) – Germany. The inspection process spanned seven days, beginning on November 4, 2025, and concluding on November 10, 2025. This confirmation ensures that the Baddi facility adheres to stringent European Union Good Manufacturing Practices (GMP).
Certificate Validity Period
A key highlight of this announcement is the duration of the renewed compliance. The new GMP Certificate is valid for an extensive period of 3 (three) years, commencing from the date of the inspection. This long-term validation provides significant stability for Alkem’s European export strategy originating from the Baddi unit.
Corporate Confirmation
The intimation was formally issued by Manish Narang, President – Legal, Company Secretary & Compliance Officer, on March 14, 2026, confirming the fulfillment of necessary disclosure requirements.
Source: BSE
