Lasalle, Quebec , November 24, 2025, Minakem Montreal is pleased to announce the successful completion of a U.S. Food and Drug Administration (FDA) surveillance inspection at our facility located at 9321 Airlie Street, H8R 2B2, Lasalle, Quebec.
The inspection took place from September 15 to September 18, 2025.
The FDA review focused on compliance with current Good Manufacturing Practices for active pharmaceutical ingredients and assessed key systems, including:
- Quality System: Document control, deviation management, change control, and complaint handling.
- Production System: Manufacturing operations, batch record review, and process validation.
- Facilities & Equipment: Design, maintenance, cleaning validation, and equipment qualification.
- Materials System: Raw material controls, supplier qualification, and storage practices.
- Laboratory Controls: Analytical testing, data integrity, and stability programs.
We are proud to report that the inspection was classified as “No Action Indicated”, meaning the facility is considered by the FDA to be in full compliance with cGMP requirements.
This outstanding result reflects our unwavering commitment to quality, safety, and regulatory excellence. We thank our dedicated teams for their professionalism and continuous efforts to uphold the highest standards in pharmaceutical manufacturing.
About Minakem Montréal
Minakem Montréal, our North American site, offers large-scale manufacturing capabilities for custom synthesis and small-molecule APIs, including controlled substances, using versatile technologies.
Since acquiring Delmar Chemicals Inc. in 2023, we have expanded our capacity to produce more than 20 APIs from Canada. Our integrated R&D center enables the successful development and production of commercial APIs or intermediates for complex, multi-step synthesis.
In addition to manufacturing excellence, our team provides regulatory filing support for major markets, including the United States, European Union, Japan, and China, ensuring compliance and smooth market access for our partners.
About Minafin Group’s Health Chemistry Division : Minakem
The Health Chemistry division is a European leader in developing synthesis processes and manufacturing active ingredients for the pharmaceutical industry. Through its Minakem CDMO and Minakem Generics & New Therapies business units, the division offers a comprehensive range of cutting-edge technologies and pharmaceutical services. The company is dedicated to providing customers with a continuous supply of high-quality products and leverages its expertise to develop exclusive manufacturing processes and ensure cGMP-compliant production of pharmaceutical actives. With patient needs at the forefront, the Health Chemistry division prioritizes the strictest health and environmental safety standards for all its manufactured products.
www.minakem.com
Press Contact
Véronique Lutun – Communications Manager
veronique.lutun@minakem.com
Minakem Montréal
9321 Rue Airlie, Lasalle, QC H8R 2B
Tel : +1 514 366 7950