Montreal, Canada — January 27, 2026. Minakem today announced it is now officially the holder of Drug Master Files (DMFs) for five additional active pharmaceutical ingredients (APIs): Estradiol, Trenbolone, Fluvastatin, Agomelatine, and Marbofloxacin, with associated rights to commercialize them. Each of these APIs is manufactured at Minakem’s Canadian facility in Montreal, strengthening the company’s offering across both human and animal health segments.
This milestone follows Minakem’s 2023 acquisition of the Montreal site from the 9 Trees Group, a key move that broadened the company’s North American footprint and manufacturing capabilities.
“By consolidating DMFs for these strategic APIs at our Montreal site, Minakem expands its proprietary-owned APIs product portfolio and strengthens its position in the corticosteroids market. It underlines Minakem’s commitment to quality, reliability, and regulatory excellence,” said Olivier Ubrich, CEO Minakem.
“This expansion aligns with our long-term portfolio strategy in human and animal health” adds Rudolph Hidalgo, the Minafin’s Group CEO .
The five APIs now covered by Minakem DMFs
| API name | DMF |
| Estradiol hemihydrate | VDMF (USDMF and CEP forecasted in 2027) |
| Trenbolone acetate | VDMF |
| Fluvastatin | Japan |
| Agomelatine | UK, 24 ASMFs in Europe, Swiss, Hong-Kong |
| Marbofloxacin | VDMF, 23 ASMF in Europe, Israel, Kenya, Swiss, UK |
“Montreal brings decades of API manufacturing know‑how and complements our European network. “Customers benefit from robust regulatory support spanning DMFs and CEPs across major markets.”
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