Montreal Canada, small molecules APIs and steroids APIs

Our Northern American facility, dedicated to small molecules, with versatile technologies and 180 m3 of modern capabilities (more than 50 m$ invested in 2018-2023).
A specific unit, commissioned in 2020, is able to manufacture steroid API.
The site is located in Montreal, very well connected to the airport and to the seaport, a 1H30 flight from New Jersey and Boston aera.

Key FACTS

  • 1 R&D Center with 10 experts
  • QC support: 22 experts
  • 180 m³ of reaction capacity

KEY API & Excipient PRODUCTS

  • Apixaban
  • Bismuth Valproate
  • Esclicarbazapine Acetate
  • Esmolol Hydrochloride
  • Fluorescein
  • Ketorolac
  • Lapatinib Ditosylate
  • Methazolamide
  • Mirabegron
  • Propinox
  • Pyrazinamide
  • Pentamidine isethionate
  • Rosuvastatin calcium
  • Solifenacin Succinate
  • Sorafenib hemi tosylate
  • Succinylcholine Chloride
  • Tofacitnib Citrate

LIST OF PRODUCTS

Minakem Product List July 2023

Core Capabilities

  • Small molecules APIs with a list of more than 20 APIs
  • Corticosteroids for veterinary APIs
  • cGMP facilities (FDA, EMEA, PMDA, AFMPS) with OEB4 containment
  • Regulatory support (CMCs and 85 DMFs)
  • Multi-step API process development, manufacturing and analytical development
  • Development and synthesis capacities in Quality by Design (QbD) environment
  • Solid engineering capabilities: milling, micronization and Freeze-drying
  • Strong organometallic know-how with cryogenic process capabilities, including hydrogenation.
  • Industrialization from feasibility to commercial scale with a pilot plant

Compliance Approvals

  • Health Canada Veterinary – 2021
  • Health Canada Human – 2020
  • FDA (USA) – 2020
  • PMDA (Japan) – 2019
  • KFDA (Korea) – 2007

DMF filing experience: USA, Europe, Japan

Facility Legacy

Founded in 1941, Minakem Montreal, formerly Delmar Chemicals, was a member of Tarlanda Apotex Enterprises and of the 9TG group until being acquired by the Minafin Group in 2023. Minakem Montreal has built a 60+ years track record of success in supplying pharmaceutical and biotech companies with clinical and commercial scale cGMP APIs manufactured using world-class cost-effective production processes.

History

  • 2021: New Steroid production area, OEB4 containment level, more then 10 ML CAD of investment, validated and authorized by Health Canada Controlled Substances
  • 2013 – 2020: Significant investment and upgrading (reactors, condensors, addition of monofluid heating and cooling system, installation of a KiloLab, new warehouse). In 2020 Health Canada Veterinary production authorization received.
  • 1985 – 1990: Laboratoires Pharmedical purchased Delmar, in 1990 sold 49% of the shares to Tarlanda Apotex Enterprises
  • 1963: Mr. Delmar sold the company to John Labatt and current plant in LaSalle was officially opened
  • 1941: founded in Montreal by Mr. Geza Delmar

GOOGLE MAP

MINAKEM Montreal – Google Maps