A vaginal ovule production unit approved by the FDA, EMA and Health Canada

The project

Intrarosa comes in the form of a vaginal ovule. It treats symptoms caused by the hormonal changes of menopause and improves the quality of life of many women. Approved in the United States in 2016, in Europe in 2018 and in Canada in 2019, it is now marketed in North America, Europe, the Middle East and Oceania.

The Mont‑Saint‑Hilaire plant now has the largest production capacity for suppositories and vaginal ovules in North America.

The challenges

• Keeping the preparation within a very narrow temperature range so that it stays liquid, despite its viscosity, throughout its transfer
• Handling a highly potent hormonal active ingredient (OEL 3): protecting both the operators and the quality of the product
• Building inside an operating plant that makes other dosage forms: access for skids and bulky equipment, integration of the new equipment, optimal use of existing systems
• Passing FDA, EMA and Health Canada inspections
• Delivering fast: all the engineering done in design-build mode, within a few weeks, to bring the product to market sooner

Two innovations

• Full containment of the flows (materials and utilities) in service chases built from cleanroom panels: less cross-contamination, no product buildup in the lines, and protected staff
• A feed system for the fat granules that increases their contact time with the heated surfaces: solution preparation time is cut by a factor of 4 to 6, with a dramatic drop in capital and operating costs

A responsible project

A detergent chosen to meet both environmental discharge criteria and validated cleaning performance, grease traps that capture fats and oils from the effluents at the source, and wastewater treatment and recycling: the site meets the requirements of the Ministry of the Environment and the municipality.

The results

A project delivered on budget, on schedule and to the expected performance, successful FDA, EMA and Health Canada inspections, and marketing authorizations in more than ten countries: Endoceutics is bringing this medicine to as many women as possible.