In light of the total ban (effective december 31, 2008) on the production and sale of CFC (chlorofluorocarbon) inhalers that contain albuterol1 in the US, Valois Pharma has leveraged its in-depth expertise as the world’s leading manufacturer of metering valves that use HFA propellant, the pharmaceutical industry’s choice to replace cfc.
A complex issue for the pMDI industry, production of CFCs, which deplete the ozone layer, was banned by the developed nations in 1996, in accordance with the 1987 Montreal Protocol.
However an "essential use" exemption was granted to the pharmaceutical industry, notably for pMDI manufacture, to allow replacement products using HFA to be brought to market.
As there are differences in physicochemical properties between the two propellants, moving to HFA meant that both the drug formulation and the components of pressurised inhalers, and in particular metering valves and gaskets, had to be completely redesigned.
Valois Pharma was ahead of the game in gaining expertise in HFA formulations from the early 1990s, especially about the way that they interact with metering valve components.
Three strategic priorities were identified that would allow the company to develop this expertise and become world leader in this segment:
- Develop and manufacture elastomer gaskets at a dedicated Valois Pharma facility in Normandy, France (Val de Reuil). Grouping formulation and analytical expertise together at one site allowed Valois Pharma to significantly optimise the manufacture of metering valve gaskets;
- Internally manage analytical tests, control of extractibles and tests for compatibility with HFA formulations;
- Create DMF (Drug Master Files) for submission to the FDA.
This allowed all HFA pressurised inhalers manufactured by Valois Pharma clients to be approved for use in the US.
This strategy enabled Valois Pharma to more than double its worldwide market share in metering valves and today, supplies over 50% of the market.
Looking forward, Valois Pharma fully intends to continue to develop both its technology and expertise on a global scale.
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