Recipharm, a leading contract development and manufacturing organisation (CDMO), is pleased to note the FDA’s approval of Perrigo’s AB-rated generic of ProAir HFA (albuterol).
Bespak Europe Limited which was recently acquired by Recipharm, developed and will be manufacturing the dose counter and metered-dose inhaler valve that Catalent Pharma Solutions uses to manufacture the finished drug product.
The FDA’s approval marks a significant achievement for all companies involved in the product’s development due to the various difficulties commonly associated with the production of complex generics. Perrigo’s product is the first generic metered-dose inhaler to be approved by the FDA in over twenty years.
The generic albuterol sulphate inhalation aerosol, is designed to treat and prevent bronchospasm with reversible obstructive airway disease.
Commenting on the FDA approval, Jean-François Hilaire at Recipharm said: “There is growing demand for inhalable products to treat patients with respiratory diseases and this is an ongoing core focus in our business. Having a role in this industry-leading collaboration is an exciting opportunity for Recipharm and as Bespak integrates into our business, we look forward to working closely with Perrigo and Catalent to ensure the commercial success of this important new product.”
Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) in the pharmaceutical industry employing almost 9,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, and pharmaceutical product development. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. Recipharm’s turnover is approximately SEK 7.5 billion. The company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Stockholm, Sweden. The Recipharm B-share (RECI B) is listed on Stockholm.