Company achieves FDA approval to manufacture Spot On for the US market
15th June 2020: Chanelle Pharma has shipped its first products to the US market following the granting of accreditation by the US Food and Drugs Administration (FDA) for its Spot On manufacturing facility. The onerous quality assessment by the FDA, which saw a team of inspectors from the US visit Loughrea, took nearly two years to complete and Chanelle is one of only two companies in Europe to be approved by the FDA to manufacture Spot On for the US market. Spot On is a topical treatment used globally to protect dogs and cats against harmful parasites.
Michael Burke, managing director, Chanelle Pharma, invested €10 million in the new Spot On facility which was officially opened by Tánaiste Simon Coveney in 2018. The new 30,000 sq. ft. facility is Europe’s first dedicated Spot On manufacturing facility built to European and US quality standards.
Chanelle Pharma has secured a contract with one of the largest distributors of veterinary products in the US to ship over 2 million batches of Spot On over the next few months and has already started supplying the US market with product manufactured in Loughrea. It has also secured a new contract to supply additional veterinary products to the US by the year end.
Chanelle Pharma, which is privately owned by its founder and managing director Michael Burke, is Ireland’s largest manufacturer of generic medicines for human and animal health, achieving sales of over €135 million to 30th April 2020, an 11% increase year-on-year.
Michael Burke said; “The achievement of FDA approval for our Spot On facility is a game changer for our company. The process took longer than we envisaged but we are now one of only two companies in Europe with FDA approval which sets us apart from our competitors and opens up the very lucrative US market to Chanelle Pharma”.
FDA approval and entry into the US market will enable Chanelle Pharma to grow its share of the global market in anti-parasitic health products. The global flea, tick, and heartworm products market size was estimated at USD 3.3 billion in 2018. North America held the largest revenue share in 2018, amounting to around USD 1.3 billion.
The potential of the US market for Chanelle Pharma can be seen in the growth in household pets. A 2020 survey by the American Pet Products Association showed that 67% of U.S. households own a pet, which works out to 84.9 million homes. (In 1988 it was only 56%). Millennials continue to be the largest pet-owning demographic and they are willing to pay more for quality products and services to improve the health and well-being of their pets.
Michael Burke said the company is going ahead with plans to invest €11 million in a new 25,000 sq ft manufacturing facility for liquid and paste medicinal products for the US market. “We had hoped to commence construction of our new manufacturing facility towards the end of 2019 but deferred our plans while we concentrated on ensuring our Spot On Facility met FDA approval. The learnings from that process we will now apply to our new facility and we hope this will enable us to achieve FDA certification more quickly once it is built”.
A leading pharma company with a heritage of innovation for over 35 years, Chanelle Pharma currently exports to 96 countries and supplies 10 of the top 12 human generic multinational companies in the world and 10 of the top 12 animal health multinational companies globally. Chanelle Pharma holds over 1,900 product licences for human health products worldwide and 3,500 product licences for animal health. Key markets include the EU, Australia, New Zealand, Japan, South Africa, the Middle East and the USA.