Galway pharma firm shipping animal products to lucrative US market

Chanelle spent two years securing approval from Food and Drug Administration

Company owner Michael Burke says the FDA approval is ‘a game changer’ for Chanelle.
Company owner Michael Burke says the FDA approval is ‘a game changer’ for Chanelle.

Galway-based generics giant Chanelle has started shipping animal health products to the United States. It is the culmination of a five-year process for company owner Michael Burke, who first announced plans to invest €10 million in a facility dedicated to supplying the US market from Loughrea in early 2016.

The company has spent two years securing US marketing approval from the Food and Drug Administration (FDA), which regulates the industry there. The 30,000sq ft Galway facility produced Spot On, a treatment used globally to protect dogs and cats against harmful parasites.

“The achievement of FDA approval for our Spot On facility is a game changer for our company,” Mr Burke said. “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”.

Entry into the US will enable Chanelle Pharma to grow its share of the global market in anti-parasitic health products, Mr Burke says. The global market for flea, tick and heartworm products was estimated at $3.3 billion in 2018, with North America accounting for about $1.3 billion of that.

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Survey

Chanelle cites a survey earlier this year by the American Pet Products Association showing that just over two-thirds of US households own a pet, up from 56 per cent in 1988, which works out at 84.9 million homes.

The survey found that millennials – those currently aged between about 25 and 40 – are the most likely to own pets and are willing to pay more for quality products and services to improve the health and well-being of their pets.

Mr Burke said the company was now moving ahead with plans to invest €11 million in a new 25,000sq 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,” he said.

Additional jobs

Privately-owned Chanelle Pharma was founded by Mr Burke, a vet in Loughrea in the 1980s. It is Ireland’s largest manufacturer of generic medicines for human and animal health, with sales of more than €135 million in the year to April 30th 2020. That was up 11 per cent on 2019.

The business, which employs more than 500 people with plans for hundreds of additional jobs over the next four years, is the largest Irish-owned manufacturer of generic pharmaceutical products.

Chanelle exports to 96 countries worldwide. It holds more than 3,500 product licences for animal health medications and about 1,900 product licences for human health products worldwide.

Dominic Coyle

Dominic Coyle

Dominic Coyle is Deputy Business Editor of The Irish Times