FDA approval for animal health products

31 August, 2007

FDA approval for animal health products opens export doors

An Auckland company has cracked rigorous United States Food and Drug Administration (FDA) requirements positioning it to become a global supplier of animal health products from New Zealand.

The stamp of approval means Argenta Limited has the only FDA-approved facility in New Zealand for the commercial manufacture and supply of such a range of chemistry-based animal health products and has already helped the company clinch a multi million dollar manufacturing contract, with more new work in the pipeline.

“The approval gives us significant credibility in international markets. We know our expertise and facility are world class and now have credentials to prove it. It also gives us access to the US, which represents between 30 and 40 per cent of the global market for animal health products,” says Doug Cleverly, CEO of Argenta.

The first US-bound products from Argenta are treatments for sheep and cattle, which the company is contract manufacturing for a US animal health company. However Dr Cleverly says the greatest potential lies in supplying the companion animal market with pharmaceuticals for cats, dogs and other home pets. Approximately 40 per cent of all animal health spending is on companion animal products.

Argenta was formed a year ago through the acquisition of Nufarm Health and Sciences, which manufactured animal health pharmaceuticals for the Australasian market, and Chemlabs, an animal health research and development company. The company has increased its export activity over the last 12 months and says with FDA accreditation under its belt, it is now placed to become a true global supplier.

FDA assessors spent a week at Argenta’s premises in May and the company achieved another milestone by passing the inspection first time.

“At the end of the week the FDA staff had no findings and went back to the FDA and recommended the site be approved. It’s quite rare to achieve that straight off,” says Dr Cleverly.

He credits the result to an extremely intensive and expensive work programme carried out by Argenta over the previous nine months and led by an FDA consultant from the US, whose involvement was supported by investment from the Foundation for Research, Science and Technology.

The Foundation contributed NZ$130,000 through its Technology Expert scheme to the costs of bringing Assumpta Norrell to New Zealand for regular visits to ensure Argenta would meet the FDA’s rigorous technical and operational standards.

“Assumpta’s assessment after we had acquired the business showed we were in very poor shape and there were literally hundreds of things we had to do, ranging from buying new equipment to having the right systems in place. It was a huge task and a huge boost to everyone when we succeeded.”

He says support from the Foundation was crucial in the process.

“Buying Nufarm’s animal health business and Chemlabs a year ago was a major financial commitment and the Foundation investment allowed us to engage Assumpta as the lead on this project but also to dedicate other resource to the FDA programme. The result was that we were far better prepared for the FDA when they came.”

Dr Cleverly says the process has had positive spin offs in addition to receiving FDA approval.

“The work showed us that many of our internal processes were so complex they were actually hamstringing operations. There were so many rules and protocols people didn’t know which ones to follow.

“As well as simplifying our systems the exercise has brought about a culture change among staff, who are more motivated and energised. We are poised for growth and aim to be internationally competitive which brings a greater sense of urgency and greater demands. But it also brings more pride. There was a lot of nervousness about the FDA audit and it’s been a real boost to have been through the process with such success.”

Research and development is a key area of focus for Argenta and Dr Cleverly says the FDA approval opens the door to it developing new products in-house for global pharmaceutical companies.

“While products for the health of production animals like sheep and cattle is core business there is a tyranny of distance in exporting the volumes required by commercial farmers. The freight costs are small, by comparison, for pharmaceuticals for companion animals and there is a very high value market to access. Pet owners are prepared to spend what it takes to get the right drug to make their animal better.”

Argenta has a staff of 90 at its GMP (Good Manufacturing Practice) and Good Laboratory Practise (GLP) accredited premises in Manurewa, up from 72 when the company was formed a year ago.

Note to Editors

The Foundation for Research, Science and Technology invests over $460 million a year on behalf of the New Zealand Government, in research, science and technology. These investments are made to enhance the wealth and well being of New Zealanders.

The Technology Expert Scheme is designed to assist companies undertake commercially focused research or technology development projects. Experts work alongside staff, transferring their knowledge and skills to build new technical and technology commercialisation capabilities within the company.

The Foundation meets the actual costs of the salary component for approved experts.

ENDS

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