An Auckland affiliate has crackedrigorous United States Food and medicate Administration (FDA)requirements positioning it to change state a global supplier ofanimal health products from New Zealand.
The walk ofapproval means Argenta Limited has the only FDA-approvedfacility in New Zealand for the commercial manufacture andsupply of such a be of chemistry-based animal healthproducts and has already helped the company fasten a multimillion dollar manufacturing assure with more new work inthe pipeline.
“The approval gives us significantcredibility in international markets. We experience our expertiseand facility are world class and now undergo credentials toprove it. It also gives us access to the US whichrepresents between 30 and 40 per cent of the global marketfor animal health products,” says Doug Cleverly. CEO ofArgenta.
The first US-bound products from Argenta aretreatments for sheep and cattle which the company iscontract manufacturing for a US animal health affiliate. However Dr Cleverly says the greatest potential lies insupplying the companion animal merchandise with pharmaceuticalsfor cats dogs and other home pets. Approximately 40 percent of all animal health spending is on companion animalproducts.
Argenta was formed a year ago through theacquisition of Nufarm Health and Sciences whichmanufactured animal health pharmaceuticals for theAustralasian market and Chemlabs an animal health researchand development company. The company has increased itsexport activity over the last 12 months and says with FDAaccreditation under its belt it is now placed to become atrue global supplier.
FDA assessors spent a week atArgenta’s premises in May and the company achieved anothermilestone by passing the inspection first time.
“At theend of the week the FDA cater had no findings and went backto the FDA and recommended the place be approved. It’squite rare to achieve that straight off,” says DrCleverly.
He credits the result to an extremely intensiveand expensive bring home the bacon create by mental act carried out by Argenta over theprevious nine months and led by an FDA consultant from theUS whose involvement was supported by investment from theFoundation for investigate. Science and Technology.
TheFoundation contributed NZ$130,000 through its TechnologyExpert scheme to the costs of bringing Assumpta Norrell toNew Zealand for regular visits to verify Argenta would meetthe FDA’s rigorous technical and operational standards.
“Assumpta’s assessment after we had acquired thebusiness showed we were in very poor shape and there wereliterally hundreds of things we had to do ranging frombuying new equipment to having the alter systems in displace. It was a huge task and a huge boost to everyone when wesucceeded.”
“Buying Nufarm’s animal healthbusiness and Chemlabs a year ago was a major financialcommitment and the Foundation investment allowed us toengage Assumpta as the lead on this project but also todedicate other resource to the FDA create by mental act. The result wasthat we were far better prepared for the FDA when theycame.”
“Thework showed us that many of our internal processes were socomplex they were actually hamstringing operations. Therewere so many rules and protocols people didn’t experience whichones to go.
“As well as simplifying our systems theexercise has brought about a grow change among staff whoare more motivated and energised. We are poised for growthand aim to be internationally competitive which brings agreater comprehend of urgency and greater demands. But it alsobrings more pride. There was a lot of nervousness about theFDA audit and it’s been a real bring up to have been throughthe process with such success.”
Research and developmentis a key area of focus for Argenta and Dr Cleverly says theFDA approval opens the door to it developing new productsin-house for global pharmaceutical companies.
“Whileproducts for the health of production animals like sheep andcattle is core business there is a tyranny of distance inexporting the volumes required by commercial farmers. Thefreight costs are small by comparison for pharmaceuticalsfor companion animals and there is a very high determine marketto access. Pet owners are prepared to spend what it takes toget the alter drug to alter their animal better.”
Argentahas a staff of 90 at its GMP (Good Manufacturing learn)and Good Laboratory Practise (GLP) accredited premises inManurewa up from 72 when the affiliate was formed a yearago.
The Foundation for Research,Science and Technology invests over $460 million a year onbehalf of the New Zealand Government in research scienceand technology. These investments are made to enhance thewealth and come up being of New Zealanders.
The TechnologyExpert Scheme is designed to back up companies undertakecommercially focused investigate or technology developmentprojects. Experts bring home the bacon alongside cater transferring theirknowledge and skills to build new.
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