Peptizole® will be the main focus of Norbrook’s exhibition at the 2014 British Equine Veterinary Association (BEVA) Congress.
Norbrook® is very proud of the fact that it is the only company in the world which is licenced by the United States Food and Drugs Administration to manufacture sterile injections for veterinary use outside the USA and import them for sale in USA territory. This is an exceptional achievement which underlines not only the company’s outstanding manufacturing capabilities in Northern Ireland but also its unparalleled knowledge and expertise in regulatory and licencing requirements.
Our company is a strong believer that the Veterinary Pharmaceutical industry requires a self-regulatory body which is modelled on tried and tested systems. It is of the utmost importance that this industry takes a responsible approach for Health and Safety of the individual and the Environment and works in close co-operation and synergy with the relevant regulatory bodies.
Our Company is regulated by the Veterinary Medicines Directorate (VMD) and the EMEA; whichever is appropriate in the circumstances. We uphold their standards of advertising and we adhere at all times to their standards of "Safety, Quality and Efficacy". In this way the products we produce are manufactured to the same and/or better standards required of our competitors by the Regulatory Authorities.
We have taken a view not to become involved with any of the existing "trade" member organisations as they do not have any statutory powers devolved from the VMD or EMEA to regulate industry standards or enforce legislation in the public’s interest. In doing so we in no way compromise on the high standards set by the Regulatory Authorities, nor could we choose to even if we so wished. Indeed, our Company prides itself in being the only European company licensed to import its sterile injectable pharmaceutical products into the United States of America. We are able to do this because we have satisfied the very highest standards imposed by the US Food and Drug Administration for this purpose. This is a standard that none of our European Competitors has yet achieved.
Ballyedmond Castle Farm is a key component of Norbrook’s Research and Development. The research farm, which is the only one of its kind in the United Kingdom and the largest of its kind in Europe, provides the ideal environment for confidential research. All studies conducted at Ballyedmond Castle Farm conform to international GLP (Good Laboratory Practice) standards, fulfill the requirements of the regulatory authorities and adhere to relevant legislation.
Arlene Foster, MLA Minister of Enterprise, Trade and Investment has recognised Norbrook’s expertise in Research and Development as well as the company’s innovative new product development in an article that can be found at www.northernireland.gov.uk.
The company is a true innovator and dedicated to novel research and revolutionary processes and products. In true entrepreneurial fashion, Lord Ballyedmond identified an opportunity with the implementation of the Medicines Act 1968 and subsequently pioneered contract manufacturing of pharmaceuticals in the UK. Forty years on, Norbrook continues to lead the world in contract manufacture, by not only meeting the high regulatory demands, but also through an on-going commitment to research and development.
Norbrook’s entrepreneurial spirit continues to be at the heart of the operation today. Its most recent development has been the launch of a revolutionary new product, Closamectin, a unique combination of Ivermectin and Closantel, which is on course to revolutionise the treatment of fluke, worms and lice in cattle and sheep. Available as an injection for sheep and a pour-on solution for cattle, the company anticipate half a billion sales of the product worldwide annually within the next three years. (for more information about Closamectin visit www.closamectin.com)