Local Site to Support Global Product Demand.
KREMS, Austria, December 13, 2018 – Merck Animal Health (known as MSD Animal Health outside the US and Canada), a division of Merck & Co., Inc., Kenilworth, N.J., USA, today announced two significant milestones in its continued effort to expand manufacturing capacity and capabilities at its large-scale, vaccine production facility with product formulation and filling capabilities in Krems, Austria. The site, which is expected to be fully operational in 2023, recently received the Government Manufacturer’s Authorization and the Certificate of Good Manufacturing Practices (GMP) of a Manufacturer, which will allow the company to begin test manufacturing operations.
The Krems site, which was acquired in 2017 by Merck Animal Health, is part of a manufacturing network that supports the company’s global leadership position in the Animal Health market. The site will include state-of-the-art production capacity for vaccines, integration of new technologies and manufacturing processes, as well as upgraded environmental, health and safety considerations for employees and the community.
“We are committed to develop our manufacturing capacity and capabilities, including our advanced technology, to help meet the increased global customer demand for our innovative products,” said Dr. Martin Kern, Plant Manager, Krems facility. “The Manufacturer’s Authorization and GMP Certificate have great symbolic significance for Merck Animal Health and our Krems manufacturing facility, because it is the first time that we will be able to produce pharmaceuticals and vaccines at this site. Receiving these designations by the Governnment and Industry underscores our ongoing dedication to ensure that our products will be of exceptional quality and our continued commitment to meet and exceed the industry’s highest safety standards. Through this effort, we will be able to fulfill customer demand for our portfolio of animal health products.”
Vaccines play an important role in protecting animal and public health. Timely and effective vaccination reduces the incidence and severity of disease, enabling efficient production of food animals.Vaccines also have had a significant iimpact on the health of pets, preventing serious illnesses and helping them live longer and healthier lives.
“As a leader in delivering innovative pharmaceuticals and vaccines to advance animal health and meet growing customer needs, this investment in people, technology and equipment reflects our commitment to produce a range of vaccines and pharmaceutials for animal health diseases,” said Joseph Morrissey, Senior Vice President, Animal Health Manufacturing, Merck Animal Health.
Krems Site Designations
The company was issued a Government Manufacturer’s Authorization following a thorough, several-day inspection by the Austrian Agency for Health and Food Safety (AGES) for the Austrian Federal Office for Safety in Health Care (BASG) under the Austrian Medicinal Product Act (AMG). The Manufacturer’s Authorization refers to manufacturing and control of veterinary medicinal products, which are sterile products and other biological medicinal products.
The company also was granted a Certificate of Good Manufacturing Practice (GMP) Compliance of a Manufacturer under European Directive 2001/82/EC. The GMP Certificate attests that a manufacturer is compliant with applicable manufacturing principles and guidelines based on thorough plant inspections.
Merck Animal Health Global Commitment
Merck Animal Health continues to invest in expanding its manufacturing facilities with a recent, continued expansion of its manufacturing, packaging and warehousing facility in Milton Keynes, United Kingdom, for blending and filling of poultry vaccines; an existing facility for production of poultry vaccines using SPHEREON® technology in Salamanca, Spain; and a recently announced construction phase of a state-of-the-art facility in Boxmeer, The Netherlands, for sterile fillng and freeze drying of vaccines. Additionally, Boxmeer is one of the company’s centers for the development and production of veterinary vaccines, including other production and research facilities in Boxmeer and De Bilt. The company recently announced an acquisition of a privately owned, animal health vaccine company in China, with an advanced manufacturing facility for the China market.
About Merck Animal Health
For more than a century, Merck, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Merck Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA, is the global animal health business unit of Merck. Through its commitment to the Science of Healthier Animals™, Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services.
Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets.