Global contract manufacturing

To tackle the emerging pharmaceutical markets set to experience high growth in demand, manufacturing competence that meets quality standards is required. This is particularly important in the area of sterile products and packaging.

Nycomed operates 19 manufacturing facilities in 13 countries that are meeting the highest international quality standards. A combination of central and regional manufacturing ensures rapid response to opening new markets and expansion in existing markets. It also includes a significant volume of contract manufacturing, optimising utilisation of manufacturing facilities. Partnership plays a vital role for all operational activities and helps to guarantee that products not only reach exactly the right customers, but also reach them in the most efficient manner possible.

The company’s manufacturing technologies range from sterile and nonsterile liquids to semi-solids and solids. Two of its four competence centres, located in Austria and Germany, have long-lasting experience in sterile production. These state-of-the-art facilities are not only specialised in the filling of glass ampoules and vials in large quantities, but also in the filling of syringes. Nycomed’s Norwegian plant complements this sterile portfolio with various primary packaging concepts in blow-fill-seal.

One of the fastest-growing markets for Nycomed’s brands is Eastern Europe, with Russia and CIS showing significant growth potential for one of the major sterile products in glass ampoules, manufactured in Austria.

Employing an international team of 500 people, Nycomed Austria in Linz is not only the competence centre for sterile ampoules but also the competence centre for biological products. The company possesses great expertise in the processing of biologics, whether the products are of animal or human origin. The largest product at Linz requires the handling of more than 3,800t of calf blood per year. Furthermore, Nycomed Austria is permitted to handle narcotic drugs and drug substances.

Due to the increasing demand in emerging markets a fourth ampoule filling line has been installed at the Austrian plant. Having an additional line means its three-shift capacity is increased by 40% – from 180 million ampoules to 260 million ampoules per year, mainly depending on format mixture.

To enable utmost flexibility, the four ampoule filling lines are equipped with format parts covering a range from 1ml to 25ml for filling volume. According to product requirements aseptic filling as well as terminal sterilisation can be applied.

Besides manufacturing its own brands, Nycomed Austria offers its competence and experience in manufacturing of sterile ampoules to external partners. With more than 40 years of experience in the contract manufacturing business, it serves a client base of 25 customers from emerging to big pharma. Its service covers the whole supply chain from careful sourcing of raw materials over efficient production of the bulk material to specific secondary packaging and the timely delivery of the final product.

Pharmaceutical packaging
Ampoules are placed into plastic trays formed by deep drawing. Fully automated high-performance labelling machines put self-adhesive labels onto each ampoule and scanning devices as well as balances check for the presence and integrity of labels and the filling accuracy. The trays are subsequently packed in boxes including leaflets, according to customers’ specific requirements.

Nycomed is continuously improving its anticounterfeit programme for secondary packaging by applying RSS 14 barcode and / or special safety labels. The company is investigating innovative systems for identification of each and every unit delivered to the market.

All products are manufactured and packed with regard to the existing European GMPregulations and other national standards. The plant is currently heading for an FDA inspection. All of this allows Nycomed to develop economically sound and reliable solutions for contract manufacturing of products of highest quality, safe and convenient.

Company profile

Nycomed is a global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.

For further information, visit: www.nycomed.com.