Dynamic Future. Reliable Partnership. Company Profile of the Aenova Group

Transcription

1 Dynamic Future. Reliable Partnership. Company Profile of the Aenova Group

2 Dynamic Future. Reliable Partnership. With a turnover of approximately 1 billion USD, the Aenova Group is one of the leading companies in the global pharmaceutical and healthcare industries. The group s portfolio of services covers the entire value chain for the development and production of all the main dosage forms and product groups in pharmaceuticals and dietary supplements. The Aenova Group s high standards of quality, innovative technologies and clear vision for the future have enabled it to become the global market leader in the business-to-business field. Aenova s aim is to ensure the success of our customers and to enable their business to grow. Our capacity for innovation is the result of significant investment in developing products and processes, together with the ability to react flexibly and quickly to changing requirements from customers and markets. We are focusing on high quality standards, competence and state-of-the-art production technologies, which makes us the partner of choice for the pharmaceutical and healthcare industries. History Established in the Market for nearly 100 years since 2008 as Aenova Group... Merger of Dragenopharm and SWISS CAPS AG to the Aenova Group Bridgepoint Capital holds majority of the Aenova Group Founding Competence Centers: R&D facility Muttenz (CH) Softgel technology Kirchberg (CH) Powder technology Tittmoning (GER) 2011 Opening Packaging technology Bad Aibling (GER) of Aenova Group by BC Partners of Temmler Group of Euro Vital Pharma 2012 Opening of high volume production plant Tittmoning (GER) of InterPharm Arzneimittel 2013 of new Effervescent production facility Bad Aibling (GER) of Haupt Pharma 2014 Adding Competence Centers: Cytotoxics Regensburg (GER) Wolfratshausen (GER) Hormones Münster (GER) Beta-Lactam Antibiotics Latina (IT) Sterile Gronau (GER) Wolfratshausen (GER)

3 Technologies and dosage forms Tablets Tablets Film-Coated Tablets Sugar-Coated Tablets / Dragées Softgel Capsules Gelatin Capsules VegaGels EnteriGels VeganGels Hard Capsules Gelatin Capsules Vegetarian Capsules Effervescent Products Powders Granules Tablets Granules Pellets MUPS (Multiple Unit Pellet System) based dosage form designs for: Modified Release Liquids Pure or Colloidal Solutions Taste Masking Semi-solids Emulsions, Suspensions Ointments Gels Orally Dispersibles Suppositories Rectal suppositories Vaginal ovules Fixed Dose Combinations Injectables Lyophilization Aseptic manufacturing Terminal sterilization Specialty and Containment Production Hormones Cytotoxics Oral Injectables Beta-Lactam Antibiotics Tablets Powders Suspensions Injectables Packaging Services Solids Semi-solids Liquids Injectables Blisters Bottles Sachets Tubes (aluminum, plastic) Jars Bottles Applicators Ampoules Vials Syringes / Injectors

4 Full-Service Portfolio With our unique Full-Service Portfolio we support our partners from development through to logistics. Manufacturing & Packaging Research & Development Qualitymanagement Analytical Services Service & Support Supply Chain Management Research & Development Full-Pharma-Development Formulation & process development Analytical testing of raw materials, intermediates, finished products and stability studies Scale-up studies Manufacturing and packaging of clinical trial batches Product transfers Analytical Services Comprehensive solutions Examination of APIs, excipients and finished products Stability testing Development and validation of methods Method transfer Product release Full-Nutraceutical-Development Development of new products & product concepts Innovative technologies Product development Galenical and analytical development Stability testing Product transfers Supply Chain Management Innovative and integrated supply chain solutions Process control / planning Purchasing Storage Distribution Manufacturing & Packaging State-of-the-art technologies to ensure quality and the highest efficiency for all process stages at all sites Primary and secondary packaging for solid, semi-solid and liquid dosage forms Service & Support Expert consultation and support with Raw materials Pocesses Products Wording and product claims Provision of documents for product dossiers Registrations / notifications Compilation of labels Out-licensing of finished products for the customers distribution

5 Global Presence The company s headquarters are located in Starnberg near Munich. With more than 4,000 employees and 21 sites, Aenova has a growing global presence. GER USA Greensboro Miami IR Killorglin Starnberg Bad Aibling Berlin Brackenheim Bruckmühl Feldkirchen Gronau Marburg München Münster Regensburg Tittmonig Wolfratshausen RO Cornu FR Lyon IT Carugate Latina CH Kirchberg Muttenz (R&D site) Sisseln The Aenova Quality Commitment We operate a fully integrated global Quality Function with an independent and direct reporting-line to the CEO. All sites hold manufacturing licenses for manufacturing of pharmaceutical products issued by relevant authorities. 12 of our non-us based sites are approved by US-FDA. Further approvals include, but are not limited to: Anvisa, TGA, SFDA (Saudi Arabia), K-FDA (Korea), MoH Turkey, PMDA (Japan), Investigational Medicinal products, Narcotic License, Medical Devices, BRC, ISO 22000, NSF, ISF, INFANCA (Halal), ISO 14001, ISO 9001, OHSAS Capacities Dosage Forms 32 billion tablets 22 billion softgel capsules 1 billion VegaGels 3.3 billion hard capsules 1 billion effervescent tablets 10,000 tons powders 2,100 tons liquids 650 tons suspensions 9,000 tons cream & ointment 20 billion suppositories and ovula 4 million single units injectables (vials + ampoules) 532 million single units cytotoxics 220 million single units hormones Packaging 1.5 billion blisters 125 million sachets, stickpacks and strips 45 million bottles (solids) 84 million tubes (creams, gel, ointments) 45 million bottles (liquids) 300 million folding boxes 300 million ampoules 100 million vials 100 million syringes / injectors

6 For further information please contact us: (862) Aenova 8009 Industrial Village Road Greensboro, NC USA Members of the Aenova Group C.P.M. Dragenopharm EVP Haupt Pharma Swiss Caps SwissCo Temmler AEN