GSK Verona Presentation Pack May 2012

GSK Verona  Sterile vial fill and packaging Manufacturer of cephalosporin products for GSK and 3 rd parties  Global Supplier for Sterile Cephalosporins  Flexible Partner, focused on Customer’s needs, ensuring quick responses and smart solutions  Reliable Organization, recognized for the highest quality standards adopted, with a continuous improvement mindset

Brief Description of Site Capabilities  4 aseptic filling lines equipped with the most advanced technologies and complying with the most stringent regulatory requirements;  Filling capability to cover a wide range of vial sizes: 10ml, 17ml, 26ml, 60ml, 77ml, 127ml plus Add- Vantage presentations;  10 secondary packaging lines, for final customization; presentations with and without solvent, in single or multi-pack cartons;  Dedicated organization for artworks development;  Expertise in anti-counterfeiting measures design and application.

Verona Regulatory Accreditations  Approval by all major Regulatory agencies: European Union, USA, Japan, Canada, Brazil, etc.  FDA approval for sterile dosage since 1983;  Last FDA inspection received in 2011 with no 483;  High Protected Risk (HPR) Site certification since 2001;  Regulatory approval for clinical trials manufacturing.

GMS Verona – Performance Profile Regulatory and compliance profile External inspections with no critical observation since 2004 GMS Verona never experience a recall related site operations Customer service Long records of delivery performance > 98% ( delivery time +/- 3 days ) Patient profile Justified Customer complaint rate inf. 1ppm International Recognitions In 2009 Verona has earned an Honourable Mention in the 2009 Facility of the Year Awards* for the revamping of aseptic powder filling facility 4 at the site, representing an evolution of aseptic powder filling operations Internal Performances OEE aseptic filling ops: > 70% OEE secondary packaging ops >50% Active Yield: >97%

GMS Verona - Products ACTIVE IngredientDose FormBrand Name Sodium Cefuroxime Vials for injection (17,26ml) Zinacef Curoxim Vials for infusion (77,127ml) Monovial (18ml)/Advantage (22ml) Ceftazidime Vials for injection (17,26 ml) Fortaz/Fortum Glazidim Modacin Vials for infusion (60, 77,127 ml) Monovial (18 ml)/ Advantage (22ml) Intradermal Reaction Kit (10 ml) Ceftriaxone Cefoxitin Cefazolin Vials for injection (17, 26 ml) Ceftriaxone Cefoxitin Cefazolin Vials for infusion (60, 127 ml)