May 2007 Lisapharma – Confidential 1 Operation – key data  Manufacturing plant and warehouse cover a surface of 6,000 sqm  Workforce of 30 people  Handling in excess of 2,500 references corresponding to 650+ presentations  Production capacity expanded up to 43 mio units  Production lines for:  Injection products - liquids in ampoules and vials, powder in vials  Non-sterile liquids  Semisolids for topical use

May 2007 Lisapharma – Confidential 2 Operation – plant map

May 2007 Lisapharma – Confidential 3 Operation – main equipments  W.F.I. loop distribution system  Purified water loop distribution system  Compressed air distribution system  Nitrogen distribution system  HVAC systems  Continuous particle monitoring system

May 2007 Lisapharma – Confidential 4 Operation – plant overview  Steriles  Liquids in ampoules and vials oSolutions oSuspensions oAseptic filled and terminally sterilized  Powders in vials oAseptically filled sterile powders

May 2007 Lisapharma – Confidential 5 Operation – plant overview  Non-steriles  Liquids  Semisolids

May 2007 Lisapharma – Confidential 6 Operation- production lines  Sterile liquids dept. oSterile 1 - high activity sterile liquid dept – ampoules & vials oSterile 2 – sterile liquids dept. - ampoules & vials oSterile 5 - high activity sterile liquid dept. – ampoules & vials

May 2007 Lisapharma – Confidential 7 Operation - production lines  Sterile powder dept. oSterile 3 - sterile powder dept. oSterile 4 – high activity (cephs derivatives) sterile powder dept.

May 2007 Lisapharma – Confidential 8 Operation - production lines  Non-sterile liquids dept. oPreparation and packaging of non sterile liquids  Semisolids for topical use oPreparation and packaging of semisolids oPreparation and packaging of high-activity semisolids

May 2007 Lisapharma – Confidential 9 Operation - production equipments  Ampoule & vial automatically inspection dept. oAutomatic inspection machine  Packaging dept. oLabelling of ampoules & vials oSecondary packaging dept.  Weighing rooms oWeighing rooms A (API and excipients) oWeighing rooms B (High activity API)

May 2007 Lisapharma – Confidential 10 Quality area  QC & QA account for 13 people  38% university degree, 38% high school degree  Year 2006 quality performance: 800+ batches 2,500+ analysis Handling of 14 product defects with average time of solution and definition of corrective actions, if any requested, of 21 days in accordance to what defined in the relevant SOP (solution required within 30 days from receipt of product defect notice)

May 2007 Lisapharma – Confidential 11 Quality Control  QC activities Acceptance of incoming goods Release of finished products Performance of analytical validation Performance of the stabilities Analytical support for process & environmental validation

May 2007 Lisapharma – Confidential 12 QC departments  Chemical department HPLC assays, UV/VIS spectrophotometric analyses, GLC and TLC analyses, IR spectrophotometric analyses, potentiometric and redox titration, TOC assays, dissolution test, viscometric tests, conductivity and pH analysis, Karl Fischer’s test  Microbiological department sterility testing of obligatory sterile products, determination of the microbial loading of products non-obligatory sterile, qualitative and quantitative LAL test (gel cloth and chromogenic test), microbiological assays, bacterial identification, challenge test, microbiological and particle controls of controlled contamination environments  Classified goods department weight and volume control, primary and secondary packaging material control, finished product control

May 2007 Lisapharma – Confidential 13 Quality Assurance  QA activities Quality system management SOP management Validation protocols of production processes performance Oversee the installation and operating qualification of new equipments and performance qualification of the existing equipments Product defects management APR performance

May 2007 Lisapharma – Confidential 14 Regulatory inspections  Lisapharma plant has a very outstanding record of successful inspections, the most recent carried out by Official Authorities with no observation received, comprises the following:  May 18-20, 2005: Taiwan MoH  April 26-28, 2006: Italian MoH  Audits by customers including MNs’ companies are also regularly performed and successfully passed

May 2007 Lisapharma – Confidential 15 Manufacturing authorization

May 2007 Lisapharma – Confidential 16 Manufacturing authorization

May 2007 Lisapharma – Confidential 17 Manufacturing authorization