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Flamma Bergamo, Italy, and Boston, MA www.flammagroup.com (617) 515-0975 DRUG TYPE: Pharmaceuticals Manufacturing locations: Chignolo d'Isola, Bergamo, Italy (cGMP), Dalian, China (non-cGMP), and Isso, Bergamo, Italy (cGMP) Contact: Kenneth Drew, Ph.D. director, U.S. sales and business development flamma2012@flammagroup.com DRUG LIFE CYCLE STAGES: Research & Development – discovery, pre-clinical, & clinical (phase 1, phase 2, & phase 3) SERVICES OFFERED: Analytical development, cGMP manufacturing, contract manufacturing of NCEs and APIs, generics, peptides, process R&D;, and scale-up. SERVICES OFFERED: Non-sterile, proteins, and vaccines. DRUG TYPE: Biopharmaceuticals Fujifilm Diosynth Biotechnologies Morrisville, NC www.fujifilmdiosynth.com (919) 337-4400 Manufacturing locations: Billingham, Teesside, UK, and Research Triangle Park, NC, U.S.A. Contact: Jozef Orpisz ewski enquiries@fujifilmdb.com DRUG LIFE CYCLE STAGES: Research & Development – pre-clinical, & clinical (phase 1, phase 2, & phase 3) Drug Substance Production – primary process development and drug substance production "Flamma is appreciative to be recognized for our ability to be innovative. A CMO Leadership Award is evidence that Flamma consistently works with our customers by treating them as if they are family. Flamma relies on its expertise in high value chiral materials (specifically, amino acid related materials) to be a difference maker and problem solver for difficult projects. Flamma is a fully integrated company with production facilities located in Europe and China. Check us out." — Kenneth Drew, Ph.D., director, U.S. sales and business development Gallus BioPharmaceuticals, LLC St. Louis, MO www.gallusbiopharma.com (314) 426-5000 DRUG TYPE: Biopharmaceuticals DRUG LIFE CYCLE STAGES: Research & Development – pre-clinical and clinical (phase 1, phase 2, & phase 3) Drug Substance Production – primary process development and drug substance production Formulated Drug Production – dosage form development and dosage form production SERVICES OFFERED: Aseptic fill/finish, process development, proteins, and vaccines. Manufacturing location: St. Louis, MO Contact: Shelly Adams shelly.adams@gallusbiopharma.com DRUG LIFE CYCLE STAGES: Research & Development – clinical (phase 2 and phase 3) Drug Substance Production – primary process development and drug substance production Formulated Drug Production – dosage form development, dosage form production, and packaging "Gallus is delighted to be recognized in the CMO Leadership Award for its innovation, productivity, and regulatory performance. Gallus is innovating with the first Xcellerex 2000L FlexFactory™ installed in the U.S. to provide highly flexible clinical manufacturing capacity. Gallus' productivity is epitomized by its 10-year history of commercial manufacturing, with over 200 commercial batches of product manufactured for 75 countries. This is enabled by an outstanding regulatory record with a recent no-483 FDA inspection." — Mark Bamforth, president and CEO 40 The CMO Leadership Awards 2012 SERVICES OFFERED: Aseptic fill/finish, capsules, controlled substances, creams & ointments, cytotoxic & high-potency compounds, generics, injectables, liquids, lyophilized products, non- sterile, ophthalmics, OTC, parenterals (large volume), peptides, powders (sterile), proteins, semisolids, solid dose, solutions & suspensions, sterile, sustained release, syringes (pre-filled), and topicals. "GSK is very pleased to receive this award and the recognition it brings to our efforts to be a pharmaceutical company that offers a trustworthy and dependable manufacturing service. We are invested in our partnership approach, listening to our customers and understanding their business requirements. GSK knows how important it is to continually deliver value in the eyes of the customer, and we look forward to building upon this success." — Kristof Szent-Ivanyi, business development director DRUG TYPE: Pharmaceuticals and Biopharmaceuticals "In our first year of operation as Fujifilm Diosynth Biotechnologies, we are delighted to be recognized for our regulatory reputation. Quality underpins everything we do to ensure patient safety and this is exemplified by our successful inspection history at both our U.S. and UK sites. As a global leader in the contract development and manufacture of biopharmaceuticals, we look forward to building on this reputation." — Stephen Spearman, Ph. D., MBA, president GlaxoSmithKline Brentford, Middlesex, UK www.gsk.com/collaborations 44 (0) 20 8047 5000 Manufacturing locations: Australia, China, Europe, Japan, North America, and South America Contact: Russell Harris russell.b.harris@gsk.com DRUG LIFE CYCLE STAGES