The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute
Issue link: https://lifescienceleadermag.epubxp.com/i/469672
QUALITY RELIABILITY PRODUCTIVITY REGULATORY INNOVATION K E Y W W W.C M O L E A D E R S H I PA W A R D S .C O M 2015 CMO LEADERSHIP AWARDS WINNERS Company Profiles LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 59 DRUG TYPE: Pharmaceuticals, Biopharmaceuticals DRUG TYPE: Pharmaceuticals, Biopharmaceuticals DRUG TYPE: Pharmaceuticals DRUG LIFE CYCLE STAGES: Research & Development: Preclinical, Clinical (Phase 1, Phase 2, Phase 3) Drug Substance Production: Drug Substance Production Formulated Drug Production: Dosage Form Production, Packaging DRUG LIFE CYCLE STAGES: Research & Development: Clinical (Phase 1, Phase 2, Phase 3) Drug Substance Production: Drug Substance Production DRUG LIFE CYCLE STAGES: Research & Development: Discovery, Preclinical, Clinical (Phase 1, Phase 2) Drug Substance Production: Primary Process Development, Drug Substance Production Formulated Drug Production: Dosage Form Development, Dosage Form Production, Packaging "We were very pleased to have again been recognized by those companies we serve as a leader in the CMO space. This award not only acknowledges our strong regulatory track record through commercialization but also for the scientific innovation we provide clients with our Crystalomics® and Corynex® platforms. Althea takes pride in sharing our client's same unwavering tenacity and dedication towards each project - from clinical testing through commercial success. Thank you for this award." "AMPAC Fine Chemicals (AFC) has established a heritage of successful transition from clinical to commercial production, demanding production quantity and highly energetic APIs. AFC is a recognized partner supporting FDA Pre Approval Inspections for complex drug formulations, commercial drug products, controlled substances, high potency, and energetic compounds. AFC has an aggressive growth program focused on medium scale production quickly configured for specific programs as well as large-scale capacity for major batch and continuous operations." "Our customers use quality as a comparative ele- ment to select and retain their service providers and it differentiates companies on the market place. This award is the result of a company-wide quality improvement initiative that initiated years ago and was further enhanced during 2014. All "quality teams" across the company must work as a seamless organization to address quality best practices and standards on a site-wide model, where KPIs are identified and measured through global metrics." SERVICES & CAPABILITIES: aseptic fill/finish, injectables, liquids, lyophilized products, parenterals (large volume) parenterals (small volume), proteins, solutions & suspensions, sterile, syringes (prefilled), v accines SERVICES & CAPABILITIES: controlled substances, cytotoxic & high potency compounds, generics, injectables, liquids, lyophilized products, non-sterile, ophthalmics, parenterals (large volume), parenterals (small volume), peptides, powders (non-sterile), powders (sterile), proteins, semisolids, soft gels, solid dose, solutions & suspensions SERVICES & CAPABILITIES: capsules, cytotoxic & high potency compounds, generics, liquids, lyophilized products, non-sterile, OTC, peptides, powders (non-sterile), solid dose, solutions & suspensions, sustained release DAVID ENLOE president & CEO ASLAM MALIK president JONATHAN GOLDMAN CEO CATEGORIES WON CATEGORIES WON CATEGORIES WON Aptuit LLC Greenwich, CO www.aptuit.com +39 0458 219 333 or +1 855 506 6360 Paul Overton paul.overton@aptuit.com Key locations: Oxford, UK; Verona, Italy AMPAC Fine Chemicals Rancho Cordova, CA www.ampacfinechemicals.com +1 916 357 6880 Patrick Park AFCbusdev@apfc.com Key locations: La Porte, TX; Rancho Cordova, CA Althea San Diego, CA www.AltheaCMO.com + 1 858 882 0123 Eric Deneroff Eric.Deneroff@altheacmo.com Key locations: San Diego, CA