PMPN_Pharmaceutical & Medical Packaging News

Pharmaceutical & Medical Packaging News, July/August 2015

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46 • Pharmaceutical & Medical Packaging News July/August 20XX Company Name Address City, ST ZIP Tel: 000/000-0000 Fax: 000/000-0000 E-mail: Web site: Key Personnel: Name Title Company Logo DESCRIPTION The global healthcare industry trusts PCI for the development solutions that increase their products' speed to market and opportunities for commercial success. Only PCI brings the proven experience that comes with more than 50 successful product launches a year and over four decades in the healthcare business. Leading technology and continued investment enable us to address our clients' global development needs throughout the product life cycle, from preclinical development through clinical trials, commercialization, and ongoing supply. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients' lives. FACILITIES PCI serves the global drug development market with specialized facilities based in North America and Europe, providing localized pharmaceutical services and support for products destined to over 100 countries globally. Our state-of-the-art cGMP facilities feature primary and secondary packaging suites, with ISO 8 clean rooms and site segregation including Schedule II-V Controlled Substances, Cold Chain, Animal Health, Hormonal products, Penicillin products, Cytotoxic, and SafeBridge TM Band 1– 4 potent compounds. Facilities support Cold Chain packaging requirements including controlled ambient 15-25˚C, 2-8˚C, -20˚C, -80˚C, and -196˚C, low humidity packaging, as well as modifi ed environments for oxygen and light sensitive products. Facilities are audited by FDA, MHRA, as well as the world's leading pharmaceutical and biotech manufacturers. On-site Research and Development Laboratory Services include Analytical development and testing, Stability testing, Microbiological testing and import testing for EU requirements, with facilities located both in the US and UK. PRODUCTS AND SERVICES DRUG DEVELOPMENT: PCI of ers full service Formulation Development including Analytical Development/ Characterization. CLINICAL TRIAL SERVICES: PCI supports investigational medicines with Tablet, Capsule, Powder and Liquids Manufacturing, Analytical Development, Stability Testing, Clinical Packaging and Labeling including product Blinding and Randomization, Global Storage and Distribution, as well as Returns Management and Destruction. COMMERCIAL SERVICES: PCI supports Commercial drug manufacturing including Commercial scale-up. We of er Packaging Services for a broad range of delivery forms including Oral Solids, Powders, Liquids, Creams, and Gels, as well as Injectable and Parenteral Delivery forms including Device Assembly. In support of commercial supply we of er Analytical Testing and Stability services. POTENT COMPOUNDS: PCI provides manufacturing and packaging services for clinical and commercial medicines. The recently opened state-of-the-art, purpose-built, contained manufacturing site handles potent compounds with OELs down to 0.01µg/m3. This facility was recognized by ISPE as a Facility of the Year in 2013. Potent compound manufacturing is further supported by segregated, purpose-built packaging facilities in both Europe and North America. RECENT DEVELOPMENTS • August 2014 PCI completes acquisition of Penn Pharma • September 2014 PCI completes acquisition of Biotec Services International Packaging Coordinators, Inc. Corporate Headquarters 3001 Red Lion Road Philadelphia, PA 19114 Tel: +1 215 613 3600 North America 4545 Assembly Drive Rockford, IL 61109 Tel: +1 815 484 8900 2200 Lake Shore Drive Woodstock, IL 60098 Tel: +1 815 206 1500 Europe Wye Valley Business Park Hay-on-Wye, HR3 5PG, UK Tel: +44 (0) 1497 820829 Penn Pharma, a PCI company 23-24 Tafarnaubach Industrial Estate Tararnaubach Tredegar, Gwent, NP22 3AA, UK Tel: +44 (0) 1495 0711222 Biotec House, Western Avenue Bridgend Industrial Estate Bridgend, Mid Glamorgan, CF31 3RT, UK Tel: +44 (0) 1656 750550 E-mail: Web site: Key Personnel: Bill Mitchell, President and CEO Bill Bolding, Chief Operating Off cer Mitch Blumenfeld, Chief Financial Off cer Richard Yarwood, Sr. VP International Phil DiGiacomo, Sr. VP Sales & Marketing Robert Misher, Sr. VP Global Clinical Services 46 • Pharmaceutical & Medical Packaging News July/August 2015

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