Partner with the Global Leader in Drug Delivery Systems.

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1 3M DRUG DELIVERY SYSTEMS Partner with the Global Leader in Drug Delivery Systems. Hurlingham, Argentina Manufacturing Facility Experts at Commercializing Innovation

2 Drug Delivery Systems: It s in the detail As a pioneer in the development of intuitive, patient-friendly technology, 3M understands how to deliver life saving medication. From development to commercial scale manufacturing, we have over 50 years of knowledge and innovation that goes into everything we do. You can t always see our innovation, but look again, because it is there in the detail. Inhalation Nasal Microneedle Reducing the risk of commercializing innovation Gain an edge in your nasal market Increasing commercial success with patientfriendly solutions 3M is a global innovation company that never stops inventing. Over the years, our innovations have improved daily life for hundreds of millions of people and businesses all over the world. Every day at 3M, one idea always leads to the next, igniting momentum to make progress possible around the world. On average, every person will come into contact with a 3M product or technology 17 times a day. Having created the first metered dose inhaler (MDI) over 50 years ago, 3M has the experience and expertise to help commercialize your product. We offer MDIs with the 3M Integrated Dose by Dose Counters, a full range of inhaler components, and provide both pressureand cold-fill contract manufacturing. Featuring no-drip aerosol delivery, 3M Nasal MDI technology is ideal for partners wanting a rapid, cost-effective extension of their inhaled product and for those seeking a device edge for new nasal treatments. 3M Microstructured Transdermal Systems (MTS) offer patient-friendly solid and hollow microneedle technology. By offering patients the efficiency of a syringe with the comfort and convenience of a patch, these technologies can help increase the commercial success of your product. Electronics & Energy Consumer Health Care Innovation on a Global Scale With subsidiaries in more than 70 countries and operations in nearly 200 countries, 3M is truly a global company. Currently, 3M offers more than Oral & Topical A partner you can trust, quality you can count on 3M is your low-risk contract manufacturing partner for a broad range of oral and topical dosage forms, offering security, service and sound value with end-to-end solutions you can trust. Worldwide Manufacturing Facilities Capabilities Inhalation Cold-fill Inhalation Pressure-fill St. Paul, MN Northridge, CA Loughborough, UK Hurlingham, AR 60,000 products which generate sales in excess Transdermal Industrial of US$ 30 billion. And with almost 90,000 employees worldwide, 3M has local presence across its global markets. 3M has five global Transdermal Optimize delivery and increase patient comfort Oral/Topical Pilot scale Ingenious Solutions Transforming Health Safety & Graphics business groups, one of which is Health Care. A transdermal form of your drug can help to differentiate your product while offering patients a more comfortable, convenient and effective way to receive their medications. Small scale Intermediate scale Large, commercial scale ISO-7 certified DEA CII-CV compliant With a depth of diverse technologies, a culture of collaboration and a global footprint, 3M Health Care is a leader in delivering innovative solutions. As the creators of the metered dose inhaler, the Drug Packaging Films Reliable packaging delivers confidence Clinical supply manufacturing Toxicology supply manufacturing Delivery Systems division has a proven history of inhalation delivery. At 3M Health Care and 3M Drug Delivery Systems, our innovations help improve the quality, cost and outcomes of care. 3M Scotchpak Packaging Films can withstand every part of the product lifecycle delivering a high level of confidence, even for the most challenging applications. Inspections FDA, MHRA FDA, MHRA FDA, MHRA MERCOSUR, INVIMA

3 3M Hurlingham, Argentina: Local Knowledge, Global Resources With more than 30 years of knowledge, experience and success in Latin America, 3M Hurlingham offers a dedicated local team backed by a truly global support network. We can navigate cultural barriers, provide custom technical dossiers and help you understand requirements and filing processes, not only within Latin America but across global markets. Let our highly responsive local team reduce the risk of commercializing your next metered dose inhaler. With state-of-the-art cgmp pressure-fill and cold-fill capabilities, global regulatory support and an MDI product portfolio covering Latin America s needs, we are the trusted local partner of choice. Technical Expertise to Get You to Market Faster Our team has the experience, capacity, and extensive quality and regulatory expertise to support our customers through every step of the product commercialization process: High Quality Production and Reliable Supply 3M understands metered dose inhaler (MDI) manufacturing from start to finish. We ask better questions and use Lean Six Sigma processes to get you ready for market faster. Because we offer both pressure-fill and cold-fill for MDI manufacturing, 3M leverages the most appropriate processing method for your product. We also provide custom micronizing, or particle size reduction, to obtain particles in the respirable range. Our filling capabilities can handle any size project from clinical to commercial supply. With a culture that demands continuous improvement, 3M is the reliable choice for cgmp compliant MDI manufacturing. We are always looking for ways to maximize efficiencies. Whether it s through better supply chain management, reinvestment in new technologies or Lean Six Sigma processes, our goal is to streamline operations, eliminate variation and give our customers a competitive edge. MDI pressure-fill and cold-fill capabilities Micronization and powder handling technologies Strategically located filling sites with supply and distribution to global markets Screening one or more compounds for compatibility with one of our drug delivery technologies. Evaluating formulation, process and component variables in the feasibility phase. Feasibility studies provide partners with confidence to progress to full product development and commercial scale up. cgmp contract manufacturing capabilities offering flexible batch sizes to support market needs. Regulatory support with a proven track record including four single-cycle FDA reviews in five years. Local presence, with a deep understanding of the unique culture and regulatory processes in the region. Vertical integration providing flexibility, speed and reliability for a seamless and cost-effective customer experience. Proven experience bringing a wide range of branded and generic inhaled drug products to market in Latin America. Globally-compliant facilities that are always audit ready Automated aerosol filling and packaging lines including small-order packaging flexibility We are experts at commercializing innovation. So with our proven technical, regulatory and production experience, you can proceed with total confidence. At 3M Hurlingham, we are experts at commercializing innovation. Laboratory Pilot Facility Commercial Facility Certifications: Formulation Assess feasibility of delivering API through solubility, compatibility and prototype system pharma performance Early Phase Refine the system for optimum performance, product toxicology and early clinical supplies Full Finalize design Complete method validation Scale up process Produce late-stage clinical supplies Commercial Supply Complete registration stability Submit regulatory dossier Produce validation & launch supplies ANMAT (Argentina) INVIMA (Colombia) Mercosur (Argentina, Brazil, Paraguay, Uruguay & Venezuela) ISO and OHSAS (EHS)

4 3M Hurlingham Capabilities, Services and Quality Control Capabilities Modern, state-of-the-art current Good Manufacturing Practices (cgmp) facility (opened in 2006) ISO 6 class clean areas in manufacturing and ISO 7 class in packaging Controlled temperature and humidity Cold-filling and pressure-filling (one step) capabilities Closed manufacturing processes, reactors fitted with Clean-In-Place (CIP) Automatic filling under class 3 laminar flow 100% aerosols tested by automatic valve spray testing and dynamic weight checker Automatic and semi-automatic packaging process Technical Services Product formulation Analytical Methods and Validation Process scale-up and validation Stability studies in different climatic zones Preparation of Technical Dossier for Regulatory Submission Analytical Laboratory Physical-Chemical Laboratory New generation instrumental: High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), ultrapure water generator, Mastersizer particle size analyzer, ultra analytical scale, Andersen cascade impactor, stability chambers for different climatic conditions Microbiological Laboratory Bio-security cabinet, autoclave and incubators Quality Assurance World class quality systems implemented Finished product complete release Lean Six Sigma Complaints Management Change Management Deviations and Quality Incidents Management Internal and Supplier Audits Corrective and Preventive Actions (CAPAs) Annual Product Review Materials & Warehouses Validated systems for materials management Clean sampling area ISO 6 class Temperature-controlled warehouse (<25 C/<77ºF) 200 standard locations expandable to 800+ Flammable products warehouse Use of heat treated wooden pallets From Start to Finish, 3M is the Best Partner for All Your MDI Manufacturing Needs: 3M is a stable company to select for your product supply 3M has the global capacity for development and commercial manufacturing 3M has a commitment to quality and continuous improvement Business Card 3M has over five decades of proven success in MDI development, manufacture and delivery to market. Contact us at to receive an initial, cost-free paper feasibility assessment and to begin partnering with us to commercialize your MDI innovation.

5 About 3M Argentina 3M Argentina was founded in 1952 and was the eighth subsidiary outside the United States. We have local manufacturing operations in Buenos Aires and Tierra del Fuero provinces, a distribution center as well as the new Innovation and Technology Center in Buenos Aires. 3M Argentina Los Arboles 842, Hurlingham (1686) Buenos Aires, Argentina (54) Additional Facilities 3M Northridge Nordhoff Street Northridge, CA USA (1) Fax (1) M Center Building E-10 St. Paul, MN USA (1) Fax (1) M House Morley Street Loughborough, Leicestershire LE11 1EP England (44) Fax (44) M is a trademark of 3M Company. 3M All Rights Reserved Versión en español disponible Experts at Commercializing Innovation www.

Partner with the Global Leader in Drug Delivery Systems.

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