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Landsteiner Scientific
,embracing life with the certainty that even the impossible may be achieved and with the solid purpose of providing solutions that respond to healthcare, while being innovative and of excellence. Our company, with more than 15 years of experience, and as a result of the work and commitment of a multidisciplinary team of professionals, the automation of innovative processes run under strict quality measurement systems and the continuous drive towards research for new drugs, has been able to link advances in biomedical research with technology in order to develop treatments that improve the patient’s health and quality of life, as well as providing the medical force with better diagnosis and treatment options. In our constant search for surpassing the limits of what is possible, we have found external collaborators that share our beliefs and with whom we have developed strategic research ties that will further thrust our growth, allowing us to be at the top of the great world advances in the field of pharmacology. We have accomplished these due to our pledge on being a Socially Responsible Corporation (ESR for its Spanish acronym), committed to the well being of our social and natural environment. Being able to see those first dreams come true, affirms that our obligation is to continue dreaming, citing Gabriel García Márquez: “Sooner than later, reality ends up agreeing with imagination” .
Board of Directors
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OurCompany Landsteiner Scientific is a Mexican pharmaceutical company founded in 1998, dedicated to manufacturing, distribution and marketing of health products. Our name is taken in honor of the Austrian born, U.S. citizen Karl Landsteiner, who in 1930 received the Nobel Prize for Physiology and Medicine for his research in hematology and immunology. Today, Landsteiner Scientific employs over 1,000 collaborators and we supply Mexican and international markets with the following product lines: • Landsteiner, line of prescription products • Elite Medical, line of generic products • Biotechnology • Government Sector • High Specialty • Private brands • Licensing • Exports • Genomic Medicine
Landsteiner Scientific stands out for its research and development of drugs in specific therapeutic areas, for which it maintains quality controls in accordance with world models. The Drugs manufactured by Landsteiner Scientific are produced under the strictest quality controls existent in Mexico, the United States and Europe, with certified procedures that are based on the Best Manufacturing Practices. All of these supervised by an internal audit program run by the Quality Assurance Area. With the awareness that ethics, quality, excellence and social responsibility are fundamental in the pursuit of our objectives, in Landsteiner Scientific we have undertaken specific actions geared towards contributing to the well being of the Mexican population through products and services that provide a better quality of life.
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Mission Statement To contribute to the well being of society through the ethical and professional development of innovative products of excellence for the benefit of healthcare.
Vision To be a recognized corporation for its national and international growth; driven by its biotechnology products, integral programs and diversification of business lines; engaged with maintaining excellent quality ratings, client service and employee development.
Objectives To maintain and increase the actual levels of client and consumer satisfaction, as well as guaranteeing a sustainable long-term operation, based on efficient management, marketing and financial operations, surrounded by a framework of value creation. To promote and maintain the required levels of excellence demanded by the scientific and technological progress of medicine, within an ethic and humanistic approach. To provide health professionals, through the efforts of group work, the necessary tools for the continuous development of medical education and research.
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Ourpurpose To contribute to the self-sufficiency of the national demand for medicines through Mexican enterprises, to social wellbeing and health care. To accept and face the permanent challenges of a health system with growing needs. To continuously strive to consolidate our growth plans, in accordance with the needs of the population and with a social benefit. To invest in infrastructure and technology, the development of new products and the permanent training of human resources is our goal. To bring excellent health products close to the population is the mission that inspires our motto.
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CorporateCulture Our success lies among our people, so that in Landsteiner we not only respect diversity and value its richness, but we are also an inclusive company where the opinion of each one of our collaborators is important. We practice this same philosophy with our suppliers, we look for diversity without neglecting the standards they must meet to achieve the best possible result. Work opportunities are the same for all qualified candidates. We promote passion in what we do and recognize the importance of every person’s work. We measure our results individually, by division and of the overall company.
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ResearchandDevelopment At Landsteiner Scientific we create and develop the best products for the pharmaceutical industry, always backed by the rigor of the most advanced investigation and technology, with the purpose of supporting the medical professionals as much as possible in regards to prevention, diagnosis and treatment of diverse illnesses and thus improving the quality of life of their patients. The different stages for the creation and development of new products include:
1. Investigation 2. Pharmaceutical Development 3. Development of Analytical Methods 4. Pre-Formulation 5. Formulation 6. Production of Pilot Batches 7. Stability Studies 8. Scientific and Technical Documentation
9. Protocols and Pre-Clinical and Clinical Studies 10. Sanitary Registration 11. Production 12. Quality Control 13. Marketing 14. Client Service 15. Pharmacovigilance
Bioterium Landsteiner Scientific is one of only three pharmaceutical companies in Mexico, with in-house, certified Bioterium installations, that comply with the Mexican Technical Standards NOM-062-ZOO (Technical specifications for the production, care and use of animal labs), with the National Certification of the Mexican Agriculture and Animal WellFare Agency SAGARPA (Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación) and with the International Certification AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care); in regards to installations, procedures and specialized animal laboratory staff, we are certified by CONCERVET, the National Council on Veterinary Medicine (“Consejo Nacional de Certificación en Medicina Veterinaria y Zootecnia”). These characteristics allow us to work under the best conditions, both for the well being of the animals as for the success of the efficacy and security tests of our drugs
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Technology In Landsteiner Scientific we have a systems department specialized in operation technologies. We have implemented the SAP system, in charge of maintaining the company operations procedures in optimal conditions, such as: supply chain, medicine production, financial processes, radiofrequency controlled warehouses and bar code scanning through optical readers, among others. We use the MES (Manufacturing Execution System) floor control system, one of the most advanced automation systems in the pharmaceutical industry, in charge of control of each phase of production, from the weighing of raw materials to delivery of final product. We execute an exhaustive monitoring of the production of our products through tablets located in each production room; this allows us to follow and control the manufacturing process of medicines in each of its phases. In our Toluca Campus, our critical systems are automatically monitored through a SCADA system, which makes it possible for us to immediately respond to any contingency if such arises. Our automated mass data back up system gives us the opportunity to have the historical information of our company at hand to ensure continued operations in case of contingencies.
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Biotechnology Is the technology involved with the use of live organisms or composed organisms obtained from them, with the objective of obtaining valuable products for human beings. Biotechnology’s history dates a few years back with the manufacturing of bread, wine, cheese, yogurt and beer. However, with the discovery of the DNA’s structure by Watson and Crick in 1953, the terminology “Modern Biotechnology” emerges, defined as the commercial application of live organisms or their products, in which the deliberate manipulation of their DNA Molecules occurs. Landsteiner Scientific is focused in the investigation, development, production and marketing of biotechnology drugs for human use, with the objective of strengthening and increasing the therapeutic tools available today. These high specificity drugs are capable of healing diseases that years back had no cure or of considerably improving the quality of life of those persons suffering illnesses for which there is still no treatment available. From the early stages of investigation to the production of each biotechnology drug, we use equipment with the latest technology, guaranteeing that each product complies with the specifications required by the norms and is obtained under the strictest worldwide quality standards. Biotechnology investigation at Landsteiner Scientific has incorporated to its main objectives the development of a particular group of molecules, now-a-days very limited in Mexico, called “Monoclonal Antibodies”. To pursue this challenge we have signed agreements with well-recognized University Centers with whom we share the leadership of this investigation. We make a special effort to guarantee an Academic-Enterprise relationship under a collaboration plan that is oriented to fulfilling the main development needs of our country in this important field.
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GenomicMedicine We entered into this field of medicine through investing in the Spanish company Neopharm Obesity. A strategic move that allows us to locate therapies with a greater probability of success, directing the development and production of medicines to high prevalence illnesses in Mexico and Latin-America, such as cardiovascular, oncology, neurodegenerative an obesity illnesses. This effort is supported by the cooperation of international Institutes that allow us to ensure that the therapeutic developments include the application of results on the Mexican and the Latin population in general, addressing health demands imposed by the epidemiologic transition. The objectives of this project are: • • • •
Create products based on genomic medicine. Identify genomic variations in the individuals who associate with predisposition to illnesses. Use genomic variations on patients to predict the severity and the nature of the complications of their illnesses, as well as to predict their response to the treatment (efficacy, adverse reactions and optimal dose). Use genomic variations of greater prevalence in a determined population to provide adequate treatment.
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Pharmacovigilance Since our foundation in 1998, in Landsteiner Scientific we acquired the commitment to provide the medical community and, in consequence to their patients, with safe and effective medicines. To insure this commitment, we conduct the Landsteiner Scientific Pharmacovigilance program, through the “Unit of Pharmacovigilance”, authorized by the National Center for Pharmacovigilance (“Centro Nacional de Farmacovigilancia”(CNFV)). The objectives of our program are: to identify, register and follow any adverse reaction that could arise with our medicines. The knowledge of the Pharmacovigilance of our products, allows us to prevent and be warned about possible adverse reactions, identify new ones and avoid risks in the population. As the technology applied to the pharmaceutical industry advances, we have had the possibility of achieving better developments, that have changed the way to treat and fight diseases, as well as allowing greater efficacy in their general treatment. In this way we contribute to preserving the quality of life of the patients.
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CommittedwithourEnvironment At Landsteiner Scientific we are very conscious about the importance that the environment has in the lives of human beings. This is why we have made a commitment to avoid or reduce waste and emissions, to use and to eliminate residual substances in ecological ways and to implement products that are harmless to nature. We pursue a compatible development with the future and we firmly believe that this must involve economic growth, environmental responsibility and social commitment.
Clean Industry Certification We have been awarded a distinction for Clean Industry (“Industria Limpia”), issued by the Mexican Environmental Protection Agency (“Procuraduría Federal de Protección al Ambiente” (PROFEPA)), whose objective is the development, promotion and practice of new and improved instruments of ecological policy. In this sense, the purpose is to encourage the business sector to protect the environment in an integral manner and in more profound ways than what legislation demands. Aware by the importance that the environment has on the life and health of human beings, Landsteiner Scientific reasserts its commitment to eliminate all residual matter in ecologically friendly ways and to guarantee that the products do not cause environmental damage.
LEED Certification (Leadership in Energy & Environmental Design) The Landsteiner Scientific Campus is the first pharmaceutical plant in Latin America to obtain LEED Certification, issued by the U.S. Green Building Council. This voluntary Certification searches to evolve in the use of strategies that allow an improvement on the environmental impact of the construction industry in topics such as: energy efficiency, use of alternative energies, improvement of interior environment quality, water efficiency, sustainable development of open spaces and selection of materials.
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QualityControl In Landsteiner Scientific quality is a priority, this is why it would not be possible to do our job without guaranteeing that each product meets the defined parameters of the strictest international quality standards. We have an area of control, integrated by specialists, who based on a policy of total quality and following good laboratory practices, verify and certify the fulfillment of the required procedures. In our company we fully comply with the guidelines established by Mexican National Norms, such as: NOM-059SSA1-1993 for good manufacturing practices and NOM-073-SSA-2005 for medicine stability; as well as international standards: ISO 9001:2008, Good Manufacturing Practices (GMP’s), the U.S. Food and Drug Administration (FDA), EMA (European Medicines Agency) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Quality Systems Landsteiner Scientific’s Quality Control System (“Sistema de Gestión de Calidad” (SGC)), is based on complying with the NOM-059-SSA1-2013 for Good Manufacturing Practices for Medicine, the ISO 9001:2008 guidelines and WHO’s 32nd Report; all of these strengthen and consolidate subsystems like Annual Product Audit, Change Controls, NonConformities and CAPAS, vendor evaluation, registry control and documents and liberations of raw materials and products. Simplifying and standardizing operations and integrating independent processes, we improve the traceability and reliability of them. SGC’s policy and objectives for quality are oriented at the identification and satisfaction of the requirements of our clients, providing products that meet the strictest standards of quality.
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Certifications Our collaborators are meticulously selected, trained and continually updated in their knowledge areas, under an Internal Program for Continuous Improvement. Thanks to the contribution and commitment of the Landsteiner Scientific team, we have obtained the highest certifications, which translate into safe and effective products: ISO 9000 Certification. International Certification of Quality Systems, S.C. guarantees on an international level, the fulfillment of quality of the products and certifies that we have a system that generates safety and confidence. Clean Industry (“Industria Limpia”). Issued by the Mexican Secretary for the Environment and Natural Resources (“Secretaría del Medio AMbiente y Recursos Naturales” (SEMARNAT)) through the Mexican Environmental Protection Agency (“Procuraduría Federal de Protección al Ambiente” (PROFEPA)), after complying with the requirements of a strict environmental audit. INVIMA. Certification granted by the Colombian Institute for Surveillance of Medicine and Food (“Instituto de Vigilancia de Medicamentos y Alimentos de Colombia“), which authorizes export of products into their country. MEG 2009. Is a Model of Equality of Gender. Granted by the Mexican National Institute of Women (“Instituto Nacional de las Mujeres”). Great Place to Work. Certification that endorses the efforts to transform our organizational culture and improve the quality of life of our collaborators. ESR Socially Responsible Company (“Empresa Socialmente Responsible”). Acknowledges our efforts in achieving operations that are economically, socially and environmentally sustainable, while integrating values such as respect for others, ethical values, community and environment. FDA U.S. Food and Drug Administration. The Agency responsible for protecting public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. EMA European Medicines Agency. The responsible Agency for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.
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ISO9001 With the objective of guaranteeing that each product complies with international quality standards, Landsteiner Scientific is certified on ISO 9001:2008, granted by the International Certification of Quality Systems, S.C. group, which confirms that we have a quality and continuous improvement system, that provides safety and confidence of the quality of each medicine. This way, we assure a model based on the prevention of mistakes. With the objective of strengthening the quality system, we certified a group of people as internal auditors, who carry out several audits every year to detect areas of improvement.
Validation Having validated processes in Landsteiner Scientific represents quality, safety and productivity. Validation is the documented evidence that proves that through a specific process we can obtain products that consistently comply with the established quality specifications; it is a rigorous process that demands studies on risk analysis and potential and real repercussions for a product, in cost, quality and control.
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CommercialRelationships Landsteiner Scientific has given special attention to developing new commercial relationships, purchasing projects and product lines that provide niches of opportunity. We are in continuous search for elements and research projects to complement our portfolio of products. Through the years we have formed strategic alliances with different international institutions with the objective of offering the market a greater access to relevant products. A fundamental part is the creation of synergies with other countries to implement the transfer of technologies and foster our growth.
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Exports In response to our commitment of delivering our products to the people who need them and due to the success we have achieved in this, we decided to continue expanding our efforts beyond our national boundaries. Our Export department is concentrated in pushing and strengthening the growth of our company in foreign markets, while contributing to economic and social improvement in our country as well as in countries abroad. We make an effort in learning about the different international markets with a marketing strategy that allows us to be part of a competitive high quality Mexican offering of medicines. We are present in Central and South America with a wide portfolio of medicines that comply with registration requirements of the Sanitary Authorities of the countries we sell to, and we continue several registration processes in others. Our objective is to become one of the important key players in Latin America’s pharmaceutical industry. We will continue with a business focus that allows us to consolidate our presence in other markets like the United States, Europe and Asia.
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LandsteinerCampus We built the Landsteiner Campus, a vanguard project that enables Landsteiner Scientific an important growth and evolution in the areas of research, development and production. Landsteiner Campus has more than 20 thousand square meters of construction inside Parque Industrial Toluca 2000 (Toluca 2000 Industrial Park). The main areas that conform it are: Distribution Center, Research and Development Building, Areas for Production of Solids and Semi-solids, Parenteral and Oncology. The new production areas have been created with strict abidance to national and international guidelines and rules, under excellent manufacturing criteria and new technologies; among these, stand out: Pelletization, Nanoparticles (solids – semi-solids), Microemulsions (parenteral – topic) and Liberations of osmotic type, allowing us to increase our production capacity and the entrance into new markets. The projected capacity of production for the company is 115 million pieces, this represents an increase of 760% over the current installed capacity. The Distribution center will have vanguard installations that will optimize he logistics operation. We reinforce our commitment with the environment. During the process of planning and construction of the Campus, we have taken decisions that put attention to the energetic resources, environmental quality, election of raw materials for construction and efficiency in the consumption of water, making the project 100% sustainable. All of these have been carefully designed with the purpose of obtaining the national sanitary license of productive processes by the FDA and the international certifications EMA and Gold LEED, with the objective of exporting our products worldwide.
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Investors Landsteiner Scientific in the Mexican Stock Exchange Landsteiner, for the first time in the pharmaceutical industry, has issued Bond Certificates in the Mexican Stock Exchange. This is a characteristic of the best Mexican enterprises, those who distinguish themselves for their quality, vision, stability, professionalism and transparency, open to providing all of the necessary information to the investors that trust their resources to them.
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Foundations As an effect of the acquired experience of being involved in healthcare, we created several non-profit organizations with the objective of aiding the Mexican child and youth sectors through programs that contribute to the integral development of their capabilities.
The Landsteiner Foundation for Health Improvement Concerned by the impact that overweight and obesity have on Mexico’s young population, we created a program called “Camp Ten” (“Campamento Diez”), with the objective of giving children and teenagers belonging to families with low income, as well as to their parents, the necessary education tools to prevent the complications derived from eating disorders; as well as providing permanent medical, nutritional and psychological consultation aimed towards bringing about changes in their lifestyles that they can apply to their family and social environment.
The Landsteiner Foundation for Sports This Foundation supports the development and growth of high performance athletes in Mexico, with permanent economic incentives. It’s objective is to detect, develop and promote the growth of athletes with real possibilities of obtaining top places in national an international competitions; as well as communicating and facilitating the awareness of their achievements in each competition.
We dream like you, we feel like, and as you, we embrace life.
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CompanyDirectory MEXICO CORPORATE OFFICES Av. Periférico Sur No. 4118, Piso 6 Col. Jardines del Pedregal C. P. 01900 México, D. F. Tel. (55) 5449 3690 Fax. Ext. 3668 landsteiner@landsteiner.com PHARMACEUTICAL PLANT Calle 6 Norte Lote 14, Manzana H Ampliación Parque Industrial Toluca 2000 Tel. 01 722 276 90 30 Tel. 01 722 249 21 32 al 35 LANDSTEINER CAMPUS Prolongación 4 Norte No. 234 Manzana F, Lote 18 Parque Industrial Toluca 2000 Toluca, Estado de México, C.P. 50200 Tel. 01 722 276 41 50 Tel. 01 722 249 74 68 DISTRIBUTION CENTER Prolongación 6 Nte. No. 206-A, Lote 12, Manzana 410 Ampliación Parque Industrial Toluca 2000 Tel. 01 722 249 73 05 al 07
GUADALAJARA OFFICES Av. Américas No. 1619, Piso 11, Oficina 1 Col. Providencia 1a Sección C. P. 44630 Guadalajara, Jalisco. Tel. (01) 333 8 173 897 MONTERREY OFFICES Av. Constitución 1800 Pte. 1er Piso, Local A4 y A5, Col. Obispado C. P. 64060 Monterrey, Nuevo León. Tel. (01) 818 3 339 727 Fax. (01) 818 3 339 667 LANDSTEINER SPAIN NEOPHARM OBESITY Avenida de la Palmera 27-29, 3°A. Edificio ARTTYSUR. 41013 Sevilla, España +34 (954) 23 89 39 USA OFFICES 1002 Wood Sage Dr. Chapell Hill, N.C. 27516 Ph/Fax (919) 942 0967