Germany, Hamburg

We are certified to deal as a Legal Manufacturer together with ISO 13485-certified contract manufacturing partners and can provide full compliance to all lifecycle activities from batch release to post market surveillance as required per MDR 2017/745 within the healthcare market.

Every year we serve over 500 million patients with our generic, value added and innovative products. All our activities are focused on creating pharmaceuticals – in a patient-centric approach – more available, more affordable, and better than before. To better understand patients´ needs we are in close and regular collaboration with universities and key opinion leaders of all relevant disciplines –getting closer to the patient than ever. Patient insights drive our portfolio strategy of creating a new generation of pharmaceuticals for better healthcare.

Ever since the company was established by Alfred E. Tiefenbacher in 1963, TIEFENBACHER GROUP has been pioneering healthcare to improve patients’ lives around the world. We always challenge the status quo by being one step ahead. We don’t only aim to make high-quality pharmaceuticals better affordable and better available than before; we also strive for better therapies for the benefit of patients. In 2019, TIEFENBACHER PHARMACEUTICALS successfully gained the first European NCE approval for an advanced drug being used to treat the symptoms of insomnia in a better and safer way.

Especially in the generic drug industry, the timing of the market entry is crucial for market success. We at TIEFENBACHER PHARMACEUTICALS always aim to be the first on the market after patent expiry. Thanks to our exceptional experience and expertise in research and development, regulatory affairs, and patent management, we deliver constantly day one-launches. This makes our high-quality pharmaceuticals better available and better affordable for patients around the world at the earliest possible time.

Regulatory Affairs plays a crucial role throughout the lifecycle of pharmaceuticals: from drug development, through the submission of a marketing authorization, to commercialization. We ensure that products are developed, manufactured, and controlled at all levels of expected quality, safety, and efficacy. Our Regulatory Affairs experts provides strategic and technical expertise at the highest level to maintain the goal of timely commercialization of our generic, value added, and innovative drugs. Even after drug approval and commercialization, we ensure that approval is maintained during the product´s life cycle.

Tendering is a common practice for multisource pharmaceuticals in most countries worldwide. TIEFENBACHER PHARMACEUTICALS has a strong track record in winning tenders for its customers.
Through efficient supply chain management and in-house manufacturing capabilities we offer the best prices and a stable and secure supply – being important requirements for a successful bidding process. By ensuring good tender practices, we can make an important contribution to the stability and accessibility of health services, in addition to the efficient use of financial resources.

We license our products to marketing partners worldwide, from local to global and specialized to broad-based pharmaceutical players. TIEFENBACHER PHARMACEUTICALS has over 150 marketing partners in its customers network, including some of the world´s best known pharmaceutical companies. By forming trusted and long-lasting relationships with our customers, we deliver the best and most innovative healthcare solutions for patients worldwide.

We market our generic, value added, and innovative pharmaceutical products in over 80+ countries worldwide – including the United States. We constantly analyze global markets for innovative business opportunities and use in-house capabilities to develop and commercialize pharmaceutical products for local, multinational, and global out-licensing partners. We are experts in adjusting to specific local requirements and customer challenges to ensure that our healthcare solutions make a sustainable impact – for the benefit of patients around the globe.

TIEFENBACHER PHARMACEUTICALS has a strong track record of in-house developing and licensing-out pharmaceutical dossiers to customers, from local to global players. We have already successfully obtained over 15.000 marketing authorizations worldwide. Our experts provide full support to submit marketing authorization applications (MAA) alongside regulatory support to ensure marketing authorizations (MA) are obtained successfully and in a timely manner. After approval, our fully integrated services guarantee the maintenance with all regulations of the products during their lifecycle.

At TIEFENBACHER GROUP we have a broad spectrum of manufacturing capabilities. We have long experience in manufacturing generic drugs of the highest quality and are flexible to manufacture value added and innovative drugs. Product differentiation and innovation are a core business for us to bring better healthcare to the patients worldwide. With our new high potent manufacturing block in India we are now able to manufacture a well-defined and specialized portfolio of highly potent drug formulations in-house. We offer the best technological fit, while also adding significant flexibility to manufacturing capabilities for new generations of pharmaceuticals.

In today’s competitive marketplace, improving supply chain performance is critical to maintaining competitive advantages. TIEFENBACHER GROUP goes beyond manufacturing with a commitment to efficiency and reliability that is anchored in everything we do. We drive efficiency by keeping our supply chains simple and reaching economies of scales in our own manufacturing sites. Our holistic approach includes the whole pharmaceutical supply chain process from API sourcing to planning the whole production process to manufacturing the finished dosage form in our own state-of-the-art manufacturing sites to ensure reliable and on-time delivery.

TIEFENBACHER GROUP owns two state-of-the-art manufacturing sites in Cyprus and India. Both plants are equipped with most up-to-date technologies, highly qualified professionals, and highest safety standards. This ensures full compliance with Good Manufacturing Practice (GMP). We continuously expand in novel technologies and capabilities to improve quality and boost productivity. With our new high potent manufacturing block in India we are committed to drive for growth and innovation and are now able to manufacture a well-defined and specialized portfolio of highly potent drug formulations in-house.

Our in-house facilities are designed to handle state-of-the-art pharmaceutical productions with flexible capacities. The diversity of our technologies, our mastery of processes, and our high quality and regulatory standards allow us to industrialize pharmaceuticals on a small or large scale. We validate and continuously monitor our manufacturing processes to guarantee they function as required. Each of our products is thoroughly tested to ensure it meets product specifications as well as regulatory standards. You can be confident in our ability to manufacture our products and packaging reproducibly and provide the required quality documentation.

Supplementary Protection Certificates (SPC) in the EU can extend the market exclusivity provided by patents by up to five years. With our own site in Cyprus, we are able to produce pharmaceuticals in the EU for an export to non-EU markets or stock pilings before an EU entry during the term of the certificate. This allows us to compete with manufacturers based in non-EU countries (where SPC-type protection is not available or not enforceable).

Up to three billions units can be produced at our facilities annually. We cover all relevant oral dosage forms like tablets and capsules and commercialize our products internationally in line with key regulations. Our own high-performance manufacturing facilities increase speed-to-market on a global basis. With decades of industry expertise and experience from successfully completed development projects, clinical manufacturing processes can also be more easily transferred to commercial production. You can be confident in our ability to manufacture products and packaging reproducibly and provide the required quality documentation.

Good Manufacturing Practices (GMPs) are a compilation of various guidelines and guidance in order to guarantee the highest standards of efficacy, quality and safety in any process that involves the manufacturing of health products. We are certified and regularly audited to these international quality standards as a commitment to our customers. Our Indian manufacturing site has been successfully inspected by the German BGV and the US FDA authorities, among others. Furthermore, both sites have been recently successfully registered by the United Arab Emirates Ministry of Health.

Quality and product safety are as essential to us as to our customers. We’ve built our reputation on staying true to that simple and straightforward principle. We maintain the toughest standards whether based on legislation or self-imposed. These standards include selecting only the highest quality raw materials, ensuring excellence in product manufacturing, and providing efficient and reliable order processing. At TIEFENBACHER GROUP we never cut corners. Our experience ensures compliance with key quality, regulatory and safety requirements, as shown by our impeccable inspections by health authorities. Our customers are always welcome to our facilities to assess and verify our capabilities, as well as our commitment to quality and product safety.

Our very own GMP-warehouse set-up with more than 1.500 temperature-controlled pallet spaces storage for narcotics offers state-of-the-art solutions. The warehouse is centrally located in Hamburg near the airport and harbor, serving as a strategic distribution hub to customers in Europe. We have the expertise to handle projects involving just a few products, as well as complex, large-volume outsourcing-projects.

Since 1963, we’ve built our business by providing high-quality products and value-added service from start to finish with a customer-centric focus for the pharmaceutical industry. We offer a global network of expertise, a trusted partnership, and a solution-oriented approach to business. Most of our customers have been with us for decades. They can rely on our proven capabilities that results in high-quality products and the way we do business – with passion, a focus on excellence and always staying personal.

Since the company was established by Alfred E. Tiefenbacher in 1963, we provided high-quality raw materials for human and animal health with value-added service. We tap into our international network of manufactures to source and offer the latest and optimum performing products (APIs, Ingredients, Excipients) on the market. All products (both volume and niche products) are consistently manufactured to the highest quality standards at trusted GMP facilities in Europe and Asia.

We do not stop at delivering raw material on time, we accompany them throughout the entire life cycle and maintenance to ensure reliable product distribution. By thinking “out of the box”, we also support our partners and customers in making API-processes as simple, efficient, and successful as possible. We offer a comprehensive value-added service to ensure that the drug production never stops and that it is continuously supported by experts throughout its entire service life that guarantees safety and quality for human and animal health.

We work only with qualified manufacturers, whose performance is continuously monitored and evaluated, and who are subject to regular Good Manufacturing Practices (GMP) audits. We maintain a permanent global team of auditors, who perform over 100+ GMP inspections every year on our own. The advantage is receiving one internationally recognized audit by TIEFENBACHER instead of numerous time-consuming audits of various customers. We continuously refine our Quality Assurance (QA) + Regulatory Affairs (RA) programs to ensure consistency in every batch and product we deliver.

The highest demand concerning high-quality, and security were key since our founding in 1963. We adhere to all relevant pharmaceutical industry standards and guidelines from start to finish – from API-sourcing to delivering the right product to the right place at the right time. Quality, safety and efficacy is our ultimate task. Therefore, we incorporate quality in every element of the API-supply chain – and each year our APIs positively impact millions of patients’ lives.

We provide instant access to markets around the world, including the major producing countries in China and India. All our products (APIs & ingredients) are consistently manufactured to the highest quality standards at trusted GMP facilities in Europe and Asia. We also can tailor the quality request of each API to your specific needs. We reduce supply chain vulnerability by having multiple sourcing options for safe, reliably pharmaceuticals.

We manage the distribution of raw material products in compliance with Good Distribution Practices (GDP) from the point of productions to either our own GMP-Warehouse or directly to a manufacturing facility in Europe. We handle every single product with track and trace according to its exact special sensitivity, such as temperature. In short: we are the single source for everything you need. We are delivering the right product in a timely, efficient, and secure manner.

We use in-house capabilities to develop and commercialize pharmaceutical products for global markets and provide several types of dosage forms. These include tablets, capsules, pellets, powders, drops, inhalers and transdermal patches. Developing with a patient-centered approach we are always searching for the dosage form which serves best patients´ needs.

We at TIEFENBACHER GROUP firmly believe that high-quality medicines should be affordable for all patients around the world – irrespective of their income level. Generic products provide a safe, effective, and cost-efficient alternative to reference brands.

Our generics business lies in the development, production, and commercialization of high-quality medicines following the loss of their respective patent protection, thus helping secure access to affordable, quality healthcare for patients around the world. To offer high-quality generic versions of innovative medicines at a fraction of the costs, we drive efficiency in all our business activities – from efficient API sourcing to a lean inhouse development and manufacturing approach to a global market access.

Value added medicines are designed to help patients to better manage their health condition and ultimately lead to better adherence, health outcomes, and quality of life.  This can include less side effects, a better API absorption, better safety, additional product strengths, or new fix-dose combinations – just to name a few examples of our differentiated products. We are constantly developing new product solutions for reaching an unique selling proposition in the market and bringing added value to patients – always with a patient-centric approach.

Our own laboratories with up-to-date technologies and our exclusive global network of development partners enable us to cover all major therapeutics. This includes respiratory, neuroscience, cardiovascular, renal, metabolism, immunology, hepatology, dermatology, infectious diseases, and ophthalmology.  Based on current market needs we are focusing on the field of oncology. For this specific indication we have already 25 leading highly potent drugs in our launch pipeline which are planned to be developed and produced in-house in our new high-potent facilities in Hyderabad, India. 

We have a team of internationally recognized scientists in Research and Development. Their curiosity, their long-lasting experience, their diversity, and their passion for healthcare are the foundation of our success. Our teams of experts work continuously to optimize processes, increase outputs, and reduce timelines throughout the drug development to market access of high-quality pharmaceuticals worldwide

We have successfully developed and marketed a broad range of pharmaceuticals (including both blockbuster and niche products), many of which are leaders in their respective markets. We provide 180+ FDF-products across various therapeutic categories in 10+ dosage forms including highly potent drugs – and additional medical devices.

Quality assurance (QA) is an integral part of TIEFENBACHER GROUP. It ensures a development process which considers all aspects of quality and customer requirements, transparency, and applying good manufacturing practice (GMP). The development projects are performed following ICH, EU, USFDA and other international guidelines. This enables us to generate a corresponding documentation for the submission of a marketing authorization application in the EU, in the US, and further international territories. Our outstanding inhouse intellectual property (IP) competence is a further backbone to guarantee a development process which meets the diverse requirements of our global target market.

Our research and development operations are supported by our own advanced laboratories in Hyderabad, India. It is a GLP/GMP compliant facility and was successfully inspected by the US FDA authorities, the German BGV, the Russian MIT, and the Turkish Ministry of Health. Most modern techniques and softwares (e. g. inhouse XRD Crystallography, WinNonlin IVIVC simulation tools, Nitrosamine testing, Malvern particle size testing) are part of the state-of-the-art equipment. With our new own high potent lab we are able to develop a well-defined and specialized portfolio of highly potent drug formulations inhouse.

We have successfully developed and marketed a range of products (including both blockbuster and niche products), many of which are leaders in their respective markets. We provide over 180+FDF products across various therapeutic categories in 10+ dosage forms including highly potent drugs – and additional medical devices. We are not limited to specific disease areas – we are focusing on what will truly deliver an impact and value for patients – whether for widespread or for orphan diseases.

We market our products in over 80 countries worldwide. We constantly analyze global markets for innovative business opportunities and use in-house capabilities to develop and commercialize pharmaceutical products for local, multinational, and global out-licensing partners. We are experts in adjusting to specific local requirements and customer challenges to ensure that our healthcare solutions make a sustainable impact – for the benefit of patient around the globe.

We are a purpose-driven and 100% family owned health care company providing best-in-class solutions along the entire pharmaceutical value chain. From initial idea to market access of high-quality pharmaceuticals for people around the world: We distribute APIs and develop, manufacture, and register finished dosage forms including highly potent drugs as well as medical devices

Ever since the company was established by Alfred E. Tiefenbacher in 1963, we are pioneering healthcare to improve patients’ lives around the world. We always challenge the status quo to be one step ahead – in terms of business models as well as concrete products and services. This entrepreneurial spirit is firmly anchored in our founder and owner family being the driving force of achieving better health solutions worldwide

From initial idea to market access of high-quality pharmaceuticals for patients: We distribute APIs and develop, manufacture, and register finished dosage forms (FDF) including highly potent drugs as well as medical devices. Our GMP and GDP approved own facilities in India and Cyprus attest to our high level of safety and quality along the entire value chain.

With our API and FDF business we serve in total over 400 customers worldwide. In our FDF business we develop, manufacture, and register generic, value added and innovative medicines and license them out to marketing partners worldwide. In our API business we distribute a full and complementary range of high-quality raw materials and value-added services to the European pharmaceutical industries.

The greatest strength of TIEFENBACHER GROUP are our people. We believe that their curiosity, their passion for healthcare, and their diversity are the driving force of achieving better health solutions. We welcome the diversity of nationalities, languages, cultures, and lifestyles in which we work together as one organization – that’s how we have a positive and effective impact on one another throughout the entire organization.

We are pioneering healthcare to improve patients´ lives around the world. Every year we serve over 500 million patients with our generic, value added and innovative products. All our activities are focused on creating pharmaceuticals – in a patient-centric approach – more available, more affordable, and better than before.

Our more than 800 employees at our locations in Germany, India and Cyprus come from over 20 different countries around the world. We believe that different personalities enrich us and we highly appreciate seeing things from different perspectives – a great environment to thrive and grow. Our unique company structure enables us to deliver high-quality pharmaceuticals worldwide and to contribute to a better tomorrow.

We believe that high-quality medicine should be affordable and available to everyone – irrespective of their income, their origin or their nationality. We also believe that there are always new ways of smart medicines which better deliver on patients ́ needs. That’s why all our activities are focused on creating pharmaceuticals more available, more affordable, and better than before. We drive everything from a patient-centered approach – in close collaboration and alignment with universities and key opinion leaders of all relevant medical disciplines.

We believe that we can only improve patients’ lives when we perform at our best together. That ́s why we concentrate with our 700 diverse, highly skilled employees worldwide our curiosity and passion and use our experience of almost 60 years in the pharmaceutical industry to deliver best-in-class solutions along the whole pharmaceutical value chain. By working together as TIEFENBACHER GROUP, in flexible and agile cross-functional structures, we tap into our full potential, drive our success, and stay at the forefront of our field.

We believe that the most important driver for our pioneering role is curiosity – the curiosity of each of our employees dedicated to make patients ́ life better. That ́s why we are always challenging the status quo and striving for novel healthcare solutions – in terms of business models as well as concrete products and services towards the benefit for patients.Thanks to the constant curiosity of our employees, we’ve always been pushing the boundaries of what’s possible, and we’ll continue to do so in the years to come.

Entrepreneurial thinking and flat hierarchies were already important to our inspiring founder, Alfred E. Tiefenbacher back in 1963. We still believe that true passion for what you do arises, when you can bring in your personality and your experiences in what you do. It gives you the courage and motivation to make decisions that help both you and the company move forward to improve patient’s live worldwide

Our healthcare business is developing dynamically and so are we. Therefore, we support our employees in permanently improving their own skills and strengths. We offer professional and need-based education, online and offline, to successfully meet current and future healthcare challenges. We believe that the access to affordable medicine is a human right.

The TIEFENBACHER GROUP is a family-owned healthcare company and is today owned by the direct descendants of the founding father Alfred E. Tiefenbacher. We put our passions to improve peoples’s live into action and want you to enjoy coming to work every day. Working at the TIEFENBACHER GROUP is characterized by mutual appreciation, fairness and transparency. A career with us means working for a company that values you and your well-being.

We are managing the entire innovative process to resolve development hurdles within a product lifecycle. We solve complex engineering challenges for medical devices to medical equipment engineering initiatives by working cross-site collaboration in the development processes, and the use of synergies. The control of all interfaces between medical device and drug product development including all necessary design verification and validation activities but also design transfer and process implementation is our key expertise and supports lean and efficient timelines and costs on the way to successful market access in our core regions EU + US.

We believe that better therapy and innovative medical devices as well as eHealth solutions does not necessarily mean higher costs. We guide and execute along a strategic pathway, focusing on product excellence, quality and regulatory compliance with patient-centric solutions that enhance the efficacy, safety and compliance of the treatments, for a controlled overall therapy cost.

We ensure through certification a high level of safety and reliability for compliance with the legal requirements. Our certification confirms the effectiveness of our quality management system for design, development and manufacture of medical devices. We establish our processes in compliance with the current global regulations such as ISO 13485:2016 and MDR 2017/745.

We understand the regulatory and care environment in each respective region. Winning digital solutions cannot be developed as one-size-fits-all solutions. With evolving global regulations, establishing regulatory frameworks is of essential importance to drive successful practices and control strategies throughout the combination product lifecycle, to assure public health. We strive to continuously enhance our regulatory and quality expertise in the pharmaceutical and medical device industry.

We drive all players in the healthcare ecosystem to develop highly patient-centric solutions. We benefit from our global network of developing partners, analytical test houses, raw material suppliers, contract manufacturing partners, consultants and customers, which enables lean and well-organized development strategies and supports arranging new innovative and digital technologies.

We participate in a highly innovative segment to maximize patient outcomes while minimizing healthcare spends. Combination Products leave developing companies with various challenges and commercial risks with the interfaces between medical devices engineering and medicinal product development. As part of the TIEFENBACHER GROUP, we ensure reduced time to market by meeting all regulatory guidances and technical aspects. The skilled R&D and RA personnel significantly de-risk the product in early development, as well as reduce the number of questions from the reviewing agencies.

We contribute to the digital transformation and have the skills, knowledge, and power to tackle all critical issues and leverage the full potential in medical devices and eHealth. Interdisciplinary work is what characterizes us. Exchanging closely and making decisions quickly, we take this advantage to implement innovations very effectively. Our entrepreneurial spirit is a mindset that embraces critical questioning and continuous improvement.