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    ALFRED E. TIEFENBACHER (GmbH & Co. KG)
    Van-der-Smissen-Strasse 1
    22767 Hamburg
    Germany

    Phone: +49 40 – 44 18 09 – 0
    Fax: +49 40 – 44 18 09 – 26
    Mail: info@aet.eu

    • About Us
    • Raw Material
    • Research & Development
    • Manufacturing
    • Medical Device
    • Market Access
    • Careers
    • News
    • Imprint
    • Privacy

    Alfred E. Tiefenbacher (GmbH & Co. KG)
    Van-der-Smissen-Strasse 1
    22767 Hamburg
    Germany

    Phone: +49 40 – 44 18 09 – 0
    Fax: +49 40 – 44 18 09 – 26
    Mail: info@aet.eu

    • About Us
    • Raw Material
    • Research & Development
    • Manufacturing
    • Medical Device
    • Market Access
    • Careers
    • News
    • Imprint
    • Privacy

    © 2020 Alfred E. Tiefenbacher (GmbH & Co. KG)

    10+ Dosage forms


    several types

    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.

    generics


    cost-efficient generic drug development

    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 and innovation medicines


    New generation of pharmaceuticals

    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.

    major indications and highly potent drugs


    an innovative portfolio pipeline

    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. 

    150+ R&D Scientists


    our center of excellence

    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

    180+ FDF Products


    Dossiers developed /under development

    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 and intellectual property


    legal framework & compliance

    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.

    Own laboratories with FDA approved


    stat-of-the-art inhouse development

    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.

    180+ FDF Products


    Dossiers developed /Under development

    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.

    80+ countries worldwide


    Medical innovations & healthcare solutions

    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.

    Family owned


    Pioneering healthcare since 1963

    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

    Pioneering Healthcare


    Since 1963

    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

    100% entire pharmaceutical value chain


    High-quality pharmaceuticals 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.

    400+ Customers


    Pharmaceutical Out-Licensing and API distribution

    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.

    800+ employees worldwide


    curiosity, passion for healthcare, and diversity

    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.

    >500million patients


    served every year

    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.

    FAQs for using the WHISTLEBLOWER PLATFORM

    What is whistleblowing?

    Whistleblowing is the indication of a grievance or misconduct either in the company or in the supply chain with the intention of preventing damage to the TIEFENBACHER GROUP.
    Whistleblowing can be done confidentially and anonymously. To avoid possible negative consequences for the whistleblower, the whistleblower’s safety is guaranteed by using our digital platform saved in the cloud in Germany.

    What sort of reports will help TIEFENBACHER GROUP?

    Compliance with laws, regulations, ethical and environmental standards is part of our positive and open corporate culture.
    You may be aware of harmful behavior or risks which endanger the TIEFENBACHER GROUP. We are interested in facts so that potential misconduct can be resolved before any harm occurs. Your report will help to quickly identify financial losses and reputational damage and will also ensure the company’s sustainable success. Please report about violations in terms of quality and safety standards for our products, human rights, environment, data protection and IT security, finances or any other serious compliance concern. Our Whistleblower Platform can be used by anyone, anywhere, anytime.

    How can I report violations of the law?

    With the Whistleblower Platform of TIEFENBACHER GROUP, violations of the law can be reported confidentially and anonymously. Whistleblowers can log in via the link on our websites and submit their report using predefined questions or free text. Additionally, photos or files can be uploaded.

    There are several steps to the reporting process:

    • First, you will be asked to read some information on the protection of your anonymity.
    • On the next page you will be asked about the main topic of your report.
    • On the report page, you can describe the incident in your own words and answer some questions via a simple answer selection. Next, you can use a free text field and attach a file. Please bear in mind that documents may contain identifying information about the author, so to stay anonymous please check file names and the file properties information.
    • Before submitting the report, you can decide whether you want to provide your contact information or remain anonymous. The platform works like a locker that can be accessed from two sides. You will be asked to set up a personal PIN and then a 16-digit access code will be generated automatically. Please note these login details with which you can log back into the locker later. The TIEFENBACHER GROUP thus has the opportunity to make inquiries. The locker can only be accessed by the whistleblower with the login details and should therefore be kept in a safe place.

    Please do NOT use any technical device such as a PC or smartphone that has been provided by your employer to submit your report, instead please use your private equipment – or rather public places like internet cafés and hotels in order to completely exclude any possible technical traceability.

    If you already have submitted a report, you can access it directly via the “Login” button.

    How do I receive feedback and remain anonymous at the same time?

    The overriding principle of the Whistleblower Platform of TIEFENBACHER GROUP is to protect the whistleblower. The system’s anonymity protection function is certified by an independent body.

    If you lose your login details, please submit a new report and set up new access credentials. As this will be a new inbox, you cannot see the content of your previous report.

    Your report is anonymized using encryption and other special security routines. You will never be asked for personal information during the reporting process. Please do NOT use any technical device such as a PC or smartphone that has been provided by your employer to submit your report, instead please use your private equipment – or rather public places like internet cafés and hotels in order to completely exclude any possible technical traceability.

    The ombudsman of TIEFENBACHER GROUP, an external body, will contact you via the secure inbox to provide you with feedback on the status of your report or to ask questions if details still need to be clarified – you will remain anonymous throughout the dialogue. We are interested in reports to avoid damage or a loss, not in you as a whistleblower.

    Who can see my notice?

    Reports can only be seen by by our ombudsman, an external lawyer who manages the Whistleblower Platform for the TIEFENBACHER GROUP. The platform operator has no access to the information. Our ombudsman will initiate the next steps.

    What happens after I have given a hint?

    Within one week the ombudsman of TIEFENBACHER GROUP will leave a confirmation of receipt in the locker. You may be contacted to investigate the case further. After 3 months at the latest, the ombudsman of TIEFENBACHER GROUP will inform you by leaving a message in the safe locker about how your report has been dealt with. Therefore, please keep the PIN in order to be able to log in again. If you have not been informed of the result after 3 months, you should take the case to the public. Your protection as a whistleblower is guaranteed as long as you do not go public with your report within these given deadlines.

    How secure is the data at TIEFENBACHER GROUP's Whistleblower platform?

    Your data is safe with us! The highest level of security for your data is a matter of course for us and an indispensable requirement for successful whistleblowing solutions. The Whistleblower Platform of TIEFENBACHER GROUP is GDPR-compliant and the certification by TÜV and DIN ISO 27001 is currently being implemented. The system is hosted by Deutsche Telekom. Information on the cases can only be viewed and processed by our ombudsman. Whistleblowers can use an individual PIN to view the data relating to their report and the TIEFENBACHER GROUP’s responses. Beyond that, nobody has access to the information.

    Patient Health and Safety


    Highest quality standards for our products and processes

    Our Goal:
    We strive to guarantee highest quality standards for our products and processes to fulfill our purpose of improving patients´ lives in a sustainable way. We aim to maintain a robust quality system with harmonized processes to ensure patients´ health and safety.

    Examples of our quality measures within TIEFENBACHER GROUP:
    • GxP compliance
    • Quality control and pharmacovigilance as integral parts of our development and manufacturing processes
    • Highest safety standards of our plants: ISO 14001 and ISO 45001 certifications
    • Official accreditations of our locations (e. g. BJV for our Hamburg site and US FDA, Russian MIT, and Turkey MOH approvals for our Indian site) as well as frequent inspections by leading pharmaceutical companies

    International Environment


    Multicultural work environment & diversity

    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.

    Climate and Resource Protection


    Environmental responsibility in all our activities

    Our Goal:
    We strive to make efficient use of natural resources, to minimize the environmental impact of our operations, and to invest in environmental solutions that protect biodiversity. We aim to improve our eco-balance in three key areas: water, waste, and energy.

    Examples of our green initiatives:
    • Solar energy and water recycling facilities at our R&D and manufacturing sites
    • Reduction of carbon emissions by using green energy in Hamburg, supporting public transportation, and the use of bicycles and electric cars
    • Use of sustainable paper, bottles, water, coffee, and milk in our everyday office life

    Societal Engagement


    Contribution to our communities

    Our Goal:
    We aim to care about our society – especially in the countries where our company operates. Our caring culture is fundamental to achieve our purpose to make life significantly better for people around the world.

    Examples of our community engagement projects:
    • New school building next to our Indian site in Hyderabad
    • Support of India in the fight against the post-covid disease “Black Fungus” with Posaconazole tablets
    • Financial support of the world’s leading conservation organization WWF
    • Financial support of the non-profit organization “Stiftung Mittagskinder” (Children Lunch Foundation)

    Human Rights, Ethics, and Governance


    Highest ethical standards in our business practices

    Our Goal:
    We aim to ensure that TIEFENBACHER GROUP acts in compliance with applicable regulations, laws, policies, and guidelines. We aim to promote ethical and trustful behavior by all employees of TIEFENBACHER GROUP.

    Examples of initiatives anchored in our code of conduct:
    • Anti-discrimination and anti-child labor policy (compliance with ILO standards)
    • Compliance with competition and antitrust laws
    • Anti-bribery and anti-corruption guidelines and prevention of money-laundering

    Working Environment


    Health and safety for our employees – Diversity and inclusion for stronger teams

    Our Goal:
    We strive to offer a safe working environment and to protect the health of every employee. We also aim to create a diverse and inclusive workplace where every one of us can be our best and true selves.

    Examples of our measures:
    • Workplace safety by a comprehensive occupational safety program
    • Data safety by a profound IT system and regular trainings
    • Health protection by company doctor, vaccination program, massages as well as sports programs
    • Equal opportunities, inclusion, and diversity as central parts of our employer management
    • Flexible working time-models, regular trainings, and career development

    Patient centered


    Value by Innovations

    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.

    Excellence focused


    Know-how by enthusiasts

    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.

    Curiosity driven


    Achiever by pioneership

    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.

    Entrepreneurship


    Empowering your ambitions & curiosity

    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

    Training & Career


    Lifelong learning

    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.

    Family-owned


    Pioneering healthcare since 1963

    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.

    Highly efficient R&D
    project management


    Verification and validation

    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.

    Affordable medical
    devices


    Maximizing patient’s outcome

    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.

    Legal Manufacturer
    acc. to MDR


    Best-in-class solution

    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.

    ISO 13485 certified


    Highest quality standards

    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.

    Regulatory Requirements


    Full compliance

    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.

    Global B2B network


    for innovative and digital technologies

    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.

    Combination product engineering


    Full potential of healthcare solutions

    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.

    Dynamic, aspiring Team


    Entrepreneurial spirt

    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.