Better quality through approved APIs
QUALITY ASSURANCE IS A MATTER OF FACTS
High quality always comes first
TIEFENBACHER API + INGREDIENTS complies with all relevant pharmaceutical industry standards and guidelines.
We are a benchmark company with rigorous regulatory standards. The regulatory landscape around the world is becoming increasingly complex as many countries introduce new systems and certification schemes to safeguard their economies. Our specialists have a deep understanding of regulatory environments and provide a range of services to ensure all regulatory needs. As a pharmaceutical company headquartered in Hamburg, Germany, we are naturally subject to the strict regulations of the German Pharmaceutical Law. We are supervised by the health authorities of Hamburg, so we undergo regular inspections to ensure compliance with the applicable regulations. All our licenses have always been successfully renewed.
HOW WE GUARANTEE BETTER QUALITY AT TIEFENBACHER API + INGREDIENTS
High-quality raw materials with regulatory excellence worldwide
We, at TIEFENBACHER API + INGREDIENTS, know that ensuring the quality, safety, and efficacy of our products is our ultimate task. Therefore, we incorporate quality – based on international standards and pharmaceutical guidelines – in every element of the API-supply chain. All our products (APIs & ingredients) are consistently manufactured to the highest quality standards at trusted GMP facilities in Europe and Asia.
Better access of High quality APIS and Ingredients
An extensive portfolio of APIs + Ingredients in all fourteen main ATC-groups
Tiefenbacher API + Ingredients is the preferred distributor in the pharmaceutical, veterinary, and healthcare industries. We offer a comprehensive range of raw materials (human + veterinary) with the highest demands concerning quality and security in all fourteen main ATC-groups with an EU Drug Master File. All our products (APIs, Ingredients, Excipients) are manufactured at trusted GMP facilities in Europe and Asia and distributed following Good Distribution Practices (GDP). We are reducing supply chain vulnerability by having multiple sourcing options. In addition, we have the permission to handle narcotics according to § 3 BtMG.
Alimentary tract and metabolism
Blood and blood forming organs
Cardiovascular system
Dermatological
Genito-urinary system and sex hormones
Systemic hormonal preparations, excluding sex hormones and insulins
Anti-infective for systemic use
Antineoplastic and immunomodulating agents
Musculo-skeletal system
Nervous system
Antiparasitic products, insecticides and repellents
Respiratory system
Sensory organs
Various
TIEFENBACHER API combines the sourcing and supplying of high-quality APIs with regulatory excellence – all our products meet the required standards and regulations
Supplier qualification and audit management
We have proven quality standards
Quality assurance and qualification verify the quality of the system as ordered in respect of material and documentation. With our experienced inhouse TIEFENBACHER auditors and quality assurance team around the globe we can insure a continuous on-site audit and assessment process at our distinguished new and established manufacturers and logistic partners. Tiefenbacher API performs on an ongoing basis a regulatory GMP monitoring of all released suppliers.
Our licenses
Ensuring high-quality throughout the whole supply chain
Since 2006, TIEFENBACHER API is authorized by the Authority for Health and Consumer Protection Hamburg to perform the GMP compliant service importation of medicinal products. The competent authority of Germany confirms the importer TIEFENBACHER API has been inspected under national inspection program in connection with the manufacturing authorization (EUDRA database) in accordance with Art. 40 of Directive 2001/83/EC transposed in the following national legislation Sect 13 para 1 and sect 72 German Medicinal Products Act (AMG). TIEFENBACHER API complies with the Good Manufacturing Practice (GMP) requirements referred to in the principles and guidelines of GMP laid down in Directive 2003/94/EC. Furthermore, TIEFENBACHER API has an Import license (§ 72 Abs. 1 AMG) and wholesalers license (§ 52a Abs. 1 AMG). This allows us to sell goods already imported in the European Community to EU-customers, so that they do not need to apply for an import license.
Since March 2017 TIEFENBACHER API is registered for the distribution of APIs according to § 64 Abs. 3 AMG.
Pioneering Healthcare since 1963
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High-quality raw materials (Human + Veterinary) & controlled substances for safe, reliable pharmaceuticals