Quality assurance is a matter of facts

HIGH-QUALITY ALWAYS COMES FIRST

TIEFENBACHER API 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

GMP / GDP certificate

§64 AMG

registration

100+

audits/ year

supplier qualification

GMP / GDP certificate

§64 AMG

registration

100+

audits/ year

supplier qualification

quality assurance

supplier GMP monitoring

import + wholesaler license

after sales service

quality assurance

supplier GMP monitoring

import + wholesaler license

after sales service

TIEFENBACHER API combines the sourcing and supplying of high-quality APIs with regulatory excellence - all our products meet the required standards and regulations

We have proven quality standards

Supplier Qualification and Audit management

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.

Ensuring high-quality throughout the whole supply chain

Our Licenses

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 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). Since March 2017 TIEFENBACHER API is registered for the distribution of APIs according to § 64 Abs. 3 AMG.

Contact us around our high-quality raw materials (Human + Veterinary) and value-added services

You are benefiting from our global experience and quality-leading position as a pharmaceutical distributor worldwide. Based on a global network of suppliers, we procure highest-quality APIs on the market. Contact us today to find out more about our product and service offerings, with any question, or if we can assist you with a specific application.
Please fill out the contact form below and click “Send message. TIEFENBACHER API + INGREDIENTS will follow up with you personally as soon as possible.