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 of APIs
HIGH-QUALITY RAW MATERIALS WITH REGULATORY EXCELLENCE
GMP / GDP certificate
§64 AMGregistration
100+
audits/ year
supplier qualification
GMP / GDP certificate
§64 AMGregistration
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 – Speak to a team member:
You are benefiting from our global experience and quality-leading position as a pharmaceutical distributor. 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.
