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

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 guidelinesin every element of the API-supply chain. All our products (APIs & ingredients) are consistently manufactured to the highest quality standards at trusted cGMP facilities in Europe and Asia.

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

High-quality APIs with full regulatory support for safe pharmaceuticals

Our Products make the difference, so that something good becomes the very best – an extensive portfolio of APIs + Ingredients in all fourteen main ATC-groups

For human & animal health: Our GMP and GDP certificates attest to our high level of quality and safety along the entire value chain – in addition, we have the permission to handle narcotics according to § 3 BtmG.

High-quality is essential in the production of safe and reliable pharmaceuticals. You need purity, consistency, transparency, and quality to guarantee the same in your final products. TIEFENBACHER API + INGREDEITNS is the preferred distributor in the pharmaceutical, veterinary, and healthcare industries. We offer comprehensive range of raw materials (Human + Veterinary) with the highest demand 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 cGMP facilities in Europe and Asia and distributed following Good Distribution Practices (GDP).

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

For further information on medical devices
and drug device combination, please have a look here.

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 (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.

Better Quality to ensure the safety and effectiveness of pharmaceuticals products through high-quality APIs

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 to the pharmaceuticals market. and healthcare. 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, or directly send an email to info@tifi-api.eu. TIEFENBACHER API + INGREDIENTS will follow up with you personally as soon as possible.