Quality Made In Germany

Our quality promise starts here

“Quality for your health – Made in Germany“ – Ensuring premium German quality is the guiding principle of our actions. Denk Pharma offers exactly the same quality to every customer worldwide as they would find in a German pharmacy.

Denk Quality

Starting with the choice of raw materials, including the active pharmaceutical ingredients (APIs), continuing throughout the production process and manufacture of products to transport to the customer, all processes are subject to strict quality controls.

Active Pharmaceutical Ingredients

Our quality promise starts at the very beginning of the production process – with the quality control of the active pharmaceutical ingredients (API´s) used.

The active ingredients in our products meet the strict german quality standards. They’re carefully monitored on an ongoing basis.

Secure production
Our primary and secondary packaging materials meet strict standards to ensure the stability and safety of the medicines. We use packaging materials that are suitable for extreme climatic conditions and have been tested for their suitability in different climate zones. They are also selected according to individual product requirements.

Our secondary packaging materials and export cartons ensure that our products reach over 80 different markets in excellent condition.

Comprehensive stability studies, in accordance with the guidelines of the International Conference on Harmonization (ICH), are available for all products. Ongoing stability studies of our products are carried out for different climatic zones to ensure quality until the expiry date.

The packaging of the tablets in blister packs also contributes to hygiene and user-friendliness.

Quality assurance

Computer systems integrated into the production process guide, control and document every step of the production process, which is carried out by trained personnel.

Each finished product is manufactured, checked and approved by our Qualified Person for compliance with relevant legal requirements (EU GMP guidelines, marketing authorization).

The specifications and verification methods according to the marketing authorization comply with the requirements of pharmacopoeias (e.g. European Pharmacopoeia, EP or United States Pharmacopeia, USP).

Dissolution tests are carried out to ensure perfect absorption of the active ingredient.
Our laboratory is state of the art. Over 25 HPLC units are available to analyze the finished products.

Logistics

In accordance with the European Good Distribution Practice (GDP) guidelines, medicinal products must be sourced from a qualified supply chain and stored, transported and marketed under appropriate conditions as stipulated by the marketing authorization or product specifications.

We transport our premium quality products worldwide by air, sea and land. Our products are delivered to various climate zones, including high temperatures and high humidity. Our products are transported properly in order to deliver premium quality. Temperature loggers are used to ensure that the temperature remains within a certain interval. These are mobile measuring instruments for recording temperatures during the transportation of our products over a defined period of time.
Pharmacovigilance
Drug safety (pharmacovigilance) aims to improve patient safety with regard to the use of medicines. According to the World Health Organization (WHO), pharmacovigilance encompasses the science and activities related to the detection, understanding and prevention of adverse drug reactions and all other drug-related problems. Pharmacovigilance means continuous benefit-risk monitoring and the initiation of necessary measures.

Denk Pharma maintains a pharmacovigilance system in accordance with the current European GVP (Good Pharmacovigilance Practices) guidelines. Our measures include the collection, assessment and reporting of relevant cases (spontaneous cases and literature reports), literature research and the preparation and creation of regularly updated safety reports.

Through continuous benefit-risk monitoring and the prevention of adverse drug reactions, drug interactions and other drug-related problems, our aim is to protect the health of our patients.

Generics: Identical active ingredient as the originator

After the patent on an original medication expires, pharmaceutical companies can bring to market drugs with the same active ingredient as the original medication. These drugs are known as generics (singular: generic).

Generics are medications whose active ingredients are identical to those of the original drugs. There may be differences in the excipients or manufacturing technologies used. However, this does not affect their effectiveness. During the approval process, this is ensured through the examination of bioequivalence.

Ensuring the safety of our patients is our top priority.
To achieve this, we implement a comprehensive quality strategy in the manufacture of our medicines. By using tested raw materials, employing competent and qualified staff, and utilizing high-quality production machinery, we prevent risks such as contamination, inconsistent quality, and inefficiencies. Moreover, accurate documentation and strict quality assurance measures ensure that our products consistently meet the highest standards and deliver optimal efficacy for our patients.
Dr. Kim Eck
Project Manager Manufacturing

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Denk Pharma Germany

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Note on the product portfolio

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