Quality Made In Germany
“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.
Denk Pharma ensures high quality standards through rigorous supplier selection, comprehensive incoming inspections and advanced analytical techniques, with purity and content tests ensuring the quality and efficacy of the active pharmaceutical ingredients. Continuous in-process controls and complete documentation ensure the traceability and safety of our products.
Our quality promise starts at the very beginning of the production process – with the quality control of excipients used.
They meet strict quality standards and are carefully monitored on an ongoing basis.
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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.
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).
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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.
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.
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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.
