Production & Control
We focus on high quality production and control. Read more about our active pharmaceutical ingredients, our quality controls and our bioequivalence studies.
Active pharmaceutical ingredients
Discover DENK PHARMA APIs – Active Pharmaceutical Ingredients – quality starts here
- All active pharmaceutical ingredients are identical to those used in the German market.
- DENK PHARMA APIs fulfill the quality specifications of the German Marketing Authorization.
- Suppliers are regularly assessed and audited by DENK PHARMA’s Quality Assurance.
Discover DENK PHARMA quality control – peace of mind for prescriber and patient
- Production-integrated computer systems guide, control and document every step of the production process operated by trained staff.
- Every finished product is manufactured and tested for compliance with relevant legal requirements (EU-GMP guidelines, Marketing Authorizations) and is released for sale by our Qualified Person.
- The specifications and test methods according Marketing Authorization comply with the requirements of the European Pharmacopoeia and USP (Amercian Pharmacopoeia).
- All tablets are additionally subjected to dissolution tests, to ensure perfect active ingredient absorption.
- Our laboratory is state-of-the-art. Over 25 HPLC units are available for analysis of the final products.
We attach importance to the quality of our product packaging. Our primary and secondary packaging complies with the highest standards to ensure the maximum stability and safety of the drug.
Stability & shelf-life
Discover DENK PHARMA stability & shelf-life
- Comprehensive stability studies, in line with ICH guidelines (Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), are available for all products.
- On-going stability studies are conducted on all products under normal and extreme climatic conditions to ensure quality until expiry date.
Discover DENK PHARMA transport excellence According to the European Good distribution practice (GDP) Guidelines, medicines have to be obtained from a licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the marketing authorization or product specification. We transport our high quality products worldwide via air, ship and road. Our products are delivered to different climate areas including high temperature and humidity. We ensure that our products are transported correctly, so that we always deliver best German quality. To make sure that the temperature stays within a certain range during transport, we use temperature logger. Our temperature logger is a portable measurement instrument to record the temperature during transport over a defined period of time of our products.
Pharmacovigilance (PV), also known as Drug Safety, aims to enhance patient care and patient safety in relation to use of medicines. According to the World Health Organization (WHO) PV is defined as the science and activities relating to:
- The detection,
- understanding &
- prevention of adverse effects or any other drug-related problem.
PV is a continuously risk-benefit monitoring and the initiation of necessary actions.
Denk Pharma has elaborated a pharmacovigilance system according to the current European guidelines GVP (good pharmacovigilance practices). Our activities include:
- Collection + evaluation of pharmacovigilance relevant cases
- Reporting of side effects and abuses (spontaneous cases + literature reports)
- Literature research
- Declaration of all product details to EMA authorities
- Issue of PSUR (periodic safety update report)
For Denk Pharma German quality and recall regulation are not just applied to Germany and Europe but worldwide!
- Continuously risk-benefit monitoring
- Prevention of side effects / interactions and other drug related problems
Our aim is to protect the health of our patients!