Active pharmaceutical ingredients for clinical samples
HAPILA GmbH is a company with many years of tradition in the synthesis and development of active ingredients. We have accompanied our partners from the idea on paper to clinical phase III for almost two decades. Some of our long-standing business partners still supply the market with medicines made from HAPILA active ingredients.
Due to the diversity of the active ingredient classes and their applications and formulations, we offer you in-depth and reliable knowledge in the development of chemical active ingredient syntheses and versatile methods for isolating and purifying synthetic products. Both the high product quality and the economic efficiency of the process form integral parts of our work, so that the title “Made in Germany” remains affordable to this day. Some of our processes are so innovative that they have even been patented (HAPIpur®) which we are particularly proud of.
By choosing HAPILA GmbH, you enjoy all the advantages of a local manufacturer of active pharmaceutical ingredients with the highest quality standards and short supply chains. Since we offer all the steps of the API presentation as one-stop-shop solution, you have minimal administrative effort and a personal contact who accompanies and advises you on the way from the idea to the product. Through the intensive exchange of information with our customers in the form of reports and video calls or face-to-face meetings, you are informed about every step in the milestone program and our processes are designed to be as transparent as possible for you.
We create your active ingredient sample for use in clinical trials in accordance with the EU GMP Guide Part 2 – Section 19 according to your individual needs.
An excerpt from our portfolio:
- development of a scalable synthesis and analytical methods
- improvement and development of methods for the isolation and purification of synthesis products
- establishing the release specifications for starting materials, intermediate and end products
- determination of storage, packaging and transport conditions (GDP)
- GMP-compliant documentation
- particle design (including micronization)
- analysis and certified release of active ingredient samples for use as pharmaceutical raw materials (human or veterinary)
- Support and coordination of the creation of regulatory documents for the submission process (e.g.: IMPD)
We would like to explore the options together with you in a personal conversation.
Additionally, we are also happy to be at your disposal as a partner for the production of active ingredients for (human or veterinary) clinical studies and take care of the necessary regulatory documents.
If you wish, we can also accompany you in the development of the active substance and support you in the creation and revision of the documents required for the IMPD
Contact Person: Dr Uwe Müller
