From active substance to application
Our Raw Materials Help Patients
Pharmaceutical substances, also termed APIs (Active Pharmaceutical Ingredients), are the raw materials for the production of commercial drugs, and are counted among the most heavily regulated substance. In addition to APIs, the manufacture of drugs also requires excipients. The class of compounds comprises carriers such as lactose, as well as other additives. Although less regulated than APIs, excipients are subject to increasingly strict control.
Whether cancer medication, highly potent rheumatism ointments or Aspirin – the one thing all commercial drugs have in common is the presence of one or more active substances that cure diseases, alleviate symptoms or suppress pain.
There are many bulk producers of common APIs. However, manufacturers of small quantities of APIs or rare substances are difficult to find. The Cfm Oskar Tropitzsch GmbH can draw on a worldwide network of experts and specialized manufacturers, as well as the knowledge necessary to find the right partner for you to support you in the production of new active substances.
Success requires perseverance
We remain at our customer's side
“The files that document the beginnings of this project still are on my shelf within my sight,” Michael Schäffler says about a contract that required perseverance, prudent action, as well as a knack for communication.
In 2006, the newly appointed CEO of a German pharma company approached us with the question whether we were able to act as the second source for the active substance of an analgesic ointment. We located a reliable producer in our database.
The signing of non-disclosure agreements was followed by an extensive exchange of specifications and further documents that were subjected to thorough review by both parties. A few months later, the first samples were sent, tested and approved. Based on these initial results, our customer initiated further steps: the planning and scheduling of audits, the ordering of validation batches, the production of test batches, the filing of application for amendment with the authorities, the implementation of stability studies, to name just a few.
For the duration of the whole process which took almost two years, Cfm as well as our supplier offered constant advice and support to our customer. The resulting contract negotiations were only made possible by the focus of all parties on the main goal of a long-term cooperation.
After almost five years of intense work, both sides were finally able to celebrate the successful conclusion of the contract. Owing to the excellent cooperation of all involved parties, this was the beginning of a fruitful and long-ranging partnership.
The foresight of our customer’s CEO in establishing a reliable second source supplier was rewarded when the former main supplier discontinued production of the active substance in question. Ten years after our cooperation on this project began, Cfm took over the responsibility as main supplier, and to this day reliably supplies the material in question on time and in the required quantities. Our continual efforts including numerous business trips, meetings, negotiations, the delivery of samples and the registration of the API in several countries resulted in an annual delivery of 20 megatons of this material to our customer.
This is what we mean by „Finding the best solution for you!“