Complete development of generic drugs

Finding the right molecule is not enough. You need to make it work for you. For that, you need to understand it. With us, you will know your formulation like you’ve grown up with it.

We will begin by reverse engineering the original product. Then, we develop our own prototypes and test them rigorously. To ensure that you have no problems producing it, we will help you optimise the manufacturing process. And, of course, we can do just a part of the whole process, or we can take care of the entire thing, end-to-end.

We have many years of experience with drug product development and more than 100 projects under our belt. We are able to combine our technical skills with specialised analytical equipment and project management skills.

We will help you find the right way to select the API, develop it into a useful dosage form, and fine-tune the manufacturing processes. We can also help with troubleshooting and problem analysis.

Synavia

Our client requested a reverse-engineering analysis of the reference product for the purpose of Scientific Advice discussion at an initial stage of development. The reference product consisted of 8 excipients, several of which had the contents indicated in the SmPC. The response from Kapaji was swift and very helpful. The analytical study was performed without delay and at a reasonable cost. It has given satisfactory results allowing for a complete picture of the quantitative composition of the reference product. Overall, Kapaji’s approach is prompt, scientifically professional, and, last but not least, friendly and enthusiastic.
Martina Nora Odložilíková — Independent Consultant

API solid form​

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Full experimental design for API solid form preparation and selection. Starting with small solid-state experiments and going all the way to the physico-chemical characterisation of new crystal or amorphous API forms. We can help you scale up processes to continue on an industrial scale.

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API characterisation​

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Standard and nonstandard experimental testing to fully characterise API. Different angles of API characterisation: in vitro testing, chemical degradation, and solid-state stability. We can also perform evaluations regarding molecular and powder properties.

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Intermediates

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The typical missing link in drug product development. In case of trouble, we step in and characterise the granules or pellets based on the project needs and identify critical quality attributes.

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Drug products

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Understanding the original or competitor’s product and uncovering the issues during drug development transfer or standard manufacturing? We can do it. Need to better understand the differences or similarities between the test and reference before clinical trials? No problem. We have extensive knowledge, experience, and state-of-the-art equipment to be the right partner for you.

Outsource your lab work

You can get results without having your own lab. Outsource your lab work to Labka, a development and manufacturing support provider. Acquire state-of-the-art equipment and facilities and order specialised analytical testing for API or drug product development support. Pick one of the available packages, or have the service custom-designed.
Labka
What else can we sort out for you?

Transfer →

With us, you will know your formulation like you’ve
grown up with it.