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Pharmaceutical development
In the development of formulations with generic active ingredients or new chemical entities (NCEs), our long-term experience in developing solid, semi-solid and liquid medicinal products guarantees high-quality bulk products for further processing, e.g. for clinical studies or for the transfer to production scale. During the past decades, our company has shown a highly successful track record of realising numerous projects in the area of generic and over-the-counter products, as well as new chemical entities (NCEs).
Temmler has thorough knowledge of pharmaceutical dosage form design and processing, not only in the development of tablets, film-coated tablets etc. but also in pellet manufacturing. Three different pellet manufacturing methods have been established and are available from the development phase to the final production scale:
The development of semi-solid pharmaceutical dosage forms is implemented in close connection with and by using available manufacturing technologies and resources in GMP hygiene. Since the Feldkirchen production site gained FDA approval, Temmler is also in a position to develop and produce stability and bulk batches for the manufacture of investigational medicinal products according to FDA guidelines.
We will of course provide the required analytical support during the galenic development phase of a dosage form. We are also able to offer you complete development and validation services (in accordance with ICH guidelines) for the analytical processes, and the planning and implementation of stability tests according to ICH guidelines. For this purpose, we have climate chambers with the following storage conditions at our disposal:
Our fully equipped quality control units ensure that you will receive the required analytical support up to the approval testing of your GMP batches for all other development processes described herein.
Temmler has thorough knowledge of pharmaceutical dosage form design and processing, not only in the development of tablets, film-coated tablets etc. but also in pellet manufacturing. Three different pellet manufacturing methods have been established and are available from the development phase to the final production scale:
- Fluidized bed production by means of "suspension layering"
- A special granulation method with which high active ingredient concentrations can be realised
- Layer composition via a sugar core to realise special release profiles ("powder layering")
The development of semi-solid pharmaceutical dosage forms is implemented in close connection with and by using available manufacturing technologies and resources in GMP hygiene. Since the Feldkirchen production site gained FDA approval, Temmler is also in a position to develop and produce stability and bulk batches for the manufacture of investigational medicinal products according to FDA guidelines.
We will of course provide the required analytical support during the galenic development phase of a dosage form. We are also able to offer you complete development and validation services (in accordance with ICH guidelines) for the analytical processes, and the planning and implementation of stability tests according to ICH guidelines. For this purpose, we have climate chambers with the following storage conditions at our disposal:
- 25°C, 60% r.F.
- 30°C, 65% r.F.
- 40°C, 75% r.F.
Our fully equipped quality control units ensure that you will receive the required analytical support up to the approval testing of your GMP batches for all other development processes described herein.
Your Point of Contact
Customer Management
Customer Management
Telephone & Facsimile
+49 6421 / 494-494
+49 6421 / 494-200 (Fax)
info@temmler.eu
