Services

What we do

Steiner Arzneimittel specialises in the production of medicines containing cephalosporins. Along with penicillin, cephalosporins are among the most commonly prescribed antibiotics in Germany and, despite the high demand, are still produced by only a few manufacturers in Europe – there are currently only two manufacturers left nationwide. The drug group offers a broad spectrum of efficacy against bacterial infections and is used in all age groups due to its good tolerability. 

Our portfolio includes film-coated tablets, hard capsules and dry juices. We produce for Aristo Pharma as well as for various third-party customers. Every year, 50 million tablets, six million folding boxes and 250,000 bottles of dry juice come off the production line. We produce different dosages depending on the application area and target market. 

To ensure the high quality of our medicines throughout all production steps, our laboratories are equipped for all essential analytical processes – the analytical services range from the development and validation of analytical methods, contract analysis, re-analysis of products manufactured outside the EU to the release of medicines for the European market.

Film-coated tablets

Tablet compression is one of the standards in drug production, but special expertise is required when handling the cephalosporins. 

In contrast to moist granulation, only dry granulation or direct compression can be used for processing cephalosporins. Due to the high dosage, however, direct compression is only possible under special circumstances. We produce 50 million tablets per year using both methods.

Hard capsules

Although the production of hard capsules is more demanding and cost-intensive compared to tablet production, it does have some advantages. For example, the sensitive active substance is better protected from external influences such as light. 

Steiner Arzneimittel uses roller compactors to produce the dry granulates required for capsule filling.

Our quality standards

At our site, only cephalosporins are processed into medicines, as required by law. Our quality control and management teams accompany antibiotic production from start to finish with pharmaceutical expertise to ensure consistently high-quality products. 

To optimise the qualification and validation of all processes, we have established a change control system. This enables us to implement all changes to our processes in a coordinated and regulated manner. In this way, we also comply with the guidelines of Good Manufacturing Practice. In addition to the prescribed inspections by the authorities, our cooperation partners also have access to our work processes in audits.

Dry juices

Juices are dosage forms that can be taken very well by children. However, cephalosporins in aqueous solution have a limited shelf life. This problem is solved by using dry juices. Here, only the active ingredient is filled into a bottle as a powder mixture. Before use, the user fills the bottle with drinking water up to the mark and shakes the resulting suspension. Depending on the product, this suspension can be used for up to 14 days.

We can fill up to three million bottles with dry juices. The dosing accuracy of the powder filling plays an essential role in the quality of the drug. Flow properties of the powder mixture as well as re-dispersibility receive special attention already during development and process transfer/scale-up.

Laboratory analyses

The high quality standards of our production facilities are also reflected in the area of our laboratory technology. Within the scope of product development and product transfer, the necessary methods of quality testing are established. We have all common testing equipment such as photometers, liquid and gas chromatographs with UV and diode array detection for content and purity analysis, testing equipment for physical investigations such as release apparatus, disintegration testers, hardness and abrasion testers.

Herewith we offer a full product support with process validations and stability tests.

Our Services

What we also offer

Our wide-ranging services are also available to other pharmaceutical companies. These range from all aspects of order processing to product development and analytical procedures.

Pilot batches and test samples

Within the framework of developments and product transfers, the production of pilot batches as well as process development and validation is an indispensable component. We also produce clinical investigational medicinal products on site that comply with EU GMP requirements.

Process optimisations

We constantly review formulations and manufacturing processes to increase our efficiency.

Packaging

Whether blistering, carton packaging or bottle line: Our packaging guarantees the safety and stability of the goods to be delivered.

contact

Are you looking for a contract manufacturer? Get in touch with us.

Do you have questions about our services, would you like advice or a quote? Then get in touch with us. We are available to you at any time by phone or email.