Rottendorf Pharma - Manufacture and Development of Solid Dosage Forms

Rottendorf Pharma is one of Europe’s leading contract manufacturers for solid dosage forms, with two plants in Germany and one in France. Our service range covers product development, galenical process development, analytical process development, production and packaging.

FLUID-BED GRANULATION

Rottendorf Pharma’s standard granulation technologies are fluid-bed granulation with Glatt GPCG (with capacities of 100kg to 300kg) and fluid-bed granulation with Diosna granulators (with capacities of 5kg to 250kg). These procedures are carried out in an explosion-protected granulation area.

We also use Gerteis compactors for dry granulation.

TABLETTING

We offer a substantial tabletting capacity on computer-controlled high-speed rotary presses, placed in 20 separate cabins.

We develop and produce multi-layered tablets, film-coated tablets, sugar-coated tablets, pellets and hard gelatine capsules. Due to the large variety of products, more than 400 tabletting tools (Euro B or Euro D) are in stock.

FILM-COATED TABLETS

We work with aqueous solutions as well as organic solvents, with capacities of 70kg to 700kg. There is also the possibility of manufacturing small-scale to minimum-sized batches in vessels according to the conventional top-spray procedure.

SUGAR-COATED TABLETS

Based on the model of manual sugar-coating vessels, Rottendorf Pharma has developed coating facilities that can be adjusted to the customer-specific manufacturing procedures via variable process parameters. This offers the combination of automatic and manual operating steps.

All vessels can be fed with varying suspensions. Lot sizes between 30kg and 300kg are possible, as well as sugar-coating batch sizes of up to 1,000kg.

PELLETS

For pellet production we use a Nicatrain E220 extruder, which is connected to a Nicatrain S700 spheronizer. The pellet coating is performed in a Wurster system from Aeromatic ( Precision Coater MP 4/5) and we are able to use aqueous and/or organic solutions.

CAPSULE FILLING

Rottendorf Pharma fills hard gelatine capsules with the Bosch GKF 1400 and GKF 400. The subsequent dedusting and 100% single-weight checks are also part of our standard range of operations.

HIGH-POTENCY PRODUCTS

We manufacture products with highly potent active substances, such as Tamoxifen, Flutamid and Clomifen, in a separate production area. Further products with comparable active substances are also being developed.

This separate production area is equipped with separate entrances, a separate ventilation system (100% inlet air and outlet air), personnel locks and a laboratory.

QUALITY CONTROL

We carry out established routine analyses with the most advanced analytical equipment and according to the latest methods such as HPLC, quantitative DC, NIR, gas chromatography, ICP, etc. However, we also have a separate laboratory for vitamins and mineral compound analyses, raw materials and finished medicinal product analysis.

Long-term stability follow-up programmes, according to ICH, as well as the development and validation of analytical methods are offered separately.

PACKAGING

We can offer our customers a wide variety of differing technologies relating to bulk production at our plant or single services. These technologies include:

• Blistering - PVC/PVDC, triplex, Aclar, aluminium-aluminium
• Plastic container and bottle filling
• Filling granular material into bottles
• Sealed sachets (aluminium strips)
• Sachet-filling (powder and granules).

ADDITIONAL CONTRACT MANUFACTURING SERVICES

We also offer other contract manufacturing services, including:

• Sourcing
• Product development
• Galenical process development
• Analytical process development
• Production
• Production of high-potency products
• Analytics
• Process validation and analytical method validation
• Stability testing
• Packaging
• Manual and special packaging
• Negotiating approved product registrations

Being exclusively a contract manufacturer, Rottendorf Pharma is a customer-orientated and reliable partner for your solid dosage forms.