Delorbis Pharmaceuticals LTD

Contract Manufacturing

DELORBIS provides contract manufacturing for many customers.

This includes the entire technology transfer of our customers’ products to our manufacturing facilities, in accordance to their dossier requirements.

We also offer services such as EU batch testing and release of pharmaceutical products.

At DELORBIS, we are equipped with stability chambers that enable us to conduct ICH stability studies at long-term, intermediate and accelerated conditions.

In addition, DELORBIS offers many analytical testing services in compliance with GMP requirements and in accordance with the corresponding pharmacopeia (Eur. Ph., USP).

We can also provide regulatory assistance for the preparation of regulatory dossier documentation.

DELORBIS manufacturing facilities have been designed to accommodate the production and packaging operations of non-sterile oral solid dosage forms (tablets, capsules and powder suspensions for reconstitution). Our manufacturing site has been constructed to the strictest specifications and in accordance with the principles of current Good Manufacturing Practice as required by the guidelines of the European Union:

• Fully computerised Building Management System continuously monitors and controls our production environment (temperature, relative humidity, differential of pressure and air change per hour)
• Production and packing areas which are adequately segregated with independent material and personnel flows; these areas have been built to the highest standards using high end pharmaceutical panels and PVC floorings