The Medreich way to XL
IXL - Innovative Excellence Centre, Medreich
IXL was commissioned to design and develop innovative oral dosage forms for Medreich's own marketing as well as for third party development contracts.
New drug delivery systems are regarded to be a major co-opportunity for the team, especially if suitable platform technologies can be developed. Capability exists to handle rapidly dissolving tablets, chewable tablets, melt in the mouth crystals, soft-lets and sustained release tablets.
During the last few years, IXL has delivered many products to diverse cross section of customers. The revenue stream generated from this group has encouraged the company to make further investment to make this Centre of Excellence an integrated unit from concept right the way through to manufacturing validation batches. This will enable the group to enhance substantially its output besides coping with time schedules.
Medreich expects this group to be a contributor to its earnings in the coming years besides building an Intellectual Property repository for the company.
RXL - Regulatory Excellence Centre
This group handles the regulatory documentation for the Group. Teams are divided by region. Dedicated teams exist for handling the CTD dossier format for Europe. Other teams handle dossiers for the developing markets and another handles the regulatory requirements of our Strategic Alliance partners who have outsourced manufacturing to Medreich.
Medreich is in the process of filing its own registrations based on its own formulae in Europe. The first dozen applications are already in the approval process in Europe with agencies such as MHRA. Having achieved this, Medreich is now fully conversant with the requirements and underlying thinking behind the Common Technical Registration Document in Europe therefore will pursue this route to proliferate registrations across EU.
Medreich is in the process of acquiring skills and knowledge base now to extend its regulatory filing in the United States of America. Medreich's first ANDA filing is not far away.
|