Chanelle Medical - Pharmaceutical Contract Manufacturing and Packaging, and Generic Product Development

As one of the leaders in generic drug development and contract manufacturing in Europe Chanelle Medical’s advanced contract manufacturing operation provides quality products to pharmaceutical companies worldwide. Our state-of-the-art production facility has a highly skilled workforce of over 250 employees and offers the capacity to manufacture up to two billion tablets and three billion capsules per annum.

Licensed by the Irish Medicines Board (IMB) as a manufacturer of human medicines, Chanelle Medical is also registered to the internationally recognised Quality Standard ISO 9001:2000. Furthermore, as a result of customer audits we are an approved supplier to many major international pharmaceutical companies.

PHARMACEUTICAL CONTRACT MANUFACTURING

In addition to manufacturing our own developed products, Chanelle Medical offers pharmaceutical contract manufacturing of solid dosage forms, liquids and powders. Quantities range from lab scale to pilot plant stage through to commercial production.

Our pharmaceutical contract manufacturing capabilities include tablets, capsules, liquids, powders and granules, which are packaged, stored, batch released and distributed to five continents worldwide, using the expertise of our five qualified persons on site. We also have the ability to handle controlled drugs.

Our contract manufacturing equipment is in environmentally controlled areas and includes:

• Granulation – Diosna; drying – Glatt fluid bed dryer; compression – two Fettes; encapsulation – Macofar and Pam; tablet coating (film coated, enteric coated, sugar coated) – Ganson and Sejong; printing – Markem; two 10,000L vessels; one 2,000L vessel
• Separate development scale equipment matching the above, including aeromatic PMA65 mixer granulators and Aeromatic MP2 fluid bed dryers

PHARMACEUTICAL CONTRACT PACKAGING

We offer a wide choice of pharmaceutical contract packaging options for all solid dose, liquid and powder forms. Our equipment is carefully chosen and means we can provide an efficient, fast and cost-effective pharmaceutical packaging solution whatever the size of the batch.

Our blister packaging equipment allows us to produce presentations with PVC PVC / PVDC, Aclar as well as cold form Alu / Alu. All our automated pharmaceutical packaging lines incorporate GMP security / control devices thereby ensuring that the correct components are present in each pack. Similarly, by employing 100% check weighing, the correct quantity per pack is assured. All our packaging lines are in dedicated environmentally controlled areas.

Our contract packaging equipment includes:

• One Uhlmann UPS600 fully integrated blister packing line, capable of producing cold form Alu / Alu, Aclar, PVC PVC/PVDC packs
• Three Noack 623 fully integrated blister packing lines, capable of producing cold form Alu/Alu, Aclar, PVC PVC/PVDC packs
• Two Noack 760 fully integrated blister packing lines, capable of producing cold form Alu/Alu, Aclar, PVC PVC/PVDC packs
• One Volpak automatic sachet filling line, capable of producing simplex and duplex sachets
• One Countec tablet counter bottle filling line, comprising unscrambler, twin headed filler, capper, labeler, cartonner, vignette applicator and check weigher

We operate a cGMP temperature-controlled warehouse.

R&D, REGISTRATION AND LICENSING

Chanelle Medical offers a full range of services in generic registration and development, combined with a dedicated launch team. We are well equipped to ensure your product hits the shelves immediately following patent expiry. Our full range of services means that we can offer you a complete development package to meet the requirements of the generic industry.

GENERIC PRODUCT DEVELOPMENT

Our generic product development capabilities include:

• Formulation development: solutions, suspensions, powders, tablets and capsules including slow release formulations
• Analytical method development
• Analytical method validation
• Process validation: pilot and commercial scale batches
• Stability studies according to ICH guidelines
• Monitoring of bioequivalence studies according to GCP

MARKETING AUTHORISATION AND REGULATORY SERVICES

We can offer services including:

• Compiling of EU dossier
• Submission to health authorities
• Tracking of subsequent regulatory process
• Support during the registration process and responding to questions issued by authorities
• Conducting mutual recognition procedures
• Post-registration support for dossier maintenance and the preparation of variation applications as needed

PRODUCT DELIVERY

We provide a reliable product delivery service including product launch after patent expiry and long term supply of products

Our services are backed by a highly committed and experienced regulatory team with an extensive and diverse background in the pharmaceutical industry. Our first rate registration files and our competent regulatory support enables you to successfully register our products in your markets.

ANALYTICAL SERVICES

Chanelle Medical’s expertise in analytical services is widely recognised. Customers are offered a wide range of services including:

• Analytical method transfer
• Analytical method validation
• Qualitative ID testing
• In-process testing
• Product release testing
• Process validation testing
• Stability testing as per ICH guidelines
• Q.P. release

The facility has its own dedicated laboratory with analysts skilled in both analytical method development and routine testing. The laboratory has state of the art equipment with over 28 HPLC’s (Waters linked to Millennium software), dissolution baths, infrared and UV spectrophotometry.