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Kallik

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A Rules Based Approach to Labelling and Artwork Management

Many organisations today are experiencing unprecedented demands from regulatory authorities and consumers alike for product labelling to be made clearer and more informative. Forthcoming regulations (including the new EU MDR regulations coming into force May 2020) also require that labelling content to be published electronically in addition to print. As companies seek to continuously differentiate themselves in established markets as well as gain entry into new territories, the increase in both volume and complexity of product and market variations will have a direct impact on labelling.
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News and Press Releases

A new market reference added to Safe’n’Sound®, our passive safety device platform

Safe’n’Sound® is on the market in Europe with a newly registered injectable medication. The commercial launch of HULIO™ (Adalimumab Biosimilar) was initiated in selected European markets on October 19,2018. Hulio™, developed by Fujifilm Kyowa Kirin Biologics Co., Ltd. and marketed in the European Union by Mylan N.V. is approved as a biosimilar for the same indications as the reference product, Humira®.
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White Papers

Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery

Presspart Manufacturing Ltd

Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains.
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Industry Events

Evolution Summit

4-7 May 2020, The Ritz Carlton, Fort Lauderdale, FL

The 22nd Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development.
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