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Pharmaceutical Product Development

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Alkalon

Bo Tandrup Founder & Chief Executive Officer

Alkalon is a remarkable little company. We have somehow managed to build up an amazing group of individuals working together as a team, a team characterised by a strong will to solve problems and make things work.

Alkalon is an independent, privately-owned contract research and product development company based in Denmark.

The company specialises in the development of medicated chewing gum formulations and is working in partnership with pharmaceutical companies on dosage form development projects and the supply of finished products.

Alkalon’s in-house R&D activities take place in a small non-GMP laboratory and all non-core activities are outsourced.

The company has recently developed and registered a portfolio of new, improved nicotine polacrilex chewing gum for the generics industry in Europe and elsewhere.

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· 2 and 4 mg nicotine

· Mint and fruit flavours

· Super crunchy maltitol coating

· Generic to Nicorette® nicotine gum

· Various secondary packaging options

Nicotine Chewing Gum

Global PresenceAlkalon’s products are in-licensed and marketed by generic companies all over the world. The top 3 markets are Western Europe, Australasia and Japan.

Alkalon is the first company to offer top quality generic nicotine gums.

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Alkalon has quality dossiers available for in-licensing and offers to supply the finished products packed and ready for sale.

We work in partnership with pharmaceutical companies all over the world and are known to be flexible when we negotiate License and Supply terms.

· Stability: 24/36 months including climatic zone 4

· Clinical: BE study shows equivalence to originator (Nicorette® nicotine gum)

· Freedom to operate report available

· On-line dossier review

· Approved in the EU and elsewhere

License and Supply – one partner

e-CTD Dossier

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We work in close collaboration with the industry’s most experienced researchers in the development of medicated chewing gum formulations. By working with us, you get access to this strong network of experts.

Alkalon offers to prepare prototypes and a technical report which will give you valuable information about the properties, release and stability of your drug substance in a medicated chewing gum formulation.

The price for a report and prototypes can be as low as €20,000. And we can do it in a few weeks.

Contract developmentTest your product– in a medicated chewing gum formulation

We usually perform release testing by in vitro dissolution, using a Ph.Eur chewing gum dissolution apparatus. Stress tests and initial stability studies are initiated as soon as samples are ready to allow quick optimisation of formulation parameters (choice of gum base, bulk sugars, coating excipient, etc.).

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Alkalon A/S is owned by a syndicate of venture capital companies and private investors. The largest investor controlling 45% of the shares is SEED Capital Denmark K/S.

Ownership

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www.alkalon.com · +45 38 86 84 82 · office@alkalon.com

Alkalon A/SCopenhagen Europe CentreVesterbrogade 149DK-1620 CopenhagenDENMARK

R&D LaboratoriesAlkalon A/SHåndværkervej 2DK-7120 Vejle DENMARK