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  1. Novo Nordisk Pharmatech
4 December 2020

From Denmark to Your Lab – the Journey of our Insulin Human AF

Did you know that our Insulin Human AF is the same high-quality insulin supplied to patients all around the world for therapeutic use? It’s produced by our parent company Novo Nordisk, the world’s largest producer of insulin, in Kalundborg, Denmark. Spread across 1.2 million square metres with a 3,000-person workforce, this site manufactures around half of the world’s insulin. The fully cGMP certified facilities and ISO 9001 quality system ensure the highest standards of quality, consistency and purity

Filled in classified room facilities

From Kalundborg, the Insulin Human AF comes to our site in Køge to be filled in sizes ranging from 1g to 1kg, depending on your needs. Our classified room facilities were purpose-built to ensure the purity of the Insulin Human AF and keep it at the correct temperature. Based on stability data, we know that Insulin Human AF can be stored at refrigerator temperature (+2 to +8°C) for up to 14 days in total, accumulated over its shelf life period and 5 years at -20°C ± 5°C. In connection with dispensing the product, keeping and handling the product at up to 25°C is allowed for up to 24 hours. But we give ourselves just a few hours to perform the process so that you benefit from longer shelf life and more flexibility. That’s also why we ship in dry ice containers.

Getting the insulin safely to your lab

The HDPE plastic containers are placed in individual tamper-proof plastic bags. The tamper-proof containers are then placed in approved thermo containers inside a cardboard box. We add enough dry ice to make sure that the product is kept below the recommended maximum temperature (-20°C ± 5°C) during shipping. We created the shipping material specifically for our shipment boxes, complete with validity studies. We are so confident in this method that we do not have a requalification process; if the product is not delivered, or re-icing is not performed, the product is simply scrapped.

Available wherever, whenever you need it

Our two locally placed distribution centres – near Copenhagen, Denmark, and in Indiana, USA – ensure short lead-times worldwide. We are also a certified Known Consignor. We have enough packed off-the-shelf Insulin Human AF in stock for at least five months of consumption, so we are able to respond immediately to your specific requirements.

For more information regarding Recombinant Human Insulin AF, please contact Senior Sales Manager Timur Özbay at tozy@novonordisk.com.

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