News
LYSI OFFERS NATURAL FISH OILS AS ACTIVE PHARMACEUTICAL INGREDIENTS
11.11.2015
For a number of years LYSI has sold its fish oil products to several pharmaceutical companies. Those companies have used LYSI's products in creating their own products, either directly or as an ingredient. In some cases such new products have been characterised and registered as medicinal products.
In order to meet customers' needs LYSI adapted its processes to the requirements of standards on good manufacturing practice for active pharmaceutical ingredients. This work concluded with GMP certification in 2007.
However, the GMP certification was not the end of the matter. At the request of a customer LYSI started preparations in 2013 for the production of registered active pharmaceutical ingredients for registered medicinal products. LYSI recruited people with expert knowledge in the field and invested in the required equipment.
In September 2014, after passing an audit conducted by the Icelandic Medicines Agency, LYSI was registered in the European Inspections database as an approved API manufacturer. In May 2015 LYSI was approved by the British Medicines & Healthcare products Regulatory Agency (MHRA) as the manufacturer of APIs used in the production of two licenced medicinal products.
LYSI can now offer its customers several fish oil products as active pharmaceutical ingredients. With the expertise and experience gained from registration of API products LYSI also offers its customers assistance in registering their own products.
Offering natural fish oils as active pharmaceutical ingredients has placed LYSI in a unique position in its market.