Lysi Fish Oil API-grade

Natural Fish Oils Now available as API

(Active Pharmaceutical Ingredient)

For a number of years there has been an increasing demand for pharmaceutical grade fish oil and today some markets require fish oils to be registered as pharmaceuticals. In addition, there have been increasing demands for the quality standards of food supplement products. 

In order to meet customers' needs LYSI adapted its processes to the requirements of standards on good manufacturing practice (GMP) for active pharmaceutical ingredients (API). This work concluded with a GMP certification in 2007 issued by the Icelandic Medicines Agency.

LYSI is registered in the European Inspections database (EudraGMDP) as an approved API manufacturer. LYSI is approved as the manufacturer of APIs used in the production of licenced medicinal products by European authorities including the most recent British medicinal authority (MHRA). 

LYSI now offers its customers several fish oil products as active pharmaceutical ingredients applicable for use in medicinal products as well as in food supplements with higher quality standards. 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.

API grade oils at LYSI are based on corresponding monographs in the European Pharmacopoeia. As part of purchasing API grade fish oil from LYSI our customers will receive an Active Substance Master File required for registering medicinal products within the EU. Included are appropriate validations and stability data in accordance with ICH guidelines.

A comparative table can be found here below (Table 1) demonstrating some of the differences between LYSI food supplement products and API products. 

For customers who are interested in higher quality product and need for example to have access to detailed documentation such as stability data, validation data of analytical methods and or the manufacturing process, LYSI hf. recommends purchasing the available API products.

For further information please contact bulk@lysi.is who will be happy to answer any questions you may have.

Table 1 Comparison of food supplement products and API products