Croda Health Care gets MHRA accreditation to produce omega-3 APIs
Croda Health Care's speciality lipid facility at Leek in Staffordshire, UK has achieved Medicines and Healthcare products Regulatory Agency (MHRA) approval for the manufacture omega-3 and omega-6 oils purified from crude marine and vegetable oils to be used as APIs.
The certificate of GMP compliance obtained ensures that the pharmaceutical industry can use the OmeRX range of lipid concentrates as Active Pharmaceutical Ingredients.
Paul Kollesoff, marketing manager said: "As market knowledge of the clinical benefits of Omega-3 and Omega-6 lipids is ever increasing, having MHRA approval to manufacture lipid APIs provides the pharmaceutical industry with the opportunity to utilise these fantastic materials in disease therapy."
OmeRX products are manufactured to the standards defined in ICHQ7A, annex 18 and give industry the opportunity to develop individual omega-3 actives to effectively target today's health issues.
The company has recently launched a new marine omega-3 concentrate, called Incromega Trio. Derived from food grade Salmon oil, the product is the first of its kind offering this combination of all three key fatty acids high levels of the fatty acids responsible for effective cardiovascular function - EPA (eicosapentaenoic acid), DPA (docosapentaenoic acid) and DHA (docosahexaenoic acid).
Dr Miquel Mir, product applications manager, said: "EPA and DHA have been used as dietary supplements to assist cardiovascular function for many years, however the role and benefit of DPA has been wholly underrated. EPA, DPA and DHA all have distinct but quite different benefits, introducing the three together in one potent, pharmaceutical grade marine oil offers a unique solution for the cardiovascular problems of today"
The new product is available in triglyceride or ethyl ester form and is manufactured using PureMax, Croda's proprietary concentration and purification technology which removes environmental contaminants such as dioxins, furans and PCBs
Other ingredients offered by Croda's health care division include essential fatty acids, high purity lipids, drug delivery systems and protein derivatives.