Maxomega Secures Accreditation for Japan
The Japanese pharmaceutical market is the second largest individual market after the US. Its annual sales of some $60 billion constitute approximately 11% of the world market. Equateq’s proprietorial Maxomega technology allows it to deliver the highest concentration levels possible in the sector, at up to 99% purity of a single lipid. The facility has been a site of lipid concentration for nearly 30 years, and is certified as cGMP by the UK’s health authority, the MHRA.
1/24/20011- Pharmaceutical Lipid Manufacturer Equateq has secured a manufacturer’s accreditation for Japan, taking the company a step closer to offering its Maxomega super-pure omega oil concentrates in the world’s second largest pharmaceutical market.
Japan’s Ministry of Health, Labour and Welfare issued the Accreditation certification (AG20500095) for a Foreign Drug Manufacturer (FMA) in the category of non-sterile drugs. The application included a full review of Equateq’s cGMP manufacturing facility in the Western Isles of Scotland, and its ability to deliver pharmaceutical products in Japan in compliance with all relevant regulations.
Equateq made the application based on two Maxomega concentrates. The first is EPA97 ethyl ester, a specification well-established in Japan for treatment of hypertriglyceridemia. The second is a specific omega oil blend of both EPA and DHA.
‘This takes us one step closer to entering the Japanese market, where we have found there is considerable interest in the quality and price point of our omega APIs’ said Equateq CEO Adam Kelliher. ‘Japan is renowned as a world leader for its exacting standards of purity and consistency in API manufacturing, and so we are pleased to be able to comply with their requirements.’
The Japanese pharmaceutical market is the second largest individual market after the US. Its annual sales of some $60 billion constitute approximately 11% of the world market. Equateq’s proprietorial Maxomega technology allows it to deliver the highest concentration levels possible in the sector, at up to 99% purity of a single lipid. The facility has been a site of lipid concentration for nearly 30 years, and is certified as cGMP by the UK’s health authority, the MHRA.
