Mumbai, India-based Elder announced the CEP on the Bombay Stock Exchange last week . Diosmin is an oral phlebotropic approved to treat chronic venous insufficiency (CVI) and haemorrhoides in Europe, while in the US it is sold as a nutritional supplement.
Elder managing director Alok Saxena told the Economic Times the firm has “customers throughout the world including Southeast Asia, Africa and Latin American region. COS approval for Diosmin will enable the doors of the European region to open up for Elder, thus enabling the company to expand its global market share.”
He also estimated that the global Diosmin market is worth around $500m (€394m) a year with some $255m of those sales coming from Europe.
At present only two European manufacturers have CEPs for the active pharmaceutical ingredient, Spain’s Faes Farma and French’s Isochem. – with the only other EDQM certification being held by Shaanxi Huifeng Pharmaceutical.
As European sales seem to be Elder’s primary objective now it has the CEP it is likely that the firm's Bulgarian subsidiary Elder Biomeda AD – a specialist in the importation and distribution of APIs that it acquired in 2000 – will play a key part in the efforts.
One factor the Indian firm will have to keep in mind is the new European Union (EU) API import laws that come into effect next year and will mean that – if it does make Diosmin in India – it will have to provide written proof it is produced to GMP or equivalent standards.
Note: CEP’s - which are also sometimes unofficially (but understandably) referred to as COS’ – attest that a material is in compliance with the requirements laid down in the relevant monograph of the European Pharmacopoeia.