Codeine (Phosphate Hemihydrate)

Dolder announces the grant of a CEP by EDQM for Toprak Mahsulleri Ofisi (T.M.O.)

Dolder has been granted a CEP for Codeine Phosphate Hemihydrate (R0-CEP 2005-297-Rev 00) from the Turkish pharmaceutical manufacturing firm Toprak Mahsulleri Ofisi Genel Mudurlugu (T.M.O.) in August 2009 by the EDQM. The CEP for Codeine (R0-CEP 2005-296-Rev 00) has been already received in May 2009.

In 2004 an exclusive agreement for mutual cooperation to elaborate an ASMF dossier was agreed between Dolder and T.M.O. The cooperation between the CEP holder T.M.O. and Dolder has been developed over several generations and these two CEP are regarded as highlights for this established partnership and collaboration.

Your benefits
T.M.O. is regularly audited by Dolder and will place the marketing and distribution of codeine and codeine phosphate hemihydrate in the hands of Dolder. Dolder is proud to be the technical support and regulatory affairs partner in the successful registration of this antitussive. As a result, finished product manufacturers finally gain access to a competitively priced alternative to established providers.

The product
Codeine, a phenanthrene derivative, is an opioid analgesic obtained from opium or made by methylating morphine. It is a much less potent analgesic than morphine and has relatively mild sedative effects. Codeine, especially its phosphate salt, is given orally in the form of linctuses for the relief of coughs and as tablets for the relief of mild to moderate pain, often in combination with a non-opioid analgesic such as aspirin, ibuprofen or paracetamol. The phosphate is also administered by intramuscular or subcutaneous injection for the relief of pain. Please refer to our Fact Sheets for Codeine and Codeine Phosphate (PDF) for details.