Suven Life Sciences, a Hyderabad-based biopharmaceutical company, has been granted the first Certificate of Suitability (CEP) by the European Directorate for the Quality of Medicines (EDQM) for its active pharmaceutical ingredient (API) product -- tamsulosin hydrocloride.
The CEP granted by the European Directorate, one of the major institutions involved in the regulation and quality control of medicinal products authorised for use in Europe, will simplify and makes easier the registration procedures of Suven's customers, the company stated in a press release on Monday.
The role of CEP is to certify the compliance of a material with the requirements laid down in the relevant monograph of the European Pharmacopoeia (EP). APIs for which CEP has been granted are suitable for use in medicinal products. The CEPs are recognised by the 36 member states of the European Union and additional countries like Australia, Canada and Switzerland.