IOL Chemicals gets EDQM certification for API supply to Europe

IOL Chemicals and Pharmaceuticals on Monday said it has received certificate of suitability from EDQM to supply Pantoprazole Sodium Sesquihydrate API in European markets. The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a mandatory certification for distribution of any API/ pharma products in Europe.

Pantoprazole Sodium Sesquihydrate, an active pharmaceutical ingredient (API), is proton pump inhibitor used in drugs to suppress the gastric acid secretion.

"The company started production of Pantoprazole Sodium Sesquihydrate in Q3 FY 2020 at its Punjab-based facility.


"With this CEP (certificate of suitability) certification, the company will now be able to export it to entire Europe. IOL currently has a total capacity of producing 240 TPA of Pantoprazole Sodium Sesquihydrate," a release said.

IOL is the world's largest producer of Ibuprofen API with 33 per cent market share globally.

The company has 13 plus APIs in its portfolio such as Metformin Hydrochloride, Clopidogrel Bisulfate Form II, Fenofibrate, Paracetamol etc.

The European Medicines Agency (EMA) and EDQM cooperate on matters aimed at ensuring the quality of medicines and protection of public health in Europe.