Solara Active Pharma Sciences said that its certificates of suitability (CEP) for Ranitidine Hydrochloride drug substance (CEP 2001-228) has been restored by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

The API manufacturer said that the revised CEP was issued as of 1 July 2021. Ranitidine Hydrochloride is said to have been a major product for Solara Active Pharma Sciences and was manufactured at its facility in Cuddalore in Tamil Nadu, India.

Solara Active Pharma Sciences claimed that it has strong manufacturing and quality processes in place at the facility to mitigate the risks of N-Nitroso Dimethylamine (NDMA) formation in the Ranitidine HCL API.

The API manufacturer said that subsequent submission of the relevant data had expedited the restoration of CEP by EDQM. Currently, Solara Active Pharma Sciences is said to be the only company among manufacturers of Ranitidine API to have its CEP restored.

  EDQM, India, Ranitidine Hydrochloride, Solara Active Pharma Sciences, Tamil Nadu