By EDQM
Solara Active Pharma Sciences announced that the CEP for Ranitidine Hydrochloride drug substance (CEP 2001-228) has been restored by EDQM. A revised CEP has been granted as of 01 July 2021. Ranitidine Hydrochloride was an important product for Solara and was manufactured at its Cuddalore site.Solara had put in place robust manufacturing and quality processes to mitigate the risks of N-Nitroso Dimethylamine (NDMA) formation in the Ranitidine HCL API. Subsequent submission of the pertinent data has fast-tracked the restoration of CEP by EDQM. Solara is currently the only company among Ranitidine API manufacturers to have its CEP restored.
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