The drug maker announced that the Certificates of Suitability (CEP) for ranitidine hydrochloride drug substance (CEP 2001-228) has been restored by European Directorate for the Quality of Medicines & HealthCare (EDQM).
A revised CEP has been granted as of 1 July 2021. Ranitidine hydrochloride was an important product for Solara and was manufactured at its Cuddalore site in Tamil Nadu.Solara said it 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.
Solara Active Pharma Sciences offers a basket of diversified, high-value commercial APIs and contract manufacturing services in over 75 countries. On a consolidated basis, the company posted a 217.9% jump in net profit to Rs 56.61 crore on a 49.7% rise in net sales to Rs 444.21 crore in Q4 FY21 over Q4 FY20.
Shares of Solara Active Pharma Sciences gained 2.82% to Rs 1,716.65. The stock hit a high of Rs 1795.15 and a low of Rs 1684.75 so far during the day.
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