Solara Active Pharma shares gain 7% as CEP for Ranitidine Hydrochloride is restored by EU regulator
The share touched a 52-week high of Rs 1,859.30 and a 52-week low of Rs 622.20 on May 19, 2021 and July 16, 2020, respectively.
July 02, 2021 / 03:18 PM IST
Solara Active Pharma Sciences share price added over 7 percent intraday on July 2 after the European Directorate for the Quality of Medicines restored the certificate of suitability (CEP) for Ranitidine Hydrochloride drug substance.
"..... announce that the CEP for Ranitidine Hydrochloride drug substance (CEP 2001-228) has been restored by European Directorate for the Quality of Medicines (EDQM), company said in the release.
A revised CEP has been granted as of July 1, 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 data has fast-tracked the restoration of CEP by EDQM, it said. Solara is the only company among Ranitidine API manufacturers to have its CEP restored
Solara Active Pharma Sciences was quoting at Rs 1,715.10, up Rs 45.50, or 2.73 percent on the BSE.
The share touched a 52-week high of Rs 1,859.30 and a 52-week low of Rs 622.20 on May 19, 2021 and July 16, 2020, respectively. It is trading 7.76 percent below its 52-week high and 175.65 percent above its 52-week low.