Solara Pharma’s manufacturing site garners positive FDA review

Solara Pharma’s manufacturing site garners positive FDA review

Solara Active Pharma Sciences Ltd’s (Solara Pharma) manufacturing facility in Cuddalore has garnered approval from the US Food and Drug Administration (US FDA). Following an inspection from July 31 to August 4, 2023, the facility received a green signal, indicating its “Acceptable State of Compliance” without any Form 483 observations from the US FDA. Enhanced […]

Solara Active Pharma gets CEP of Ranitidine API restored by EDQM

Solara Active Pharma gets CEP of Ranitidine API restored by EDQM

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 […]