‘Certificate of Suitability’ (CEP) approval for the manufacture of Ibuprofen API, from European Directorate for the Quality of Medicines (EDQM), was granted to Solara Active Pharma Sciences Limited (Solara), a leading pure play Active Pharmaceutical Ingredient provider, at its new state-of-the-art multipurpose API manufacturing facility in Vishakhapatnam, Andhra Pradesh. This is the first international regulatory approval for this new facility.
With this crucial certification, Solara now has CEP permission for two Ibuprofen API manufacturing plants, the other of which is a dedicated site in Puducherry, India.
For its Vizag facility, Solara also anticipates receiving a number of other foreign regulatory clearances, including the USFDA.