Solara Active Pharma Sciences has received European Approval (CEP) to manufacture Ibuprofen from its flagship Vizag facility. The pure-play active pharmaceutical ingredient provider announced that its new multipurpose API manufacturing facility at Vishakhapatnam, Andhra Pradesh, received 'Certificate of Suitability' (CEP) approval for the manufacture of Ibuprofen API, from the European Directorate for the Quality of Medicines (EDQM), the first international regulatory approval for this new facility.
With this key approval, Solara has CEP approval for two manufacturing facilities for Ibuprofen API, the other being its dedicated manufacturing facility located at Puducherry.
Solara also expects a series of other international regulatory approvals for its Vizag facility, including the US Food and Drug Administration (US FDA).
Solara Active Pharma Sciences is a pure-play global API manufacturer supported by R&D and manufacturing facilities. With six manufacturing facilities and an R&D centre, Solara offers a basket of diversified, high-value Commercial APIs and Contract manufacturing services. Its API facilities are approved by various international regulatory agencies including the USFDA, EDQM, MFDS, WHO, PMDA etc.
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