The United States Food and Drug Administration (USFDA) has concluded an inspection at Solara Active Pharma Sciences’ multiproduct manufacturing facility at Cuddalore. The Agency, with its designated investigators, inspected the Cuddalore facility between July 31, 2023 - August 04, 2023. The inspection established that the facility is in an ‘Acceptable State of Compliance’ with Zero Form 483 inspectional observations from the Agency.
With this successful inspection outcome, the current inspection classification of Cuddalore site shall be reinstated to NAI (No Action Indicated). This facility has also successfully completed the regulatory inspections carried out by the World Health Organization (WHO) between January 23 - 26, 2023 and EU-GMP Inspection carried out jointly by the ‘State Institute for Drug Control (SUKL), Ministry of Health of the Czech Republic’ and ‘National Authority of Medicines and Health Products (INFARMED), Portugal’ between February 07 - 09, 2023.
Solara Active Pharma Sciences is a young, dynamic, entrepreneurial and customer oriented API manufacturer.
