Solara Active Pharma Sciences Limited has informed the Exchange regarding a press release titled "Solara is pleased to announce the successful closure of US FDA inspection of its Mangalore Facility with continued state of compliance on cGMP".
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Solara Active Pharma Sciences announced that the US FDA has successfully closed inspection of its Mangalore manufacturing facility. The facility maintained a continued state of compliance with cGMP (current Good Manufacturing Practice) standards, with no adverse observations reported. This outcome allows uninterrupted manufacturing and supply of products from this facility to the US market. The Mangalore facility is a key manufacturing site for Solara's Active Pharmaceutical Ingredients (API) business.
Positive for shareholders as it removes regulatory uncertainty around the Mangalore facility, supports continued US exports, and avoids any supply disruptions that an adverse FDA action could have caused.