Dishman Carbogen Amcis Limited has informed the Exchange regarding ''.COMPANY S NARODA UNIT RECEIVED ESTABLISHMENT INSPECTION REPORT (EIR) FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION (US FDA)
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Dishman Carbogen Amcis has received the Establishment Inspection Report (EIR) from the US FDA for its Naroda facility in India, confirming the closure of an inspection conducted between June 9 and June 12, 2025. The EIR indicates that the inspection was successfully closed with no adverse observations. With this, the company's facilities in Bavla and Naroda (India), along with multiple sites in Switzerland and the Netherlands, continue to be US FDA approved. This is a routine but important regulatory milestone for a pharmaceutical company that supplies to the US market.
Positive for shareholders — the clean EIR closure removes regulatory uncertainty and confirms the Naroda unit remains compliant with US FDA standards, supporting continued exports and business with US clients.