Sun Pharma Receives FDA Warning for Dadra Facility

Sun Pharmaceutical Industries Ltd has received a warning letter from the US Food and Drug Administration (USFDA) regarding its Dadra facility, citing violations of Current Good Manufacturing Practice (cGMP) regulations. The situation followed an inspection in December 2023 and previous intimation of Official Action Indicated (OAI) status in April 2024.

Sun Pharmaceutical Industries Ltd announced on Wednesday that it has been issued a warning letter by the US Food and Drug Administration (USFDA) for its Dadra facility. The warning identifies multiple violations related to Current Good Manufacturing Practice (cGMP) regulations.

According to Sun Pharma's regulatory filing, the USFDA will make the contents of the warning letter public in the near future. This follows an Official Action Indicated (OAI) status received by the Dadra facility from the USFDA after an inspection between December 4 and December 15, 2023.

The company had previously communicated the OAI status to stock exchanges on April 11, 2024.

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