Sun Pharmaceutical Industries has received a communication from the US FDA determining the inspection classification as "Official Action Indicated" (OAI). The company had earlier announced the US FDA inspection at the Company's Mohali (Punjab) facility from August 03 to August 12, 2022, and the issuance of Form-483 by the US FDA with 6 observations.

Further, the communication states that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved and may initiate additional actions, if any, under the current Consent Decree.

The company continues to manufacture and distribute existing products for the US market, thereby not likely to have any material adverse impact on current business from the facility.

Sun Pharma continues to cooperate with the US FDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company's remedial action.