USFDA classifies Sun Pharmaceutical Halol facility as OAI

On December 13, 2019, Sun Pharmaceutical had informed that USFDA’s inspection at the company’s Halol (Gujarat) facility from December 3 to 13, 2019 had led to the issuance of form 483 by USFDA with eight observations.

Now, the company has received a communication from USFDA indicating that Halol facility has been classified as official action indicated (OAI). The OAI classification implies inter alia that USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved. The company’s 19 ANDAs and two NDAs are pending approval from Halol for US market.

The company continues to manufacture and distribute existing products for US market thereby, not likely to have any adverse impact on the current business from the facility. It does not anticipate any major supply disruption for existing products due to OAI classification and would work with USFDA to ensure that there is no shortage in supplies to US market. US supplies from Halol, as of now, contribute approximately three to four per cent of its consolidated revenue.

Sun Pharmaceutical continues to cooperate with USFDA and will undertake all necessary steps to resolve these issues to ensure that the regulator is completely satisfied with the company’s remedial action.  

On Monday, the stock of Sun Pharmaceutical Industries Ltd opened at Rs 329, down 2.7 per cent from its previous close of Rs 338.15 on BSE. In the early morning trading session, it dipped 6.7 per cent to Rs 315.30.