USFDA classifies Sun Pharma's Halol manufacturing site for official action, may put all new approvals on hold

India's largest drug maker Sun Pharmaceutical Industries said its Halol manufacturing site in Gujarat had been classified as Official Action Indicated (OAI) by USFDA.

The OAI status implies that the USFDA may put all new approvals from the Halol facility on hold till the outstanding corrective actions are completed.

Sun Pharma will be able to manufacture and supply already-approved products from the facility to the US market.

But, if the company fails to satisfactorily address the regulatory concerns raised by USFDA, it may get a warning letter. The US drug regulator inspected the plant between December 3 and 13 and issued a Form 483 (inspection report) with eight observations. USFDA classifies an inspection into three categories such as OAI, VAI (Voluntary Action Indicated), and NAI (No Action Indicated). While NAI means clean chit, VAI means minor changes which the company can voluntarily act upon.

The facility has 19 abbreviated new drug applications (ANDAs) and two new drug applications (NDAs) pending approval from Halol for the US market. US supplies from Halol, as of now, contribute approximately 3-4 percent of Sun Pharma's consolidated revenues.

Sun Pharma has consolidated revenue of Rs 28,686.28 crore in FY19.

"We do not anticipate any major supply disruption for existing products due to the OAI classification. We will work with the USFDA to ensure that there is no shortage in supplies to the US market," Sun Pharma said in a statement to stock exchanges.

"Although the Baska facility is USFDA approved and can manufacture injectables, it cannot manufacture some of the dosage forms filed from Halol. Hence, a backup of such products may not be possible," Sun Pharma added.