Strides Pharma: Puducherry plant classified as OAI by USFDA

The US drug regulator has as classified Strides' Puducherry facility under the Official Action Initiated (OAI) category, the company informed in a press release.

The company stated that the US Food and Drug Administration (USFDA) has conducted an inspection of the facility between January 28 to February 5. The classification was communicated to the company last week on Saturday, May 4.

Strides Pharma has expressed disappoint regarding the outcome of the inspection, but has clarified the classification will not effect the company's current supplies and revenue generated from the plant. However, 10 pending ANDA approvals have been filed through this facility, which will be delayed due to this classification. The company will have to wait until the plant is reclassified by the USFDA. Strides Pharma has 34 pending ANDA approvals with the USFDA.

The company's earning conference call is scheduled for Friday, May 10.

Reacting to the announcement, coupled with negative market sentiment, at 12:00 hours, the stock of Strides Pharma Science was at Rs. 470.00 per share, down by Rs. 12.30 or 2.55 per cent on Monday.