Pharma Sector Check - Escalating Regulatory Risk To Halt Business In The U.S.: Motilal Oswal

Motilal Oswal Report

The unsuccessful U.S. Food and Drug Administration compliance leading to official action indication, warning letter had adversely impacted the prospective business for Indian pharma companies focussing on the U.S. generics.

Recent instances of Import alert have intensified the regulatory risk significantly on the ongoing base business in the U.S. market.

Interestingly, the timeline for the escalated action by the U.S. FDA has shortened considerably adding further risk to the U.S. generics business.

Halol is the second instance, wherein, the official action indication classification has been escalated to import alert over past six months by the U.S. FDA. The import alert implies that a company would not be able to supply products from this site to the U.S. market, until the facility becomes compliant.

Click on the attachment to read the full report:

DISCLAIMER

This report is authored by an external party. BQ Prime does not vouch for the accuracy of its contents nor is responsible for them in any way. The contents of this section do not constitute investment advice. For that you must always consult an expert based on your individual needs. The views expressed in the report are that of the author entity and do not represent the views of BQ Prime.

Users have no license to copy, modify, or distribute the content without permission of the Original Owner.