Sun Pharma facility placed on FDA import alert
Sun Pharma announced to shareholders that its facility located in Halol, India, that the US Food and Drug Administration (FDA) had communicated to the company the results of its inspection, which took placed between April 26 and May 9, 2022.
The outcome saw the FDA place the plant on the import alert list, which effectively bars all future shipments of products manufacture at the site from being accepted onto the US market. This will remain the case until the FDA deems the facility compliant with current good manufacturing practice (cGMP).
According to Sun Pharma, the import alert excludes 14 products that are manufactured at the facility “subject to certain conditions.”
The company stated that the facility is responsible for approximately 3% of its consolidated revenues, which includes 14 of the excluded products. However, in a statement, Sun Pharma outlined: “We are not revising our revenue guidance for the current financial year.”
As of the time of writing, the share price of the company had fallen compared to prior to the announcement, but only by 2%.
In terms of remedial action to be taken, Sun Pharma stated that it continues to communicate with the 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.”
When contacted to learn what action would be taken, a spokesperson for the company did not respond to the request for comment.
In further regulatory news for the company, last month, Sun Pharma’s Mohali facility received an official action indicated (OAI) classification from the FDA. The plant was inspected in August 2022 and received a Form 483, with six observations.
As a result of the FDA’s finding, it could withhold approval of any pending applications until the issues outlined in the observations are resolved. The OAI classification provided to the Mohali facility was also received by the Halol plant in August 2022.
Sun Pharma is the eight largest generics pharmaceutical company in the US, and the market represents 30% of the company’s global revenue. The market is therefore an important one to the Sun Pharma business, though it possesses a total of 43 manufacturing facilities to leverage should it run into issues at individual sites.
