USFDA lists Sun Pharma’s Halol unit under ‘import alert’

The Sun Pharmaceuticals Halol factory in Gujarat was placed under import alert on Thursday by the US Food and Drug Administration.

The Import Alert implies that until the facility complies with CGMP standards, all future shipments of products made at this facility may be denied admission to the US market, according to a statement from the pharmaceutical company to the stock exchanges. The USFDA’s Current Good Manufacturing Practices regulations are referred to as CGMP. Systems for ensuring proper manufacturing process and facility design, monitoring, and control are provided by CGMPs.

14 of the company’s products are exempt from this import alert according to the USFDA, subject to some restrictions.

The statement claims that, with the 14 excluded goods indicated above, deliveries to the US market from the Halol facility accounted for around 3% of the company’s consolidated revenues for the year ending March 31, 2022.

The firm declared that it would take all necessary measures to address these problems and make sure that the regulator was wholly happy with the company’s corrective action. It also indicated that it would continue to collaborate with the USFDA.

It declared that it remained dedicated to providing CGMP-compliant goods to its clients and patients around the world.