>latest-news

Cadila Faces FDA Heat For Ignoring Good Manufacturing Practices

FDA warns Cadila for GMP lapses at Ankleshwar plant, risking export license without corrections.

Breaking News

  • Jul 17, 2024

  • Mrudula Kulkarni

Cadila Faces FDA Heat For Ignoring Good Manufacturing Practices

The US Food and Drug Administration (FDA) has issued a warning to Cadila Pharmaceuticals Ltd, citing alleged lapses in good manufacturing practices at its Ankleshwar facility in Gujarat. This plant, known for producing bulk drugs, has previously been flagged for failing to meet quality standards, as noted in a letter addressed to Rajiv Modi, the chairman and managing director of the privately owned pharmaceutical company. Additionally, the FDA mentioned customer complaints regarding foul odours emanating from its active pharmaceutical ingredients, urging Cadila to provide a response within 15 days.

The US regulator issued a statement which stated, “The deficiencies our investigator found lead us to question the effectiveness of your current quality system to achieve overall compliance with CGMP (current good manufacturing practices) at your facility. It is apparent that you have not implemented a robust quality system at your firm."

On November 11th, the FDA published a letter on its website. In response, Cadila’s representative stated via email on Wednesday that the company is working to resolve the concerns raised by the US regulatory body. Recently, several Indian pharmaceutical firms have faced scrutiny from the FDA for failing to meet quality standards. Among those investigated are Sun Pharmaceutical Industries Ltd, Ranbaxy Laboratories Ltd, and Wockhardt Ltd. The regulator has already prohibited all four of Ranbaxy's factories and two of Wockhardt's plants in India from exporting drugs to the US. Without implementing the necessary corrections, Cadila also risks losing its license to export to the US, the world's largest market for generic drugs.

The letter further stated, “Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, it may withhold approval of any new applications or supplements listing your firm as an API manufacturer. In addition, your failure to correct these violations may result in FDA refusing admission of articles manufactured at Cadila Pharmaceuticals Limited in Ankleshwar, Gujarat, India into the US.”

Ad
Advertisement