New Delhi: Cadila Pharmaceuticals Ltd has received a warning from the US Food and Drug Administration (FDA) for allegedly not following good manufacturing practices at its factory in Ankleshwar in Gujarat.

“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," the US regulator said in a letter dated 15 October. “It is apparent that you have not implemented a robust quality system at your firm."

Cadila’s Ankleshwar plant, which produces bulk drugs, has been earlier reported for not meeting quality standards, according to the letter addressed to Rajiv Modi, chairman and managing director of the privately held drug maker. There have been customer complaints of unpleasant odours from its active pharmaceutical ingredients, the letter said, directing the company to respond within 15 days.

The letter was posted on the FDA’s website on 11 November.

The firm is addressing the issues raised by the US regulator, Cadila’s spokesperson said by email on Wednesday.

Indian pharmaceutical companies have been in recent times facing action from the FDA for not meeting quality standards. Some of the companies that have been investigated by the regulator for quality issues include Sun Pharmaceutical Industries Ltd, Ranbaxy Laboratories Ltd and Wockhardt Ltd.

All four factories of Ranbaxy and two plants of Wockhardt in India have been barred from exporting drugs to the US by the regulator.

Cadila too may lose its licence to export products to the US, the largest generic drug market in the world, unless corrective action is taken.

“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," the letter said. “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."

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