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Indian Pharmaceutical Manufacturer, Cadila, Receives FDA Warning Letter

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India Pharmaceutical Manufacturing

Following announcement of the FDA-issued warning letter, Cadila shares dropped by almost 17 percent.

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January 6, 2016 | by Sarah Massey, M.Sc.

The US Food and Drug Administration (FDA) continues its crackdown on quality of pharmaceuticals manufactured at plants in India. Cadila Healthcare is the latest to receive a warning letter from the agency for activities conducted at the company’s plants in Moraiya and Ahmedabad, though as of yet it’s unknown exactly what issues were identified at the facilities.

The FDA issued a number of warnings to other India-based drugmakers in 2015, including Sun Pharmaceutical, Mylan’s sterile injectable manufacturers, and Dr. Reddy’s Laboratories. Cadila also received an FDA warning letter in February of 2015 citing the company’s failure to adequately investigate complaints, failure to ensure active pharmaceutical ingredients (API) were manufactured in compliance with CGMP, and failure to prevent unauthorized access or changes to data.

According to the company, none of the Zyfine APIs manufactured in the plant in Ahmedabad were used to create products for export to the US. “We take quality and matters very seriously and stand by our commitment to fully comply with current good manufacturing practice regulations (cGMP) quality standards across all our facilities,” said Cadila in a statement to the Bombay Stock Exchange. “The company is working hard to ensure that the commitments made to the FDA are fully completed.”



“The company will continue to take all necessary steps to ensure that the FDA is fully satisfied with our remediation of the above facilities,” Cadila continued in the letter. “We will respond to FDA to address the observations within the statutory time permitted in the letter. We are committed to resolve all the issues and revamp our quality systems and processes as the top most priority.”

Following announcement of the FDA-issued warning letter, Cadila shares dropped by almost 17 percent. According to figures published in The Telegraph, Cadila received $151 million in US-generated revenue in the second quarter, almost 60 percent of which is attributed to manufacturing activities to the company’s plant in Moraiya.

Drugs manufactured in India account for almost 40 percent of all generics imported into the US. Indian drugmakers not only face the challenges associated with meeting the standards of the FDA, but also slower approvals of new drugs and a shortage of local industry inspectors.

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Keywords: India, FDA, Pharmaceutical Manufacturing


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