FDA warns Cadila Pharma over drug production processes

| | Updated on: Nov 12, 2014

The U.S. Food and Drug Administration (FDA) has warned privately owned Indian drugmaker Cadila Pharmaceuticals Ltd that it was not following quality and manufacturing standards at one of its plants, which caused impurities in drug ingredients made there.

Cadila Pharmaceuticals is the latest Indian drugmaker to face U.S. regulatory rebuke, as the FDA intensifies its scrutiny of the generic drugmakers.

The United States is the biggest market for India's $15-billion generics manufacturing sector, but a series of regulatory sanctions on large drugmakers including Ranbaxy Laboratories Ltd and Wockhardt Ltd over the past year have hurt the country's reputation as a supplier of safe and affordable drugs.

In a warning letter posted on its website late on Tuesday, the FDA said inspectors in March had found "significant deviations" from standard manufacturing practices at Cadila Pharmaceuticals' Ankleshwar plant in Gujarat state.

The FDA issued the letter on Oct 15, and gave the company 15 days to respond. If Cadila Pharmaceuticals fails to take measures to correct the violations, the agency can ban exports to the United States from the plant.

A spokesman for Cadila Pharmaceuticals, which supplies drugs to more than 85 countries including the United States, Japan and Kenya, did not immediately respond to a request for comment.

The FDA said the inspection showed the company did not adequately probe or take corrective action after customer complaints between 2011 and 2012 about unpleasant odours from, and impurities in, certain drug batches sold in the United States.

Published on March 12, 2018

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