Compliance problems at Strides’ Puducherry unit; FDA posts Aurobindo’s warning letter

By PharmaCompass

2019-07-04

Impressions: 126 Article

Strides Pharma Science informed the bourses it has received a warning letter from the US Food and Drug Administration (FDA) pertaining to its Puducherry facility. In May 2019, the FDA had classified Strides’ Puducherry facility as Official Action Indicated (OAI),

The Puducherry site currently produces six ANDAs and the company said in its filing that these will not get impacted by the current development.

Although the company has stated that it retains its growth guidance for the US market, 10 ANDAs pending approval from the site will get deferred till the site is reclassified.

Strides’ journey is similar to Aurobindo’s whose facilities were first classified as OAI following which the company informed the stock market that it had received a warning letter. This week, Aurobindo’s warning letter for its Unit XI was posted on the FDA’s website which provided insights into the agency’s concerns overs the firm’s ‘sartan’ API manufacturing operations.

Although the warning letter is heavily redacted, it seems that the investigations made by the firm into the root cause of the carcinogenic nitrosamine impurities were found deficient. The firm’s initial assessment determined that the manufacturing process did not have the potential to produce the cancer-causing impurities. This, of course, was not the case as Aurobindo’s valsartan and irbesartan APIs triggered a series of drug recalls after nitrosamine impurities were detected.

Aurobindo’s quality unit has also been cited for failing to report to the FDA levels of non-carcinogenic impurities which exceeded acceptance limits.

In addition, the FDA raised concerns over rust covering the surface of equipment used in manufacturing.

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