USFDA

USFDA rescinds letter to Aurobindo Pharma unit

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Aurobindo Pharma on Friday said the US Food and Drug Administration (USFDA) inspection of its Unit IV, a general injectable formulation manufacturing facility here, is “still open and under review.” This follows the regulator rescinding a 90-day VAl (Voluntary Action Initiated) letter it had issued to the company on February 18. In a regulatory filing, … Read more

Indian pharma industry has come of age, says USFDA official

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A senior official in the US Food and Drug Administration (USFDA) office in India has emphasised the importance of effective and timely communication from pharma companies in their engagement with the health regulator. Companies that had been issued Form 483, post an USFDA inspection, have to respond within 15 days. They can seek more time … Read more