Dr Reddy's clears USFDA inspection of its API Srikakulam SEZ plant with zero observations

Moneycontrol News

Drugmaker Dr Reddy’s said on Saturday that the US FDA had completed inspection of one of its facilities in Srikakulam, Andhra Pradesh without making any observations.

The FDA conducted an audit at its active pharmaceutical ingredient (API) Srikakulam special economic zone (SEZ) plant this week.

The API SEZ plant is a fully automated new generation plant catering to the US market.

This facility has not been issued a warning letter and is up for a routine US FDA audit. The facility is used for filing new products and is also earmarked for transferring manufacturing of certain existing products.

Dr Reddy’s has another API site at Srikakulam, which has received a warning letter. At its post earning presentation recently, the company said it will be responding to the FDA’s queries by end of June and expects resolution without re-inspection.

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