USFDA approves Dr Reddy Lab’s UK plant after seven-month scrutiny

The United States Food & Drugs Administration has closed its audit of the UK manufacturing plant of Dr Reddy’s Laboratories, the Indian pharmaceutical company said.

In September last year, the company had announced that the US FDA issued a Form 483 with three observations regarding operations at the pharmaceutical drug manufacturing plant at Mirfield, leading to a sharp correction in the stock.

Form 483 is issued when the inspectors notice discrepancies that, in their opinion, need to be fixed.

The company said at the time it would try to work with the US FDA to address the concerns highlighted by the observations.

Today, it said: “We would now like to inform you that we have received an Establishment Inspection Report (EIR) from the US FDA, for the above-referred facility, indicating closure of the audit.”

The Mirfield facility manufactures active pharmaceutical ingredients, which are the biologically active components used in medicines.

The company, founded by Anji Reddy, and has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products.

It started as a supplier to Indian drug manufacturers, but it soon started exporting to other markets.

By the early 1990s, the expanded scale and profitability from these unregulated markets enabled the company to begin focusing on getting approval from drug regulators for their formulations and bulk drug manufacturing plants in more-developed economies.