Dr. Reddy’s says FDA hit its API plant in Hyderabad with Form 483

Dr. Reddy's
Dr. Reddy’s said the FDA has issued one of its API plants a Form 483 following a recent inspection. (Dr. Reddy's)

Indian drugmaker Dr. Reddy’s said that following an inspection, the FDA issued a Form 483 to its API Hyderabad Plant 1, citing four issues.

The company announced the news today in a filing (PDF) to the Bombay Stock Exchange, saying only that the facility located Jinnaram Mandal, Medak District was issued a Form 483 “with four observations which will be addressed comprehensively within stipulated time.”

In a separate and unrelated announcement today, the company said it launched levocetirizine dihydrochloride tablets in the U.S., an OTC antihistamine used for 24-hour relief of allergy symptoms such as watery eyes, runny nose, itching eyes/nose and sneezing.

The U.S. regulatory agency has put Dr. Reddy’s under intense scrutiny in the past few years. Last spring, the Indian drugmaker said an inspection by the FDA of a formulations plant in Bachupally in Hyderabad resulted in a Form 483 with 11 observations.

In November, German regulators signed off on a corrective and preventive action plan (CAPA) for one of Dr. Reddy’s formulation production at another of its facilities in India, allowing the company to market drugs manufactured at the site for the European Union.

Being under the regulatory magnifying glass has had a fiscal impact on the company. Last May, the company reported that revenues in North America were off 16% to 63.6 billion rupees ($993 million). At the time, Dr. Reddy’s said the slump was due to increased competition to a key drug in the market but also acknowledged that the FDA's problems with its manufacturing had again taken a toll.