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.

Free Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This webinar will discuss the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

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.

Read more on

Suggested Articles

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.

Continuing its expansion efforts, Japan’s Fujifilm will make a major investment in its U.S. gene therapy operation in Texas.