Just four weeks after authorities in Germany pulled the manufacturing authorization from one Dr. Reddy’s plant in India, it has blocked a manufacturing certificate from another one there.
Dr. Reddy’s in a public filing Friday said that the Regulatory Authority of Germany cited its formulations plant in Duvvada, Visakhapatnam, with six major violations after concluding an inspection there Sept. 7
The drugmaker said that while the plant is not currently shipping product to the European Union, it has been told it won’t win that privilege until authorities there sign a corrective and preventive action plan (COPA). Dr. Reddy’s reported it is preparing a COPA
In August, the Central Authority for Supervision of Medicinal Products in Bavaria cited a Dr. Reddy’s plant in Bachupally, India, that has already run into issues with the FDA.
Among other critical deficiencies, the regulator said the plant’s protocol, review and reporting systems were designed to systematically skirt reporting "discrepancies, nonconformances, incidents and unusual events.”
The drugmaker has already had its finances torpedoed by repeated citations of its plants by the FDA. It was hit with a scathing three-facility warning letter in 2015 that has impeded its ability to launch new drugs in the U.S. The FDA has cleared one of those three plants but the other two continue to operate under the overhang of that warning letter.
As a result, Dr. Reddy’s sales in the U.S. were down 16% in the last fiscal year to 63.6 billion rupees ($993 million). Then in its first quarter of this fiscal year, it saw its profits slide 53% to about $9.2 million from about $19.7 million in the same quarter a year ago.
The FDA has gone on to take a close look at other Dr. Reddy’s plants. Last spring, the Indian drugmaker said an inspection of a formulations plant in Bachupally in Hyderabad resulted in a Form 483 with 11 observations. It was not the same plant that German regulators cited.