UPDATED: Wockhardt problems pile up; U.K. bans second plant

Generic drugmaker Wockhardt is finding itself in a world of hurt as manufacturing problems pile up at its plants in India. U.K. regulators have withdrawn approval for a Wockhardt plant in Chikalthana to manufacture drugs for Europe, after the U.K. and the U.S. both banned products from a plant in Waluj earlier in the year.

The Indian drugmaker informed the Bombay Stock Exchange over the weekend that its good manufacturing practice certificate (GMP) had been pulled for the plant by the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA). It did say that to avoid drug shortages, it would be allowed to continue to make some products for which the European Medicines Agency (EMA) had determined "there is no feasible alternative in the market."

A spokesman for the MHRA said in an email: "We have issued a statement of non-compliance against Wockhardt's site in Chikalthana, India and Wockhardt's contract manufacturer Nestor Ltd in the UK after recent inspections identified a number of manufacturing issues that breach Good Manufacturing Practice (GMP) guidelines." 

The spokesman said there is no indication of a safety risk and that patients should continue to take their medicines. 

The company says it won't know what the financial impact will be until it receives more information from the agency. It did say the plant in Chikalthana brings in about £12 million ($19 million) in sales from the U.K. and European Union, which Reuters says would amount to only about 2% of the company's total revenues last year. But in its report to investors in August, the company acknowledged that U.S. regulators also raised issues during a recent inspection of that plant.

The company has indicated the bans by the U.S. and Europe of its Waluj site will be very costly. It has acknowledged the U.S. ban alone could cost it as much as $100 million in lost revenue. The FDA issued a warning letter for that site that ravaged its operations. Inspectors said plant quality-assurance personnel tried to hide records of batch failures, started to destroy test samples and told inspectors they had been given access to all areas of manufacturing for the U.S., only for the inspectors to learn they had not been shown an area that did cartridge filling for U.S. products. That plant has an oral solid unit and two injectable units. The company told investors that the FDA is allowing it to continue to import its enalapril product, a generic of the blood pressure med Vasotec, that it manufacturers there.

On top of record-keeping problems, investigators found a toilet near the gowning area for the sterile manufacturing area that leaked urine, which stood in a puddle near a drain. Mold and mildew were also found in the area. It said the plant had been warned about sanitation issues in the past. The U.K. reported problems at the Waluj plant that could cause cross-contamination of products. It followed up the FDA action with a ban of its own against the Waluj plant and also ordered the company to recall 16 products for the EU.

The company has said it is working to address the issues raised by regulators at both plants and that consultants it hired to work with it at Waluj have been brought in to help it with the plant in Chikalthana.

- read the announcement
- here's the Wockhardt presentation (PDF)

Editor's note: This story has been updated with a statement from the MHRA.