No drugmaker likes to have regulators rain on its parade, but for Indian drugmaker Wockhardt, the bad news is pouring down like a monsoon. The U.K. has stopped most exports from a third plant in four months after finding problems.
In an announcement to Indian stock exchanges today, Wockhardt said that the Medicines and Healthcare Products Regulatory Agency (MHRA) had yanked its good manufacturing certificate for a plant in Kadaiya, Nani Daman. It is getting a restricted permit allowing it to continue to manufacture some drugs that otherwise would be in short supply. According to The Wall Street Journal, Wockhardt said the plant does not make products for the U.S. market, which in May banned a different Wockhardt plant from shipping to the U.S.
The action by the MHRA comes after the regulators this month also banned most products from a Wockhardt plant in Chikalthana. It is also allowing that plant to continue to export drugs that are essential for the EU market, but it did order Wockhardt to recall 5 products made at that plant. The move against the Chikalthana plant followed a similar action that the U.K. and the U.S. both took to ban products from a plant in Waluj earlier in the year. The MHRA had insisted Wockhardt recall 16 drugs when the Waluj plant was cited.
The FDA followed its ban of Wockhardt's Waluj site with a warning letter citing it for a variety of manufacturing and sanitation issues. It said that quality-assurance personnel tried to hide records of batch failures and destroy samples that inspectors wanted to examine. Inspectors also found leaking toilets and a puddle of urine in a bathroom near a sterile manufacturing area. That plant has an oral solid unit and two injectable units. The company told investors in August that the FDA is allowing it to continue to import its enalapril product, a generic of the blood pressure med Vasotec, that it manufactures there.
- find the announcement here
- read the Wall Street Journal story (sub. req.)