After running afoul of French regulators in 2014 for dozens of violations at a plant in Andhra Pradesh, Indian generics maker Medreich put together a comprehensive action plan to bring it back into compliance. France’s ANSM recently acknowledged that it appears Medreich has met its goals, but it also said it won’t bother going back for the reinspection that could lead to it reinstate Medreich’s certificate of compliance.
Medreich’s problems at the plant that manufactures B-lactam antibiotics were first noted during an inspection in 2013. When the regulator returned in 2014, inspectors cited 58 deficiencies, including one concerning data being faked that was classified as critical. Another 29 were classified as major and included a variety of problems related to cross-contamination, inadequate visual inspections and a "poor level of quality management."
Medreich pulled its products from the market and set about getting the plant in order. The ANSM acknowledged in a report posted by the European Medicines Agency (EMA) this week that it has received and reviewed the action plan from Medreich and that it addresses the issues raised during the inspection.
“However, due to the absence of any national product on the French market and the absence of any pending application involving this site, ANSM will not perform a follow-up inspection of this site to ensure the effective implementation of this action plan.” As a result, it said the “statement of non-compliance previously issued is maintained and the site should not be named on any marketing authorisations whilst this statement remains in place.”
Medreich is owned by Japan's Meiji Holdings, a small conglomerate that manufactures pharmaceuticals as well as candy and dairy products, which bought the Bangalore-based generics maker in 2014 for about $290 million. According to the Medreich website, the company has 8 manufacturing facilities and 2,000 employees worldwide.
- access the ANSM report here
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