Drug Industry Daily
July 12, 2013
Generic drugmaker Wockhardt suffered another regulatory setback Thursday when British regulators recalled 16 different products, roughly one week after ordering the Indian company to stop making products for Europe.
The precautionary recall, due to good manufacturing practice (GMP) violations, is one of the largest in "recent times," a spokesperson for the UK Medicines and Healthcare products Regulatory Agency (MHRA) told DID Thursday.
The FDA also put the drugmaker on import alert in May for GMP issues.
MHRA wants pharmacies, clinics and wholesalers to return the products but isn't asking patients to return or discontinue using them because there is no evidence of a safety risk.
The recall stems from a March inspection of Wockhardt's Waluj, India plant. MHRA said inspectors found a "low risk of cross-contamination because of poor cleaning practices and defects in building fabric and the ventilation systems at the site." The agency also chided Wockhardt for forging staff training documents.
The recall was the latest blow to Wockhardt, which last week received a statement of non-compliance with GMP guidelines from MHRA. The statement effectively stops the company from making products for Europe, the agency said.
Wockhardt's facility has gotten attention for GMP violations before. The FDA issued a warning letter in 2006, noting that control records were incomplete and inaccurate and documentation of environmental monitoring was delayed for eight months.
It is unclear how the latest regulatory actions will affect the company's finances. U.S. sales contributed to 52 percent of Wockhardt's global revenues in fiscal year 2013, an investment report reads. European business also grew by 22 percent in fiscal year 2013, although business in France declined by 55 percent.
The 16 recalled drugs, which treat a variety of conditions from Parkinson's disease to epilepsy, include clopidogrel, erythromycin, metformin, pantoprazole and risperidone.
MHRA said it is working with Wockhardt, the FDA and other international regulators to resolve the manufacturing issues so that manufacturing of drugs at Waluj can resume.
Generic drugmaker Wockhardt suffered another regulatory setback Thursday when British regulators recalled 16 different products, roughly one week after ordering the Indian company to stop making products for Europe.
The precautionary recall, due to good manufacturing practice (GMP) violations, is one of the largest in "recent times," a spokesperson for the UK Medicines and Healthcare products Regulatory Agency (MHRA) told DID Thursday.
The FDA also put the drugmaker on import alert in May for GMP issues.
MHRA wants pharmacies, clinics and wholesalers to return the products but isn't asking patients to return or discontinue using them because there is no evidence of a safety risk.
The recall stems from a March inspection of Wockhardt's Waluj, India plant. MHRA said inspectors found a "low risk of cross-contamination because of poor cleaning practices and defects in building fabric and the ventilation systems at the site." The agency also chided Wockhardt for forging staff training documents.
The recall was the latest blow to Wockhardt, which last week received a statement of non-compliance with GMP guidelines from MHRA. The statement effectively stops the company from making products for Europe, the agency said.
Wockhardt's facility has gotten attention for GMP violations before. The FDA issued a warning letter in 2006, noting that control records were incomplete and inaccurate and documentation of environmental monitoring was delayed for eight months.
It is unclear how the latest regulatory actions will affect the company's finances. U.S. sales contributed to 52 percent of Wockhardt's global revenues in fiscal year 2013, an investment report reads. European business also grew by 22 percent in fiscal year 2013, although business in France declined by 55 percent.
The 16 recalled drugs, which treat a variety of conditions from Parkinson's disease to epilepsy, include clopidogrel, erythromycin, metformin, pantoprazole and risperidone.
MHRA said it is working with Wockhardt, the FDA and other international regulators to resolve the manufacturing issues so that manufacturing of drugs at Waluj can resume.