Claris LifeSciences gets clean bill of health from FDA
pharmafile | August 20, 2012 | News story | Manufacturing and Production, Sales and Marketing | Claris, FDA, Pfizer, sterile
Indian drugmaker Claris LifeSciences seems to have set its house in order after manufacturing issues led the FDA to impose an import ban on some of its products.
Claris has been sent a ‘close-out’ letter by the FDA, which indicates that the Agency is satisfied with the corrective actions implemented by the drugmaker at its production plants in Ahmedabad and North Brunswick, New Jersey, which were the subject of a warning letter sent in November 2010.
Claris said in a statement that it had not yet received official notification of the close-out, but it believes that all the violations detailed in the latter have been resolved satisfactorily.
The company specialises in the manufacture of sterile injectable medicines and operates as a contract manufacturer for a number of generic pharma companies as well as selling products under its own label.
Claris had received complaints from customers about intravenous bags contaminated with fungus and bacteria.
For example an intravenous formulation of the antibiotic metronidazole product was found by one customer (Pfizer) as well as a US distributor (Sagent Pharmaceuticals) to be contaminated with a Cladosporium fungal species, potentially placing patients at risk of serious and potentially fatal infections.
That case forced Pfizer to recall four lots of metronidazole, ciprofloxacin and nausea drug ondansetron, which together totalled around 1.7 million intravenous bags.
Despite the manufacturing issues and block on sales in the US, Claris’ business has been growing briskly in the face if rising demand for sterile injectable drugs elsewhere in the world.
The company reported first-half revenues of 3.75 billion rupees ($67 million), a rise of around 15% with more than half of sales coming from overseas markets. Earnings before interest depreciation amortisation and taxes (EBITDA) came in at 1.31 billion rupees.
Phil Taylor
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