Ranbaxy woes continue with antibiotic recall
pharmafile | May 6, 2009 | News story | Sales and Marketing |Â Â Ranbaxy, USÂ
Indian drugmaker Ranbaxy Laboratories has recalled an antibiotic on sale in the US, suggesting that it still has some way to go before it resolves its manufacturing problems.
Ranbaxy said it was voluntarily recalling all lots of its 100mg nitrofurantoin capsules because "certain lots of the products were determined to not be in conformity with the approved laboratory specifications".
The company, which was acquired last year by Japan's Daiichi Sankyo, said the recalled product is unlikely to produce any serious adverse health effects.
"However, there is a remote possibility that the non-conforming product may increase the incidence of local non-serious gastrointestinal adverse events such as nausea and vomiting," it said in a statement.
The move adds to the company's woes in the US, where regulators have identified a number of manufacturing infractions.
In March, the US Food and Drug Administration (FDA) suspended regulatory review of any products made at the firm's manufacturing facility in Paonta Sahib, saying the company had falsified data and test results in a number of product marketing applications, both approved and pending.
In September 2008 the agency placed an import ban on products made in Paonta Sahib and two other Ranbaxy facilities, Dewas and Batamandi, citing non-compliance with Good Manufacturing Practice (GMP) standards. That import ban remains in force.
The regulatory problems have had an impact on Ranbaxy's sales, which fell 4% to 15.6 billion rupees (£208 million) in the first quarter. This drove the firm into a loss of 262 million-rupee (£3.5 million) after-tax, after posting profits of 858 million rupees a year earlier. Sales in the US fell 14%, despite four new approvals from the FDA in the first quarter.
Ranbaxy also said it is investing increasing its manufacturing capacity at Ohm Laboratories, a US facility which manufactures and packages prescription and over-the-counter medicines in solid dose and liquid forms, and is DEA approved to manufacture controlled substances.
Related Content
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
Moderna doses first US patient in phase 1 trial of mRNA-4106 for solid tumours
The START Center for Cancer Research has dosed the first US participant in Moderna’s phase …
Strategic alliance announced between Recipharm and Exela
Recipharm and Exela have announced that they have entered into an exclusive strategic alliance. The …
