Another facility operated by Ranbaxy Laboratories in India is reported to have failed an inspection by the FDA, potentially adding to its regulatory compliance issues.
A report in India's Business Standard newspaper suggests that Ranbaxy has been issued with a Form 483 notice by the FDA in the wake of an inspection at its plant in Mohali, one of its main production locations in India.
The article also suggests that problems at Mohali were also behind the company's difficulty in securing US approval for its generic version of Novartis' big-selling antihypertensive Diovan (valsartan), which was due to reach the market in September 2012 with first-to-file exclusivity, but remains delayed.
Ranbaxy has been under pressure in the last few years after quality problems at two other facilities in Ponta Sahib and Dewas led to a consent decree with the FDA, which resulted in an import ban and ultimately the imposition of a $500 million fine last month by the US government for selling adulterated medicines.
Ranbaxy had admitted to distributing adulterated drugs that were produced at Paonta Sahib in 2005 and 2006, including batches of acne therapy Sotret (isotretinoin), gabapentin for epilepsy and the antibiotic ciprofloxacin.
Quality lapses continue to plague the company, however, and towards the end of last year, glass contamination led to a recall of a generic atorvastatin product that is made at Mohali and a US facility in New Brunswick operated by Ranbaxy's Ohm Laboratories subsidiary. The company has not indicated which of the plants made the recalled batches.
Ranbaxy has played down the situation at Mohali, saying that it intends to start shipping generic atorvastatin from the plant in the next few months and that it continues to make regulatory filings for products made at the plant. It has declined to comment on whether a Form 483 has in fact been issued.
Last month the Indian company issued a statement highlighting some of the initiatives it has undertaken to bring its operations into compliance, including investments of more than $300 million to upgrade its manufacturing network and boosting the headcount in its quality operations by 36% since 2010.
Indian court rejects domestic probe push
There was better news for Ranbaxy this week however when India's Supreme Court dismissed a lawsuit attempting to open an investigation into whether Ranbaxy has been manufacturing and selling substandard medicines on the domestic market.
The suit was rejected on the grounds that the petitioner (ML Sharma) had based his arguments on the legal proceedings against Ranbaxy in the US, and had no evidence to proffer of wrongdoing in the Indian market.