Ranbaxy's Mohali unit also facing trouble with US FDA

For Ranbaxy Laboratories, troubles seem to be unending. After Paonta Sahib and Dewas units, now its Mohali unit is likely to be in trouble, said a report in the Business Standard.

After an inspection of the unit, the US Food and Drug Administration has issued Form 483, which indicates that the regulator has found that the conditions at the unit violates the US Food, Drug and Cosmetic Act. However, the company is still making regulatory filings from the unit, the report said.

Both the company and the FDA have neither confirmed nor denied the move, the report said.

[caption id=“attachment_899861” align=“alignleft” width=“380”] Reuters[/caption]

As per the report, the company’s drug Valsartan, generic of a Novartis product, is yet to get the US approval, which was earlier seen coming in September.

An industry source has told the newspaper that the company has not resumed US supply of Lipitor generic from the unit. The company had recalled the drug after suspicion of presence of glass particles.

Ranbaxy also did not resume supplies of Lipitor generic from Mohali to the US, after it had to recall the drug because of a suspected presence of glass particles. Instead, it restored supplies only from its US-based Ohm Laboratories.

According to the report, though the company has filed for approvals for drugs from the unit, nothing has come forth over the last six months or so.

These are all indications of trouble at the unit, which has been key to the company after its other two Himachal Pradesh units got into trouble with the US FDA.

The public, however, is unlikely to come to know of the truth at all, as it is not binding on the company to make any disclosure about such a development.

Meanwhile, the Supreme Court will today hear the public interest litigation seeking cancellation of manufacturing licence for the company.

Reacting to the news, shares of the company were down 3.8 percent at Rs 336 on the BSE.

Read the full Business Standard report here .