Ranbaxy units face FDA heat after inspections

TWO manufacturing facilities of Ranbaxy Laboratories are learnt to have come under the scanner of the US Food and Drug Administration (USFDA), the drug regulatory body in the US. All pharma companies have to get USFDA approval for selling medicines in the US. This is in addition to the company’s Paonta Sahib (Himachal Pradesh) plant, which has been the subject of USFDA investigations for the past two years.

USFDA concern:

Sources said that USFDA has given a ‘not approved’ rating to new products manufactured at the facility, although this could not be independently confirmed. In the Batamandi plant, USFDA is learnt to have raised objections over the validation of equipment used to manufacture products at the facility.

For Ranbaxy US is single largest market, and in 2007, its US sales stood at $386 million, accounting for 22.89% of the company’s global sales. It is believed that Ranbaxy’s manufacturing facility in New Jersey is now a major supplier for the US market.

Other companies too like:

Sun Pharma had to withdraw batches of generic metformin tablets, used to treat diabetes, on efficacy grounds. A couple of years ago, USFDA had also asked Wockhardt to correct several deficiencies.

Source: Economic Times


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