Deficiencies Found At Ranbaxy’s Toansa Plant In Punjab

European regulators completed their assessment of manufacturing violations at Toansa plant in Punjab. The regulators found some deficiencies, but it was ascertained that they posed no serious risk to public health.

The regulators said they were satisfied by the corrective measures taken by the company. They also restored the ‘good manufacturing practices’ certificate that was suspended in January 2014.

The US Food and Drug Administration (FDA) had suspended manufacturing of ‘pharmaceutical ingredients’ at the Toansa plant ‘to prevent substandard quality products from reaching the US consumers.’

Ranbaxy is in the process of being acquired by Sun Pharmaceuticals for $3.2 billion.

The European regulators sent their inspectors from Germany, Ireland and the UK, who were joined by inspectors from Switzerland and Australia, the European Medicines Agency (EMA) said in a statement.

“The inspection team concluded that there was no evidence that medicines in the EU market, which have an active pharmaceutical ingredient manufactured in Toansa, were of unacceptable quality or posed any risk to the health of patients taking them,” said EMA. “This conclusion was supported by tests of samples of these medicines, all of which met the correct quality specifications.”

According to the agency, “European regulatory authorities have identified the need to keep the Toansa site under close supervision and this will be done in collaboration with India and other regulatory authorities around the globe.”

Ranbaxy did not immediately comment on the development. The FDA, however, has said it will not lift its ban on Ranbaxy until it is satisfied with the products.