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Ranbaxy hit with EU import ban on antibiotic

Indian generics firm’s plant ruled in breach of manufacturing rules
Ranbaxy antibiotic ban

Ranbaxy Laboratories has been banned from exporting its antibiotic cephalosporin to the EU after German regulators ruled that one of the company's facilities did not comply with Good Manufacturing Practice (GMP).

The country's Federal Institute for Drugs and Medical Devices issued a statement of non-compliance to India-based generics firm Ranbaxy concerning part of its Dewas plant in the central state of Madhya Pradesh, where the antibiotic is made.

The Institute's decision follows an inspection that took place in June, according to a filing on the EMA's EudraGMDP database of manufacturing information. Although the report was filed by the German regulator, it will prevent Ranbaxy from exporting any products made at the plant into any EU country.

The inspection by the Federal Institute for Drugs and Medical Devices raised several concerns, including deficiencies in drug manufacturing rooms and the sterilisation of equipment.

However the decision will not affect products that have already been manufactured at the plant, which have been assessed and not deemed to warrant a recall.

The remaining blocks at the Dewas facility, including those manufacturing other aseptically prepared sterile products, have been found to comply with manufacturing standards.

This isn't the first time Ranbaxy has faced an export ban regarding its drugs in the EU or elsewhere.

Earlier this year US regulator the FDA banned the use of drugs manufactured at the Dewas factory after an inspection found that Ranbaxy violated standard manufacturing practices. These violations resulted in a $500m charge that Ranbaxy paid to US authorities after pleading guilty to felony charges.

Meanwhile in June the EMA lifted its suspension on another Ranbaxy plant that had been cited for GMP violations.

The European regulator, which had sent a team of inspectors from Germany, Ireland and the UK, concluded that the firm's facility in the north Indian village of Toansa posed no risk to public health.

Ranbaxy is the subject of $4bn takeover bid from fellow Indian firm Sun Pharmaceutical that would offer its current majority shareholder Daiichi Sankyo a partial exit.

Article by
Kirstie Pickering

5th December 2014

From: Regulatory



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