1. German ban on Ranbaxy’s Dewas product expands to entire EU

German ban on Ranbaxy’s Dewas product expands to entire EU

Adding to Ranbaxy's regulatory troubles overseas, certain drugs produced at its Dewas plant have been barred from export...

By: | New Delhi | Published: December 5, 2014 6:22 AM

Adding to Ranbaxy’s regulatory troubles overseas, certain drugs produced at its Dewas plant have been barred from export to all member countries of the European Union for non-compliance to ‘good manufacturing practice’ norms.

The EU sanction follows a decision taken by German authorities in this regard for Ranbaxy’s Dewas plant, which has also faced inspections by authorities from Australia and Canada. Besides, the US drug watchdog FDA has already banned products made at Ranbaxy’s four Indian plants including at Dewas in Madhya Pradesh.

The company said it has discontinued manufacturing of an injectable antibiotic at its Dewas plant, where drug regulators from Europe, Australia and Canada had conducted inspections for various facilities.

The statement followed the German regulator’s decision to bar export of this antibiotic from Dewas plant.

When contacted, an European Medicines Agency spokesperson Monika Benstetter told PTI that the Ranbaxy products that have been found to be in non-compliance to Good Manufacturing Practice (GMP) cannot be imported into the entire European Union.

EU is a 27-member block of European nations, including Germany.

The EMA official further said that the action by the German supervisory authority “means that certain aseptically prepared sterile products produced at Block C of the Ranbaxy’s Dewas site are not GMP-compliant and can therefore not be imported into the EU.

“Products already manufactured in this Block have been assessed and no recall was needed. The remaining Blocks of the Dewas facility, including those manufacturing other aseptically prepared sterile products have been found to be in compliance with GMP,” she added.

The compliant products have been issued GMP certificates and the same have been communicated to all EU authorities.

Without specifying the action taken by the European, Australian and Canadian authorities, Ranbaxy said in a stock exchange filing that the discontinuation of its cephalosporin injectable unit would not have any “significant impact on business”.

The company further said that all these agencies have approved all its facilities for manufacturing Dosage Forms and APIs (Active Pharmaceutical Ingredients) at Dewas including that for oral cephalosporins “with the only exception of the cephalosporin injectable unit”.

Reacting to reports about the latest action by the German authorities, which had also informed the European Union drug regulator about its action, Ranbaxy said, “The development pertains to only the company’s cephalosporin injectable unit at Dewas in Madhya Pradesh.

Ranbaxy said: “The European authorities along with those from Australia and Canada carried out an inspection in June 2014 of all the facilities in Dewas. Well before that time, the Company had decided, to stop producing cephalosporin injectables at Dewas.

“… We wish to state that Ranbaxy’s decision to discontinue manufacture of Cephalosporin injectables would not have a significant impact on the business.”

The company added: “We wish to clarify that the current approvals cover all other facilities (Dosage Forms and APIs) at Dewas, including those producing penem API and injections and oral cephalosporins.”

Ranbaxy, which is in the process of being acquired by Sun Pharma in a USD 4 billion deal, has been at the receiving end from the US Food and drug Administration (USFDA) for violation of manufacturing norms.

In May last year, Ranbaxy had agreed to pay USD 500 million to the US authorities after pleading guilty to felony charges over violation of manufacturing norms at its plants in Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh.

Shares of Ranbaxy Laboratories today closed at Rs 627.55 per scrip on BSE, down 0.48 per cent from it’s previous close.

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