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In an another quality-related setback, Ranbaxy Laboratories has received an import ban in the European Union on its injectable antibiotic manufactured at its cephalosporin injectable unit at Dewas in Madhya Pradesh, after the German authorities issued a statement of non-compliance.

In an email response to dna, European Medicines Agency (EMA) spokesperson said, "The German supervisory authorities issued a statement of non-compliance with good manufacturing practices (GMP) relating to certain products manufactured at Ranbaxy's Dewas site. This statement of non-compliance entered 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."

The company has confirmed that the European, Australian and Canadian authorities have not approved the manufacturing practices at the unit which they inspected in June this year.

In a filing on BSE, it said that the development pertains to only the cephalosporin injectable unit at Dewas in Madhya Pradesh. "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".

However, there is no clarity on whether Australia and Canada, too, would follow suit.The company further said that since then, the 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. "We wish to clarify that the current approvals cover all other facilities (dosage forms and APIs) at Dewas, including those producing penem API & injections and oral cephalosporins," it said, adding that Ranbaxy's decision to discontinue manufacture of Cephalosporin injectables would not have a significant impact on the business.

In an exchange of information between National Competent Authorities (NCAs) of the European Economic Area (EEA) following the discovery of serious GMP non-compliance, the EudraGMDP website pointed out that the latest inspection was carried on June 27, 2014.

According to the website, from the knowledge gained during inspection it is considered that the injectable unit does not comply with the GMP requirements. EudraGMDP is hosted by EMA on behalf of the EU member states.

The nature of non-compliance as given on the website indicated unsatisfactory investigations into media trials failures with deficiencies concerning design and operation of the cleanrooms, controls for preparation (including sterilization) of components and equipment, and controls concerning aseptic filling.

The EMA spokesperson also said, "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 and GMP certificates have been entered into the EudraGMDP database by EU authorities."

According to analysts, there could be some marginal impact if the ban is applicable to the entire European Union. "Germany is a regulated market with majority of business done by tenders. Ranbaxy's cephalosporin sales in Germany is around 2%. But if the ban is for the entire union or if other European countries impose similar import ban on the injectable unit at Dewas, the impact would be much higher," said a pharma analyst.

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Germany bans Ranbaxy's injectable antibiotic in European Union