In fresh overseas troubles, drugmaker Ranbaxy Laboratories has been barred from exporting certain antibiotics produced at its Dewas plant to Germany for non-compliance to ‘good manufacturing practice’ norms.
The German health watchdog has also communicated its latest regulatory action against Ranbaxy to the European Medicines Agency (EMA), while the company has already faced several run-ins with the US health regulator FDA about its various plants including at Dewas in Madhya Pradesh.
Germany’s regulator issued a non-compliance report for the Dewas facility where Ranbaxy manufactures cephalosporin antibiotics, after an inspection in June this year, according to European Medicines Agency.
“From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on June 27, 2014, it is considered that it does not comply with the Good Manufacturing Practice requirements,” the EMA said in a notice on its website.
As per the notice, the German regulator found various deficiencies at the plant including unsatisfactory investigations and deficiencies concerning design and operation of clean rooms.
No immediate comments could not be obtained from Ranbaxy Laboratories.
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 for violation of manufacturing norms. Currently all the four plants of the company are banned from exporting products to the US.
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.
Ranbaxy shares ended at Rs 630.60 apiece on the BSE, up 0.89 per cent from its previous close.