India drugmaker Wockhardt Ltd said on Wednesday that the Himachal Pradesh (northern India) state drug controller has suspended the manufacture, sale or distribution of the company's fixed-dose combo painkiller.
Wockhardt stated that the drug controller had suspended the fixed dose combination of Dicyclomine Hydrochloride IP 10mg, Tramadol Hydrochloride IP 50mg and Acetamenophen IP 325mg -- but the drugmaker did not reveal the reason for the suspension.
However, the Himachal Pradesh drug regulator told Reuters that the agency was tipped off that Wockhardt was using chemicals banned by the India government to make painkillers.
Wockhardt has been facing an onslaught of regulatory issues both at home and abroad. In March, India's State Food and Drug Administration officials issued "show cause" notices to Wockhardt's three pharma plants in Waluj and Chikalthana villages in Maharashtra and sought explanation about poor GMP compliance. Additionally, the U.S. FDA has already banned export of medicines from several Wockhardt plants to U.S. markets.