MHRA gives troubled Wockhardt plant all clear to manufacture for UK
The contractor announced the certificate in a statement filed with the Bombay Stock Exchange yesterday.
“The Company has undergone recently an inspection at its L1-Chikalthana, Aurangabad manufacturing facility by UK MHRA and have received a communication confirming the closure of the inspection and issuance of an unrestricted GMP certificate,” the firm said.
This was confirmed with the European database of GMP compliance, which shows the certificate, was issued on November 27, six weeks after the MHRA inspection which at the time Wockhardt said resulted in no critical observations.
The plant – which makes generic drugs and antibiotics – has previously been the subject of considerable regulatory criticism.
In October 2013 it was banned from exporting products to the UK after the country’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a certificate of non-compliance due to cGMP violations.
A month after the MHRA’s original suspension, the plant was hit by the US Food and Drug Administration (FDA) which issued an import alert in November 2013, banning exports of all but five essential medicines made at the site.
In January this year the ban expanded to include all active pharmaceutical ingredients (APIs) made at the facility.
“The Company has undergone recently an inspection at its L1-Chikalthana, Aurangabad manufacturing facility by UK MHRA and have received a communication confirming the closure of the inspection and issuance of an unrestricted GMP certificate,” the firm said.
