The facility located in the Aurangabad region of India had its good manufacturing practice (GMP) certificate withdrawn by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) last month, and yesterday the FDA published details of its own warning and import alert for products made from the site.
Acknowledging the ban in a filing to the Bombay Stock Exchange, Wockhardt said: “The Company has received a Warning Letter from USFDA for its manufacturing units located at L1, Chikalthana, Aurangabad and B15, Waluj, Aurangabad.
“USFDA has also posted on its website an import alert on the manufacturing unit at L1, Chikalthana, Aurangabad,” it continued.
The plant manufactures a number of generic drugs and antibiotics, all but five of which - Bethanechol Chloride, Ceftriaxon, Enalapril Maleate, Divalproex sodium and Venlafaxine Hydrochloride - will be banned from being imported into the US until further notice. One drug the firm manufactures from the site is Metoprolol XR - a generic of Novartis’ hypertension drug Lopressor - will fall under the import alert, Wockhardt specified.
According to the filing: “The Company has already initiated several steps to address the observations made by the USFDA and shall put all efforts to resolve the matter at the earliest.”
Second Import Alert & Cost to Business
This is the second Wockhardt facility this year to be hit by an import alert due to GMP violations. In May, drugs from the firm’s Waluj oral solid dose facility - also in Aurangabad - were also placed under Detention Without Physical Examination (DWPE) by the FDA following an earlier inspection.
Just weeks later the MHRA issued Wockhardt a statement of non-compliance for the Waluj site effectively suspending manufacture from the site.
At the time, Wockhardt Chairman Habil Khorakiwala said end of year revenues could be affected by as much as $100m because of the ban.
In-Pharmatechnologist.com attempted to contact the company by phone and email to discuss how Wockhardt was responding to this latest warning but at the time of going to press we received no response.
Following this latest alert, share price dropped by as much as 13.5%.