Following an inspection in April by the US Food and Drug Administration (FDA), the company received a 483 due to violations in manufacturing processes at the Waluj, Aurangabad facility. Subsequently the FDA has issued an import alert regarding the detention without physical examination of all drugs coming from the site.
A statement in April in response to the 483 said “Wockhardt is fully committed to follow strong quality cGMP system,” continuing to say the firm had “initiated urgently an accelerated and a comprehensive remedial measure of the observations of USFDA” and was hoping to achieve “full compliance” as quickly as possible.
However, in a conference call with investors on Friday, Chairman Habil Khorakiwala said the import alert could cost Wockhardt as much as $100m in lost revenues for the year, ending March 2014.
Furthermore, the company will not receive any new drug approvals from the site and estimates it will take at least 8 months to get products back into the US market, following new approval application with the FDA.
In the meantime, 80 per cent of Wockhardt’s production will be shifted to two other Indian facilities.
As well as manufacturing generics at the site, Waluj provides contract manufacturing services for beta-lactum antibiotics tablets, sterile powder for injection and conventional solid dose forms with the added capability of dry syrups.
Wockhardt would not offer further comment regarding manufacturing lapses and rectification or regarding client supply when approached by in-Pharmatechnologist.com.
The news comes just days after another Indian manufacturer, Ranbaxy, agreed to pay a $500m settlement after pleading guilty to making and distributing adulterated drugs from its facilities in Paonta Sahib and Dewas, India.