Wockhardt which has received US FDA warning letters on four of its plants is now facing an issue with Ireland's drug regulator.
The Irish drug regulator did not recommend the renewal of good manufacturing practices (GMP) certificate of Wockhardt's Shendra plant in Maharashtra and has advised the drug maker to take corrective actions following an inspection.
This is contrary to the claim made by Wockhardt in its notification to the stock exchange on Tuesday in which it said Irish regulator has recommended the renewal of the GMP certificate.
The development comes within a week of US Food and Drugs Administration issuing a warning letter to Wockhardt's manufacturing unit in the US.
In an emailed response Ireland's Health Products Regulatory Authority (HPRA) said an inspection was carried at Shendra for five days till March 3 covering some non-sterile dosage forms. Injectable dosage forms were not within the scope of the inspection.
"The company (Wockhardt) was advised that corrective actions/preventative actions (CAPAs) are required in relation to the inspection findings. As is the norm for the inspection process, a decision regarding renewal of the GMP certificate (only for those non-sterile dosage forms) will be taken following receipt and review of the CAPAs proposed in order to address the inspection findings," the drug regulator said. It did not comment on Wockhardt's notification to the exchange.
Wockhardt did not offer comments on the issue. However, in its notification to the stock exchange, it had said that the Irish regulator has "recommended the renewal of certificate based on the general compliance with the principles and guidelines of good manufacturing practice of our Shendra manufacturing unit."
Wockhardt's manufacturing facility in Shendra is new and serves the United Kingdom, Irish and domestic markets. Last January, the US Food and Drugs Administration had made nine adverse observations following an inspection at the Shendra plant.
The company did not disclose its sales from Ireland. Wockhardt acquired Irish drug maker Pinewood Laboratories in 2006 and runs a manufacturing unit in that country.
Wockhardt's plants in Chikhalthana and Waluj in Aurangabad and active pharmaceutical ingredients manufacturing unit in Ankleshwar have import alerts against them. At present, the company is able to export only two products from Chikhalthana to the US. Other than this, Wockhardt serves the US market from its manufacturing plant in Morton Grove, near Chicago.
Non-compliance has resulted in 66 per cent fall in US revenue over the last four years. In 2012-13 US business accounted 52 per cent of its operating revenue and in FY 16 it fell to 22 per cent.