Wockhardt Shendra plant yet to get Irish regulator's nod

This comes within a week of USFDA issuing a warning letter to Wockhardt's manufacturing unit in US

Wockhardt, which has received warning letters from the US Food and Drug Administration (FDA) on four of its plants, has now fallen foul of Ireland’s drug regulator.

The Irish drug regulator did not recommend the renewal of the certificate of good manufacturing practices (GMP) for the company’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, when it said the Irish regulator had recommended renewing the GMP certificate. The development comes within a week of the FDA 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 done 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 has not said anything on the issue. However, in its notification to the stock exchange it had said that the Irish regulator had “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 UK, Irish and domestic markets. Last January the FDA had made nine adverse observations following an inspection at the plant.  

The company does not disclose its sales in Ireland. It had acquired Irish drug maker Pinewood Laboratories in 2006 and runs a manufacturing unit there.

Wockhardt's two plants in Aurangabad and the active pharmaceutical ingredients manufacturing unit in Ankleshwar have import alerts against them. 

At present, the company is able to export two products from an Aurangabad plant 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 a 66 per cent fall in its US revenues over the last four years.