The US drug regulator warned Wockhardt Ltd’s UK subsidiary CP Pharmaceuticals Ltd (currently known as Wockhardt UK Ltd) over violations of quality norms at its manufacturing plant in Wrexham.
Wockhardt acquired CP Pharma in 2003 for £10.85 million (Rs.82.46 crore then), key to expanding in Europe, a market which contributed 48% to total revenue in year ended March.
The FDA’s warning to the UK subsidiary found fault within three key areas—prevention of contamination, investigating the failure of production batches or components to meet specifications and assuring appropriate standards for product strength, quality and purity.
