Endo says it will expand capacity at its generic manufacturing subsidiary Qualitest in light of quality lapses and product recall.
End of year figures showed that Qualitest's net sales increased 12% on 2011 and, speaking in a conference call Chief Operating Officer of Endo - parent company of Qualitest - Julie McHugh said the company expects “to continue to invest in the expansion of [its]manufacturing capacity in 2013.”
Speaking of Qualitest, Chief Financial Officer Alan Levin added: “We're investing to capture some of the robust demand that we see for our products. We're looking at 15% increases in capacity annually through 2015.”
Fourth quarter figures were lower than expected and McHugh said this was driven, in part, by a “recall of Hydrocodone products” which significantly added to “back orders of approximately $15 million worth of potential sales.”
Endo Pharmaceuticals acquired Qualitest in 2010, just a year after the manufacturer had voluntarily recalled a batch of insulin syringes due to defects in the drug delivery device.
Further issues with production and packaging have since caused recalls resulting in loss of sales and, with the case of an oral contraceptive drug defect, a series of lawsuits from women who unintentionally fell pregnant.
McHugh ensured shareholders that Endo remained “very focused on continuous improvement of [Qualitest's] manufacturing processes, including [its] quality systems.”
She continued, adding: “We will continue to remain committed to all of those process improvements as we move forward.”
Qualitest Left Holding the Baby?
A packaging error with the blister packs at Qualitest’s Alabama facilities caused the company to recall multiple batches of oral contraceptives in September 2011 yet was unable to avoid a number of women falling pregnant due to the defect and, subsequently, a series of lawsuits.
A recent article in the Kansas City Star focused on the story of Shanta Russell, one of the women who is suing Qualitest’s parent body, Endo for compensation after falling pregnant while taking the pill, and according to the article the Lead Attorney on the case had been approached by over 200 women in a similar situation.
This publication received no response from either Qualitest or Endo with regards to quality issues and the ensuing lawsuits.