In November, France’s health regulator l’Agence National de Sécurité du Médicament et des produits de santé (ANSM) suspended manufacturing at Catalent’s softgel development and production site in Beinheim due to the occurrence of out-of-place capsules in several product batches.
The contract development and manufacturing organisation (CDMO) subsequently said the problem was likely to have been “a deliberate malicious action by one or more individuals,” and filed a criminal complaint.
While Catalent told investors in February the facility would be back up to full production in March, four days into April and the firm “has not 8k-ed [filed with the SEC] the reopening of Beinheim, leaving some near-term revenue risk,” according to Jefferies’ analyst David Windley.
However, a spokesperson from the CDMO told in-Pharmatechnologist the site is close to reopening and limited manufacturing activities have begun:
“We have been working very closely with the ANSM and our customers and have already begun production of medically necessary medicines. We aim to resume the full production schedule in the near future.”
The suspension at the plant, which sits about 40km north of Strasbourg, has already affected customer contracts with GSK, for example, postponing the December launch of its male pattern baldness drug Zagallo (dustasteride) in Japan.
It has also had an adverse effect on Catalent’s financial figures, with the firm taking a $21m (€18.5m) hit to its Q2 topline for the six weeks of non-production to December 31 last year. The firm’s third quarter results are therefore likely to suffer through a full three months of suspension at the plant.
In related news, we reported last week that Catalent was issued with a US Food and Drug Administration (FDA) Form 483 with an undisclosed number of observations on March 25 following an inspection at a softgel plant in St Petersburg, Florida.
“The full response to the FDA will be submitted by April 15 and any required actions are being implemented as expeditiously as possible,” the firm’s spokesperson told us.
While the problems at Beinheim and St Petersburg are unrelated, we asked whether the incidents are making Catalent reassess its network as a whole or reinforce its compliance units.
“The St Petersburg facility was previously inspected in December 2013 with only one observation, and has had many other inspections and new product approvals from multiple regulatory agencies over the course of the last several years,” the firm said, adding:
“Catalent operates over 30 facilities across five continents and is subject to hundreds of inspections by over 35 global regulatory agencies and hundreds of customers. We have a robust global Quality Management Systems and are committed to highest standards of quality and regulatory compliance.”