Opko Health Inc (OPK): In a regulatory filing, Catalent (CTLT -...

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Saturday, 04/30/2016 10:54:40 AM

Saturday, April 30, 2016 10:54:40 AM

In a regulatory filing, Catalent (CTLT -0.7%) reports that the French drugs regulator, l'Agence National de Securite du Medicament et des produits de sante (ANSM), has lifted its suspension on the operations at its Beinheim, France softgel facility. ANSM notified the company in November 2015 that it had to suspend operations to address quality issues, specifically the misplacement of softgel capsules in several batches that appeared to be intentional. The company has been working with law enforcement and regulators to investigate. The suspension trimmed $21M off the company's top line.

Catalent is the third party manufacturer for OPKO Health (OPK +0.4%) that was the source of the Complete Response Letter OPKO received from the FDA regarding its RAYALDEE New Drug Application. An on-site inspection at its St. Petersburg, FL location resulted in the citing of 14 deficiencies which need to be resolved before approval.