Patheon resumes Omnicef production after suspension
after it voluntarily suspended production in September at it
facility in Carolina, Puerto Rico, due to a US Food and Drug
Administration (FDA) manufacturing warning.
CEPH International, acquired by Patheon in its 2004 purchase of rival company Mova, received the FDA warning letter, citing a failure to control and correct out-of-specification fill weights for certain versions of the Omnicef powder.
The problems are said to predate the company's acquisition of Mova.
Patheon said the recent resumption follows qualification of new equipment and validation of processes for manufacturing of the product, in accordance with a plan developed by CEPH to respond to the FDA warning letter.
The company said it has achieved satisfactory test results on the new product batches, which it has since released to Abbott Laboratories, who it makes the product for under contract.
CEPH has also notified the FDA that it has resumed normal production and shipments and said that it will be prepared for an FDA reinspection to verify the implementation of the corrective actions.
The affected product included powder for oral suspension, Omnicef OP 250 mg/5mL and 125 mg/5mL, which is diluted with a liquid prior to being given to children as an antibiotic to treat ear, sinus, throat and skin infections.
Omnicef is also available in capsule form, however, the capsules were not affected by the product suspension.
Patheon, a leading contract manufacturing organization, had warned that its fourth-quarter earnings would be negatively impacted due to the production suspension and costs related to fixing the situation.
However, despite this, the company, which released its fourth-quarter earnings on Tuesday, revealed a profit jumped of 180 per cent comared to Q4 of 2004.
