Ups and downs for Pfizer in contract manufacturing

Pfizer CenterOne, the contract manufacturing arm of Pfizer, has notched a win and a loss for its drug fill-and-finish business. The firm plans to expand its fill-and-finish operations with new facilities at its Kalamazoo, Mich., site. The expansion will encompass vial filling of small molecules, biologics, and sterile suspensions. But separately, Pfizer received an FDA warning letter regarding fill-and-finish work being done at its McPherson, Kan., facility for Momenta Pharmaceuticals’ Glatopa, a multiple sclerosis treatment. An Abbreviated New Drug Application for a 40-mg dose is currently under regulatory review, with approval dependent on the satisfactory resolution of compliance problems at the Pfizer plant. Momenta says an approval in the first quarter is unlikely. Pfizer has indicated that the warning letter does not restrict production or shipment of the 20-mg dose of the drug, currently approved in the U.S. Momenta codeveloped the drug, a biosimilar of Copaxone, with Sandoz.