Sandoz’s contracted fill/finish partner Pfizer, a key part of the supply chain for the Glatopa line, has received an FDA warning letter.
Pfizer says the warning doesn’t restrict production or shipment of the Glatopa 20 mg product, but the 40 mg ANDA is still under regulatory review.
Approval of that application is dependent on satisfactory compliance at Pfizer’s facility, and Momenta says such an approval is unlikely in the first quarter of 2017.
Momenta promises more details on its earnings call, set for Tuesday at 8 a.m. ET.