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# Momenta Glatopa Fill/Finish Contractor Warned
- URL: https://www.fdaweb.com/momenta-glatopa-fill-finish-contractor-warned/
- Published: 2017-02-21T12:00:00.000Z
- Updated: 2026-09-14T22:07:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138019

Momenta says that a Pfizer facility that is a key fill/finish supply chain partner for the company’s Glatopa (glatiramer acetate injection) products has received an FDA Warning Letter that will likely delay agency approval of a Glatopa 40 mg ANDA. The Warning Letter does not restrict production or shipment of the Glatopa 20 mg product now marketed in the U.S. by Sandoz, Momenta [says](http://files.shareholder.com/downloads/MNTA/3926000989x0x928706/9fc3719b-041d-4432-8a9d-0c0e161bcafd/MNTA%5FNews%5F2017%5F2%5F17%5FGeneral%5FReleases.pdf?ref=fdaweb.com). It says it is working with Sandoz to resolve the Pfizer issue to allow for ANDA approval for the 40 mg product as soon as possible.