Advanced Freeze Dryer

Forecast overview

Subagency

FDA

NAICS

333415

Program office

CDER ACQUISITION

Approximately 70% of FDA-approved antibiotics and most injectable drugs use lyophilization (freeze-drying) during manufacturing. OPQR conducts lyophilization research to support review of generic and new drugs, facility inspections, staff training, and guidance development for these critical drug products. The proposed equipment will support complex generics, biologics, and essential medicine manufacturing and product quality research. The lyophilizer with advanced process monitoring and control capabilities will support assessment of manufacturing quality, develop science-based regulatory standards. This equipment will strengthen FDA's ability to ensure the safety, efficacy, and quality of lyophilized drugs that reach patients.

Source

Source

HHS SBCX Forecast Export

Source file

Forecast.csv

Official source

Agency forecast source

Last verified

2026-08-31

Agency-published contact: · TBD@fda.hhs.gov

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