Advanced Freeze Dryer

Department of Health and Human Services

Forecast Overview

NAICS
333415
Performance end
1/2026

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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