---
title: CDMO Daily News — July 4, 2026
slug: daily-news-2026-07-04-cdmo
site: cdmo
post_kind: news
byline: BioBM
description: July 4 CDMO daily: FDA PreCheck Pilot Selects Seven Companies to Expand U.S. Drug Manufacturing Capacity — FUJIFILM Biotechnologies' Holly Springs…
canonical_url: https://cdmo.directory/posts/daily-news-2026-07-04-cdmo
published_at: 2026-07-04T23:59:52.163Z
last_updated: 2026-07-05T00:02:55.818Z
---

### FDA PreCheck Pilot Selects Seven Companies to Expand U.S. Drug Manufacturing Capacity
- FDA announced selection of seven companies for PreCheck Pilot Program, a new initiative providing early regulatory guidance and predictable pathways for domestic pharmaceutical manufacturing facilities.
- Selected participants include Amneal Pharmaceutical (sterile liquids, Long Island), Cellares (cell-based gene therapy, New Jersey), Eli Lilly (APIs, Indiana), [FUJIFILM Biotechnologies](/companies/fujifilmdiosynth) (cell culture, North Carolina), Kriya Therapeutics (AAV gene therapy, North Carolina), Kyowa Kirin (drug substance, North Carolina), and Regeneron (biologics/injectables, New York).
- Two-phase model provides facility-readiness technical guidance via Drug Master Files and expedited pre-submission meetings to accelerate FDA inspection and application review cycles.

**Operational Impact**

[FUJIFILM Biotechnologies](/companies/fujifilmdiosynth)' Holly Springs cell-culture facility gains predictable FDA regulatory milestones and early technical guidance, potentially accelerating commercial-scale biomanufacturing timelines and reducing inspection uncertainty for clients seeking domestic biologics capacity.

*Source: [FDA Press Releases RSS](https://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing)*

## References

1. [FDA Press Releases RSS — FDA PreCheck Pilot Selects Seven Companies to Expand U.S. Drug Manufacturing Capacity](https://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing)

Source: https://cdmo.directory/posts/daily-news-2026-07-04-cdmo