Why pharmaceutical manufacturing is changing fast
US pharmaceutical manufacturing is moving back onshore, pushed by trade policy and pulled by FDA programs. FDA states that “More than half of pharmaceuticals distributed in the U.S. are manufactured overseas” and that among makers of APIs used in FDA-approved products, “only 11% are U.S. manufacturers” (FDA). Commissioner Makary called this “overreliance on foreign drug manufacturing” a national security risk.
For quality and manufacturing teams, the result is a wave of new plants, technology transfers and supplier changes, each of which must meet GMP from the first commercial batch.
The 2025 and 2026 policy picture
| Development | Date | What it means |
|---|---|---|
| Unannounced foreign inspections expanded | May 6, 2025 | FDA “intends to expand its use of unannounced inspections at foreign manufacturing facilities” (Hogan Lovells) |
| FDA PreCheck launched | Aug 7, 2025 | Earlier FDA engagement for new US plants, in a facility readiness phase and an application phase (FDA) |
| Section 232 tariffs on patented drugs proclaimed | Apr 2, 2026 | 100% tariff on patented drugs and their APIs, 15% for some trading partners, with exemptions tied to onshoring plans and pricing agreements; generics and biosimilars “expressly excluded” for now (Crowell) |
| Tariffs take effect | Jul 31, 2026 (Sep 29, 2026 for listed companies) | Import costs now depend on where products and APIs are made |
Trade rules are changing quickly; confirm current rates with trade counsel before acting.
FDA programs that help new and modernized plants
FDA PreCheck. The Facility Readiness Phase gives manufacturers more frequent FDA contact during design, construction and pre-production, and encourages a facility-specific Type V Drug Master File that applications can reference. The Application Submission Phase focuses on the chemistry, manufacturing and controls (CMC) section through pre-application meetings (FDA).
Advanced Manufacturing Technologies (AMT) designation. FDA finalized this guidance in December 2024. It applies to methods that “incorporate a novel technology or use an established technique in a novel way,” and designation “allows for early and frequent interaction with FDA” (Sidley). Continuous manufacturing and other modern approaches fall in this space.
The GMP work behind a new or transferred process
New plants fail inspections for the same reasons old ones do. In FY2025, the most cited drug observations were quality unit procedures (243), investigations (164) and production procedures (162) (GMP Insiders). A new site has to build all of these before its first batch:
- Quality unit and QMS with written authority, procedures and trained staff.
- Facility and utility qualification: design, installation, operation and performance.
- Technology transfer package: process knowledge, critical parameters, analytical methods and acceptance criteria.
- Process validation: design, qualification and continued verification.
- Analytical method transfer or validation at the receiving lab.
- Computerized system validation for MES, LIMS, QMS and equipment control.
- Supplier qualification for new or re-sourced APIs and components.
- Regulatory filings that match what the plant actually does.
Pharmaceutical manufacturing readiness checklist
- Site quality unit staffed and procedures approved before production
- Facility, utilities and equipment qualified
- Technology transfer documents complete and reviewed by the receiving site
- Process validation plan aligned with filed process
- Analytical methods transferred or validated
- Computerized systems validated, with data integrity controls
- New suppliers qualified and audited
- PreCheck or AMT engagement considered for new US facilities
- Tariff and sourcing assumptions reviewed with trade counsel
- Mock inspection completed before commercial launch
Check transfer and readiness documents with evidence
Technology transfers generate thousands of pages, and gaps between sending and receiving sites cause later deviations. AskDona reviews tech transfer packages, validation protocols and SOPs against 21 CFR 211, ICH guidelines or your own procedures, flags gaps and inconsistencies with the filed process, and cites the passage behind every finding.
Run a sample tech transfer document assessment on one transfer package. AskDona shows the evidence; your quality and manufacturing teams decide.
FAQ
What is pharmaceutical manufacturing? The production of drugs and their ingredients under GMP, from API synthesis to finished dosage forms and packaging.
What is FDA PreCheck? An FDA program launched in August 2025 to support new US drug manufacturing facilities through earlier engagement (FDA).
Are generic drugs subject to the 2026 pharmaceutical tariffs? Generics and biosimilars are excluded for now under the April 2026 proclamation (Crowell).
What is an advanced manufacturing technology designation? An FDA designation for novel manufacturing methods that gives early and frequent FDA interaction (Sidley).
What do new plants most often get wrong? Quality unit procedures, investigations and production procedures, the top FY2025 drug citations.
References
All pages opened and checked by October 14, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| FDA: PreCheck program | Regulator | Aug 7, 2025 | Onshoring statistics, program phases |
| Hogan Lovells: Unannounced foreign inspections | Law firm | May 8, 2025 | Inspection policy |
| Crowell: Section 232 pharmaceutical tariffs | Law firm | Apr 7, 2026 | Tariff structure |
| Sidley: AMT designation guidance | Law firm | Jan 17, 2025 | AMT program |
| GMP Insiders: FY2025 observations | Trade analysis | Jan 5, 2026 | Drug citation counts |