NAICS UNIVERSITY · Free research for insurance agents
Pharmaceutical Preparation Manufacturing
NAICS 325412 · United States · 2022 edition
This U.S. industry comprises establishments primarily engaged in manufacturing in-vivo diagnostic substances and pharmaceutical preparations (except biological) intended for internal and external consumption in dose forms, such as ampoules, tablets, capsules, vials, ointments, powders, solutions, and suspensions.
Start the review with products liability.
For Pharmaceutical Preparation Manufacturing, the saved research highlights products liability, product recall / contamination, workers' compensation. Confirm how these arise in the actual operation, what controls are used and whether additional services change the proposed coverage.
Questions to ask
- What product types and therapeutic categories does the facility manufacture, and are any controlled substances involved?
- Is the operation a contract manufacturer (CMO), a branded manufacturer, or both?
- What is the distribution channel — direct to hospitals, wholesalers, retail pharmacy, or consumer?
- Has the company had any product recalls, FDA enforcement actions, or warning letters in the past five years?
- What quality management certifications or third-party GMP audits are in place?
- For Pharmaceutical Preparation Manufacturing, what should the underwriter know about production of schedule ii-v controlled substances, opioids, or other high-litigation therapeutic categories?
- For Pharmaceutical Preparation Manufacturing, what should the underwriter know about prior product recalls, fda warning letters, consent decrees, or import alerts?
- For Pharmaceutical Preparation Manufacturing, what should the underwriter know about significant product liability loss history or pending litigation?
Activities described by this code
Other activities to examine
- Manufacturing uncompounded medicinal chemicals and their derivatives: 325411 — Medicinal and Botanical Manufacturing
- Manufacturing in-vitro diagnostic substances: 325413 — In-Vitro Diagnostic Substance Manufacturing;
- Manufacturing vaccines, toxoids, blood fractions, and culture media of plant or animal origin (except for diagnostic use): 325414 — Biological Product (except Diagnostic) Manufacturing
Census classification reference
For educational purposes only. AI-generated insurance research and automated logic can contain errors. Independently verify classification and coverage decisions.
Compare another operationInsurance operations research — draft
Pharmaceutical preparation manufacturers formulate, compound, and package finished dose-form drug products — tablets, capsules, vials, ampoules, ointments, solutions, and suspensions — for distribution to wholesalers, pharmacies, hospitals, or other pharmaceutical companies. Operations typically involve controlled manufacturing environments, strict GMP (Good Manufacturing Practice) compliance, quality control laboratories, and regulated raw material handling. Many facilities operate as contract manufacturers (CMOs) producing under other companies' labels.
Questions to investigate
- What product types and therapeutic categories does the facility manufacture, and are any controlled substances involved?
- Is the operation a contract manufacturer (CMO), a branded manufacturer, or both?
- What is the distribution channel — direct to hospitals, wholesalers, retail pharmacy, or consumer?
- Has the company had any product recalls, FDA enforcement actions, or warning letters in the past five years?
This insurance research was generated in April 2026. It has not received a complete human review. The October 12, 2026 audit checked codes and titles only, not descriptions or coverage assertions.