---
name: Stason Industrial Corporation
slug: stasonpharma
site: cdmo
website_domain: stasonpharma.com
summary: US-based CDMO offering contract packaging, analytical testing, and manufacturing services for clinical trial and commercial pharmaceutical products, with specialized high-containment capabilities for potent compounds down to 0.1 µg/m³ OEL. Headquartered in Irvine, United States.
tagline: High-potency CDMO with specialized containment and global manufacturing partnerships.
founded_year: 1994
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: US
tier2_domain_verified: false
updated_at: 2026-10-12T07:04:28.138Z
services_count: 2
modalities_count: 1
indications_count: 3
locations_count: 2
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Stason Industrial Corporation

High-potency CDMO with specialized containment and global manufacturing partnerships.

Listed on cdmo.directory.

## Summary

US-based CDMO offering contract packaging, analytical testing, and manufacturing services for clinical trial and commercial pharmaceutical products, with specialized high-containment capabilities for potent compounds down to 0.1 µg/m³ OEL. Headquartered in Irvine, United States.

## At a glance

- Founded: 1994
- HQ country: US

## Services

- Analytical Method Development & Validation
- ICH Stability Studies

## Modalities

- Small Molecule

## Indications

- Oncology
- Nephrology
- Rare Disease

## Locations

- Headquarters, Irvine, California, United States
- Manufacturing Partner, Tainan, Taiwan

## Long description

## Overview

Stason Industrial Corporation is a US-based contract development and manufacturing organization (CDMO) headquartered in Southern California. The company entered the commercial generic market in 1994 and has expanded to offer comprehensive contract manufacturing and analytical services to drug-development companies ranging from virtual start-ups to top-20 pharma companies.

## Core Services

**Manufacturing Capabilities:**
- Solid dosage forms (tablets and capsules) with capacity exceeding 2 billion oral doses per year
- Batch size capacity from 0.5 kg to 600 kg
- Injectable and liquid manufacturing through partnership with Standard Chem. & Pharm. Co. Ltd. in Taiwan (lyophilization, suspension, powder filling)
- Semi-solid dose formulations (bench-top through Phase 2 clinical trial production)
- Packaging services: automatic encapsulation (50,000 capsules/hour), automatic packaging lines (up to 100 bottles/minute), unit dose blister design and development

**High Containment Operations (HCO):**
- Closed manufacturing system handling highly potent compounds down to occupational exposure level (OEL) of 0.1 µg/m³ or less
- Multiple dedicated processing suites with dedicated packing room, remote data acquisition system, and documentation room
- Segregated facility with 40 air changes per hour
- SafeBridge® Category 1-4 compound handling

**Quality Control & Stability Testing:**
- QC testing for Active Pharmaceutical Ingredients (APIs), pharmaceutical intermediates, excipients, and finished products
- ICH-compliant stability chambers (25°C/60%RH, 30°C/65%RH, 40°C/75%RH, and customized conditions)
- Long-term, accelerated, comparative stability testing and forced degradation studies
- Full generator backup for environmental chambers

**Facility Infrastructure:**
- Irvine, California manufacturing facility: ~37,000 sq. feet in sprinkler-equipped concrete building
- Class 100,000/ISO Class 8 clean rooms with 12-foot minimum ceilings
- Temperature control: 18–24°C with minimum 20 air changes per hour (standard operations) and 40 changes per hour (high-containment)
- cGMP-compliant quality control systems with strict adherence to regulatory requirements

## Regulatory & Compliance

Stason complies with all applicable environmental, occupational health and safety, public health and safety, and waste disposal regulations. The company holds all current and applicable governmental licenses, approvals, permits, and authorizations. Quality-by-Design (QbD) principles guide CMC regulatory review and manufacturing processes.

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_Profile last updated: 2026-10-12T07:04:28.138Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.