Stason Pharmaceuticals

What Stason Pharmaceuticals does

Stason Pharmaceuticals, Inc. is a privately held US-based pharmaceutical company headquartered in Irvine, California, operating as a subsidiary of Stason Industrial Corporation since 1994. The company operates across five distinct business lines: a Generic Division marketing 30+ approved ANDAs in oncology, CNS, cardiovascular, and dermatologic indications; a Brand Division (launched 2008) developing New Chemical Entities and 505(b)(2) products with proprietary compounds; Stason Biologics (2012) targeting Asia Pacific biosimilars and biologics; Stason Animal Health (2011) serving veterinary markets; and PharmaVibes Research (2025) for consumer supplements.

Core technical capabilities center on cGMP pharmaceutical manufacturing with specialized High Containment Operations (HCO) handling highly potent compounds down to occupational exposure levels of 0.1 µg/m3 or less, conforming to SafeBridge Category 1-4 standards. The ~37,000 sq. ft. Irvine facility produces over 2 billion oral doses annually with batch sizes ranging from 0.5 kg to 600 kg, supported by ICH stability chambers, DEA analytical permits for CII-CIV controlled substances, and DSCSA-compliant L1-L4 serialization infrastructure integrated with Optel Vision and Tracelink. Injectable and liquid manufacturing capabilities are delivered through a strategic partnership with Standard Chem. & Pharm. Co. Ltd. in Tainan, Taiwan.

The business model combines B2B enterprise sales with project-based CDMO services, multi-year contract manufacturing agreements, licensing royalties from cross-territorial partnerships spanning 9 countries, and consumer product e-commerce. GTM motion relies on direct business development outreach to drug development companies ranging from virtual startups to top-20 pharma, supplemented by active presence at major pharmaceutical conferences (J.P. Morgan Healthcare Conference, CPhI series, DCAT Week, AAPS). Revenue streams are diversified across one-time licensing, professional services, and hardware sales models, though specific revenue figures and pricing are not publicly disclosed.

Name

Stason Pharmaceuticals

Legal name

Stason Pharmaceuticals

Website

https://stasonpharma.com

Company type

Private

Founded year

1989

Operating status

Operating

Headcount range

101–250 employees

Short description

Stason Pharmaceuticals is a US-based private pharmaceutical company operating generics, CDMO services, branded NCEs, biologics, and consumer supplements divisions, with specialized high-containment manufacturing capabilities serving drug development companies and global licensing partners across 9 countries.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

akta.pro secondary industries

Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Small-Molecule API & Intermediates CDMO (HLAGABAA), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), GMP Scale-Up, Tech Transfer & Process Validation (PPQ) (HLAGAHAL), Cardiometabolic Pharmaceuticals (Cardiovascular/Diabetes/Obesity) (HLAIAAAE)

Keywords

• Pharmaceutical contract manufacturing
• Generic drug development
• High containment manufacturing
• Active pharmaceutical ingredients
• Pharmaceutical packaging services

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Supply Chain, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Generic Pharmaceutical Products: Development, manufacturing, and marketing of generic pharmaceutical products filed under ANDA in the US or ANDS in Canada. Portfolio of approved ANDAs marketed through global distributors. Core therapeutic categories include oncology, CNS, cardiovascular, and dermatologic indications. Focus on generics requiring high containment manufacturing, cytotoxic products, and difficult-to-manufacture drugs.
2. Contract Manufacturing / CDMO Services: Full-service CDMO offering from development services (API synthesis, formulation, analytical method development) through manufacturing (clinical trial materials, commercial production). Services for solid, semi-solid, and sterile dosage forms. High containment manufacturing capabilities. Capacity up to 2 billion oral doses per year.
3. Branded Pharmaceutical Products: Brand Division launched in 2008 focuses on New Chemical Entities (NCEs) for unmet medical needs in oncology, CNS, GI, cardiovascular, and orphan indications. Revenue from proprietary compound development, licensing, and acquisition of NDAs. Includes 505(b)(2) products with various oncological indications.
4. Licensing and Distribution Partnerships: Global licensing and distribution partnerships including product acquisitions, in-licensing and out-licensing arrangements. Partnerships with North American, European, and Asian companies for cross-territorial product distribution.
5. Consumer Products: Consumer supplement products including probiotics, botanicals, plant-based protein powders, and oral health mints. Manufacturing division established in 2025 under Stason. Products include PharmaVibes Research branded supplements.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

Stason Pharmaceuticals is a U.S.-based pharmaceutical manufacturer that provides vertically integrated contract development and manufacturing organization (CDMO) services — including API synthesis, pre-formulation, formulation, analytical method development, packaging, serialization, and high containment manufacturing for highly potent compounds — alongside its own portfolio of generic and branded prescription drugs, biologics, animal health products, APIs, and consumer supplements under the PharmaVibes Research brand. The company serves virtual, mid-size, and top-20 pharmaceutical companies through cGMP-certified operations in Irvine, California, supported by global strategic alliances across 9 countries and 13 locations.

Product overview

Stason Pharmaceuticals is a US-based pharmaceutical company offering a comprehensive portfolio of products and contract manufacturing services. The company operates multiple divisions: a Generic Division (established 1994) marketing ANDA-filed generic pharmaceuticals through global distributors; a Brand Division (launched 2008) developing proprietary New Chemical Entities in oncology and other therapeutic areas; Stason Biologics (2012) targeting Asia Pacific biologics markets; Stason Animal Health (2011) for pet health products; and Consumer Products under PharmaVibes Research for supplements including probiotics and plant-based proteins. Contract manufacturing services span the full CDMO value chain including API synthesis, formulation development, analytical testing, clinical and commercial manufacturing, high containment operations (OEL 0.1 µg/m3), serialization for DSCSA compliance, and packaging. The company also offers an API portfolio of 23 pharmaceutical ingredients and global licensing/distribution partnerships.

Differentiator

Problem solved

Functional benefit

Brands

• Stason Biologics: Biologics program targeting Asia Pacific region with proprietary technologies, business partnerships, and commercial facilities in China.
• Stason Animal Health
• PharmaVibes Research

Products and services

• Contract Manufacturing & CDMO Services Vertically integrated contract development and manufacturing services — including API synthesis, pre-formulation, formulation, analytical method development, packaging, and serialization — provided to virtual, mid-size, and top-20 pharmaceutical companies at cGMP-certified facilities in Irvine, California.
• High Containment Operations Specialized cGMP contract manufacturing for highly potent and hazardous pharmaceutical compounds handled at an occupational exposure limit (OEL) of 0.1 µg/m³, available to pharma sponsors requiring safe handling of cytotoxic or otherwise potent actives.
• Generic Pharmaceuticals Stason's commercial portfolio of generic prescription drug products, supported by 30+ approved Abbreviated New Drug Applications (ANDAs), sold to wholesalers, distributors, and pharmacy chains.
• Brand Pharmaceuticals Branded prescription drug products commercialized by Stason, including the acquired Purinethol brand, distributed through licensing and distribution partners.
• Stason Biologics Biological pharmaceutical development and manufacturing products and services offered by Stason's Biologics division to pharma sponsors in the biologics space.
• Stason Animal Health Pharmaceutical products and partnership offerings for animal health and veterinary applications offered through Stason's Animal Health division.
• Active Pharmaceutical Ingredients (APIs) Active Pharmaceutical Ingredient (API) synthesis and supply offered as part of Stason's contract manufacturing capabilities and for use in its own generic drug products.
• Licensing & Distribution Out-licensing and distribution partnerships through which Stason's generic and branded products are commercialized across 9 countries and 13 locations via partner pharmaceutical companies.
• PharmaVibes Research Consumer Products Consumer-focused nutrition, sports nutrition, and wellness supplements marketed under the PharmaVibes Research sub-brand, including Botanicals Central Plant-Based Protein + Creatine and Oral Probiotics Fresh Breath Mints.

Quantifiable outcome

• 2+ billion oral doses per year production capacity
• +2 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature4 records

Partnerships

Ten partnerships are on record, tiered core and minor.

• Optel VisioncoreTechnology or IntegrationSerialization technology partnership for DSCSA compliance. Optel Vision provides line-level (L1) serialization solution for automated printing and inspecting of compliant human readable bar codes for bottle labels and cartons.
• TracelinkcoreTechnology or IntegrationSerialization partnership providing company-level (L1-L4) serialization management. Cloud services for storing and managing Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS). EPCIS repository compliant with GS1 standards.
• Standard Chem. & Pharm. Co. Ltd.coreStrategic or Co-development PartnerManufacturing partnership in Tainan, Taiwan for injectable and liquid dosage forms. Campus1 for injectables (lyophilization, suspension, powder filling, liquids). Campus2 for liquids and ointments. GMP-certified facilities complement Stason's solid dosage capabilities.
• LonzacoreOEM/ Whitelabel/ Licensing PartnerLicense agreement for GS Gene Expression System to develop and manufacture TNT Antibodies. Strategic partnership for biologics development.
• UnilifeminorChannel Partner/ Reseller/ DistributorAsian distribution agreement for Unitract 1mL Safety Syringe. Stason distributes Unilife's safety syringe products in Asian markets.
• Peregrine PharmaceuticalsminorStrategic or Co-development PartnerStrategic partnership to pursue Tumor Necrosis Therapy development in Asia. Co-development pact for oncology therapeutics.
• StamfordminorStrategic or Co-development PartnerUS Biologics and Biosimilar expertise partnership for Asian manufacturers and drug developers. Collaboration to provide US biologics/biosimilar development services to Asian markets.
• Kangen PharmaminorChannel Partner/ Reseller/ DistributorPartner in global strategic alliance network. Listed in global alliances section of website.
• MicrospheresminorChannel Partner/ Reseller/ DistributorPartner in global strategic alliance network. Listed in global alliances section of website.
• QuinnminorChannel Partner/ Reseller/ DistributorPartner in global strategic alliance network. Listed in global alliances section of website.

Scale indicators7 records

Recent moves10 records

Expansion highlights5 records

Direct peers

• Hovione: Privately held CDMO specializing in small molecules, high-potency APIs, and particle engineering. Closest peer to Stason on high-containment, small-molecule, mid-sized, privately held profile.
• Alcami: Mid-sized CDMO providing formulation development, analytical, and small-batch sterile and solid-dose manufacturing for virtual to mid-size pharma. Mirrors Stason's client base of virtual start-ups and mid-size drug developers.
• CordenPharma: CDMO with dedicated high-potency manufacturing (peptides, lipids, HPAPIs) and injectable fill-finish capabilities. Comparable to Stason's high-containment and injectable/liquid offering.
• Recipharm: European-headquartered CDMO with broad solid-dose, semi-solid, and sterile manufacturing capabilities and significant generics exposure. Comparable mid-sized CDMO profile to Stason.
• Piramal Pharma Solutions: Mid-to-large CDMO with explicit high-potency and antibody-drug conjugate capabilities, plus injectable fill-finish. Direct overlap with Stason's high-containment commercial manufacturing focus.
• Cambrex: Small-molecule CDMO offering API and finished dosage form development and manufacturing. Direct comparable to Stason's API-to-drug-product CDMO model before its acquisition by Permira.

Broad incumbents

• Catalent: One of the largest global CDMOs offering small-molecule, biologics, and fill-finish services across all major modalities. Highly comparable CDMO scope, but at far greater scale and broader geographic footprint than Stason.
• Aurobindo Pharma: Vertically integrated generics manufacturer with US ANDA presence and global distribution, plus growing CDMO operations. Comparable to Stason's generics portfolio and global distributor model.

Emerging players

• Avid Bioservices: Mid-sized biologics CDMO focused on mammalian cell culture, fill-finish, and process development. Comparable to Stason Biologics' APAC-focused biologics CDMO positioning.
• Quotient Sciences: Development-focused CDMO offering formulation, clinical manufacturing, and integrated drug development services. Comparable to Stason's formulation/development services submodule.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/stasonpharma
• LinkedInlinkedin.com/company/stason-pharmaceuticals-inc

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Stason Pharmaceuticals