UI Pharmaceuticals

What UI Pharmaceuticals does

UI Pharmaceuticals is a contract development and manufacturing organization (CDMO) founded in 1974 within the University of Iowa College of Pharmacy, operating as a state-entity division of the public research university rather than as a privately-held corporation. The company provides formulation development, sterile and non-sterile manufacturing, lyophilization, terminal sterilization, and comprehensive analytical testing services to pharmaceutical companies, biotechnology startups, government agencies, and academic institutions. With over 60,000 square feet of manufacturing and laboratory space across multiple Iowa City facilities, UI Pharmaceuticals operates FDA-registered, cGMP-compliant infrastructure including ISO 5 cleanroom environments with isolator technology, DEA licensing for controlled substances schedules I-V, and EMA GMP compliance for European market access.

The company's core technical capabilities span the full pharmaceutical development lifecycle: formulation development for both sterile and non-sterile dosage forms, clinical supply manufacturing, small-scale commercial manufacturing, analytical method development and validation, stability studies, and quality control testing. The recently validated $26 million sterile processing facility features twin fully automated ISO 5 isolator fill lines equipped with TelStar Lyomega 80ST lyophilizers, supporting batch sizes up to 200 liters and annual capacity for 2 million sterile filled vials and 1 million lyophilized vials. Additional capabilities include handling of potent and cytotoxic compounds (SafeBridge categorization 1-3), comparator product manufacturing for blinded clinical trials, and Qualified Person (QP) release services for European clinical trial supply.

UI Pharmaceuticals generates revenue through project-based fee-for-service contracts, with pricing determined by manufacturing scope, batch sizes, regulatory complexity, and service requirements across multi-year contractual arrangements. The go-to-market approach combines dedicated business development outreach with active participation in major pharmaceutical industry conferences including BIO International Convention, AAPS PharmSci 360, and Contract Pharma Contracting & Outsourcing Conference. The company has supported multiple FDA-approved drugs through its manufacturing services, including COSELA (trilaciclib) for G1 Therapeutics, and reports that over 95% of its work addresses unmet medical needs. Service delivery spans the United States, European Union, South Korea, and Israel, with the organization self-funded through operations and capital investments from the University of Iowa rather than venture capital or equity financing.

Name

UI Pharmaceuticals

Legal name

University of Iowa Pharmaceuticals

Website

https://uip.pharmacy.uiowa.edu

Company type

Private

Founded year

1974

Operating status

Operating

Headcount range

51–100 employees

Short description

UI Pharmaceuticals is a University of Iowa-affiliated CDMO providing formulation development, sterile and non-sterile manufacturing, lyophilization, and analytical testing services to pharmaceutical, biotech, and government clients since 1974.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro industry

PRIMARYHLAGABAH

Sterile Fill-Finish & Aseptic Manufacturing CDMO

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Development & Manufacturing Organizations (CDMO)

SECONDARYHLAGABAB

Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Development & Manufacturing Organizations (CDMO)

SECONDARYHLAGABAK

Clinical Trial Material (CTM) Manufacturing & Supply CDMO

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Development & Manufacturing Organizations (CDMO)

Keywords

• Contract pharmaceutical manufacturing
• Aseptic fill-finish services
• Lyophilization manufacturing
• Analytical testing services
• Clinical trial material manufacturing

Headquarters

HQ city

Iowa City

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Pharmaceutical Manufacturing: UI Pharmaceuticals generates revenue by providing fee-for-service pharmaceutical manufacturing and testing services to clients. Services include clinical supply manufacturing, small-scale commercial manufacturing, analytical method development and validation, routine quality control analysis, and stability studies. Revenue is project-based with pricing determined by scope, batch size, and complexity of manufacturing requirements.
2. Analytical Testing Services: Revenue generated from providing comprehensive analytical services including API release testing, in-process and finished product analyses, cleaning verifications, stability studies, and method development. Services are billed based on testing scope and volume.
3. Formulation Development Services: Pre-formulation studies, formulation development for sterile and non-sterile products, lyophilization cycle development, and manufacturing process development services are provided on a fee-for-service basis.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

UI Pharmaceuticals is a contract development and manufacturing organization (CDMO) operating as a service arm of the University of Iowa College of Pharmacy. The company provides cGMP-compliant pharmaceutical manufacturing, aseptic fill-finish, lyophilization, formulation development, analytical testing, and clinical/commercial batch production for pharmaceutical and biotech clients.

Product overview

UI Pharmaceuticals is a Contract Development and Manufacturing Organization (CDMO) founded in 1974 within the University of Iowa College of Pharmacy. The company operates over 60,000 square feet of state-of-the-art manufacturing and laboratory space, offering comprehensive pharmaceutical development and manufacturing services. Its core product portfolio includes: Formulation Development (pre-formulation, sterile and non-sterile formulation, lyophilization cycle development, and pilot-scale manufacturing); Sterile Manufacturing (fill-finish, lyophilization, terminal sterilization, and specialty filling across multiple facilities including the new $26M CPB facility); Non-Sterile Manufacturing (tablets, capsules, powders, liquids, semisolids, and comparator products); Analytical Services (method development, validation, stability assessment, and quality control testing); and Quality Assurance (cGMP compliance, release support, and QP services for EU markets). The company serves pharmaceutical, biotech, and government clients worldwide.

Differentiator

Problem solved

Functional benefit

Products and services

• Aseptic Fill-Finish Manufacturing
• Lyophilization Services
• Formulation Development
• Analytical Testing Services
• Clinical Trial Material Manufacturing
• Stability Studies
• cGMP Storage

Quantifiable outcome

• 100% technology transfer success rate for products developed within the organization
• +3 more outcomes

Named customers11 records

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core.

• Center for Biocatalysis and Bioprocessing (CBB)coreStrategic or Co-development PartnerCBB is a full-fledged microbial pilot plant facility at the University of Iowa Research Campus, FDA cGMP compliant. UI Pharmaceuticals and CBB co-exhibit at industry events and collaborate on projects requiring protein production and biocatalysis capabilities. Services range from cloning genes to strain selection with fermentation processes scaled up to 1000L and GMP protein production for Phase I clinical trials at 300L scale.
• TPQ Consultancy, Ltd. (Russell Thomson)coreOthersUI Pharmaceuticals partners with Russell Thomson, Managing Director and Principal Consultant of TPQ Consultancy, Ltd. in the UK, who serves as their Qualified Person (QP) for EU clinical trial releases. Russell conducts QP audits and provides GMP Audit Certificates confirming compliance with European Commission Directive 2003/94/EC requirements.

Scale indicators11 records

Recent moves10 records

Expansion highlights5 records

Regional players

• Aenova Group: European-headquartered CDMO with solid, semi-solid, and sterile capabilities. Comparable service portfolio to UI Pharmaceuticals but primarily serves EU markets rather than competing head-to-head in the US.

Broad incumbents

• Lonza: Global CDMO leader with the largest sterile fill-finish footprint in the industry. Competes with UI Pharmaceuticals across clinical and small-scale commercial sterile work but at vastly greater capacity and geographic reach.
• Thermo Fisher Scientific (Patheon CDMO): Diversified life sciences conglomerate with a major CDMO business (formerly Patheon) offering sterile, oral solid, and analytical services globally. Competes with UI Pharmaceuticals across most service lines but as part of a much broader portfolio.

Direct peers

• Curia (formerly AMRI): US-headquartered CDMO providing formulation development, sterile and non-sterile manufacturing, and analytical services. Comparable scale and service breadth to UI Pharmaceuticals with similar biotech customer focus.
• PCI Pharma Services: Sterile injectable and lyophilization CDMO serving biotech and large pharma across clinical and commercial supply. Directly comparable in core sterile fill-finish offering to UI Pharmaceuticals' new CPB facility.
• Tapestry Bio (formerly DPT Laboratories): US CDMO focused on sterile injectable, semi-solid, and liquid manufacturing for biotech and specialty pharma. Comparable in scale and semi-sterile/sterile service mix to UI Pharmaceuticals.
• Vetter Pharma: Specialist CDMO focused on aseptic filling of complex injectables and lyophilized products. A benchmark for the kind of premium sterile fill-finish capability UI Pharmaceuticals is building out in its new $26M CPB facility.
• Catalent: Global leader in sterile fill-finish, lyophilization, and oral dose CDMO services. Competes with UI Pharmaceuticals for the same sterile injectable and clinical supply work but at much greater scale and geographic reach.
• Alcami Corporation: US-based mid-size CDMO offering sterile fill-finish, oral solid dose, and analytical services to pharma and biotech. Closely comparable to UI Pharmaceuticals in scale, service mix, and target customer segment of small-to-mid biotechs.
• Kindeva Drug Delivery: Mid-size CDMO with sterile injectable and combination product capabilities serving pharma and biotech. Comparable in scale and target customer mix to UI Pharmaceuticals' sterile operations.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@uipharmaceuticals533/about
• Facebookfacebook.com/uipharmatalktous
• LinkedInlinkedin.com/company/the-university-of-iowa-pharmaceuticals

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

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 UI Pharmaceuticals