Irisys, Inc.

UEI
FHHKP5KCJ5R7
CAGE
5AS49
Primary NAICS
541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
SAM.gov registration
Expired

Company facts

Self-certified in SAM.gov
  • For Profit Organization
  • Manufacturer of Goods
  • Subchapter S Corporation
Entity structure
Corporate Entity (Not Tax Exempt)
NAICS codes registered in SAM.gov
Corporate family
SAM.gov registration date
Website
irisys.com
Founded
1996
Employees
51-250
Estimated annual revenue
$10M-$50M
Industry
  1. Health Care
  2. Pharmaceuticals, Biotechnology & Life Sciences
  3. Pharmaceuticals
SIC code
28 Chemical & Allied Products
Profiles

Registration and certifications come from SAM.gov and the SBA; company details from public web sources. Updated .

Recent federal awards

Irisys, Inc.'s 2 most recent federal contract and grant awards, newest first. Amounts are dollars obligated.
Award Agency Obligated Awarded
Irisys LLC:1259725 [17-009083] Contract · HHSN302201700280P National Human Genome Research Institute $0
TAS::75 0849::TAS development and manufacture of oral and toopical dosage forms Contract · HHSN261201000023C National Cancer Institute $1,308,236

About Irisys, Inc.

Irisys, Inc. is a contract development and manufacturing organization (CDMO) that provides pharmaceutical product development, manufacturing, and testing services to federal government agencies. The company, registered in SAM.gov since January 22, 2009, operates as a for-profit organization and manufacturer of goods. Through its subsidiary, Societal CDMO San Diego, LLC, Irisys primarily supports clinical research and drug development efforts for various components of the Department of Health and Human Services (HHS), including the National Institutes of Health (NIH), National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS), and National Institute on Drug Abuse (NIDA).

The company's federal contract awards predominantly involve the production of various drug formulations for clinical use. These include oral capsules (such as IPDR, AZA-TDC, endoxifen, and decitabine), injectable solutions (like LMP744 and mithramycin lyophilized powder), and potentially other dosage forms. Irisys has been awarded contracts for stability studies and drug testing, which are crucial components of Good Manufacturing Practices (GMP) for pharmaceutical products. The majority of these awards come from civilian agencies within HHS, particularly the National Cancer Institute and the Office of Logistics and Acquisition Operations. The contract types vary but often include cost-plus-fixed-fee and firm-fixed-price delivery orders. While Irisys is registered as a small disadvantaged business, most of its recent awards were not associated with set-aside programs.

Irisys holds multiple Indefinite Delivery Vehicles (IDVs) that allow various NIH components to procure its services. A significant IDV is the Drug Formulation and Manufacturing Contracts 2019, a $45 million multiple-award contract vehicle. Under this IDV, Irisys provides a range of services including drug formulation, manufacturing, and stability testing. Another notable IDV is the NCATS Drug Product Development Studies 2017-2022, under which Irisys has performed stability studies for investigational drugs. These IDVs enable different NIH agencies to issue task orders for specific projects, such as the production of various drug formulations or stability studies, supporting a wide range of clinical research and drug development initiatives. The flexibility of these IDVs allows Irisys to contribute to diverse pharmaceutical development projects across multiple HHS agencies, reinforcing its role as a key partner in federal drug research and development efforts.

Quick answers

What is Irisys, Inc.'s UEI?

Irisys, Inc.'s Unique Entity ID (UEI) in SAM.gov is FHHKP5KCJ5R7.

What is Irisys, Inc.'s CAGE code?

Irisys, Inc.'s CAGE code is 5AS49.

What is Irisys, Inc.'s primary NAICS code?

Irisys, Inc.'s primary NAICS code is 541715 (Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)).

Is Irisys, Inc. registered in SAM.gov?

Irisys, Inc.'s SAM.gov registration expired on March 17, 2022.

What is Irisys, Inc.'s most recent federal award?

Irisys, Inc.'s most recent federal contract award is Irisys LLC:1259725 [17-009083] (HHSN302201700280P), from National Human Genome Research Institute, on September 14, 2017.

On GovTribe

See Irisys, Inc.'s full federal record

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  • IDV awards
  • Contract vehicles
  • Funding analysis by agency, NAICS and set-aside
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