Leiters

What Leiters does

Leiters Health, founded in 1926 and operated today as Denver Solutions, LLC (d/b/a Leiters Health), is an FDA-registered 503B outsourcing facility headquartered in Englewood, Colorado, with a second manufacturing site in Buena, New Jersey. The company compounds sterile preparations under cGMP and USP <797> standards — including pre-filled syringes, IV bags, ophthalmic solutions, cardioplegic solutions, and elastomeric pump fills — for acute care hospitals, ambulatory surgery centers, ophthalmology practices, and physician offices across all 50 states and the District of Columbia. Its product portfolio includes branded and proprietary services such as the patent-pending BupiDexEpi three-drug non-opioid pre-filled syringe, an FDA-compliant repackaged Avastin service aligned with the FDA's 2018 Final Guidance for Repackaging of Biologics, and (as of May 2026) the first preservative-free lidocaine 1% pre-filled syringe specifically labeled for intracameral injection. The company also provides a preferred pharmacy fill service for the Avanos Medical ON-Q Pain Relief System.

Leiters monetizes through the sale of cGMP-quality compounded sterile preparations under quote-based committed-volume contracts with tiered committed versus access pricing, billed annually. Distribution combines a regional direct field sales force (account representatives, account managers, and customer service specialists), a network of major healthcare GPO channel partnerships (AmerisourceBergen, HealthTrust, Premier, Vizient, Eye Pro GPO, US Retina, Capis/HealthTrust), and the company's own Leiters Online Ordering Portal (LOOP) supported by phone, email, and fax ordering with a 24-hour pharmacist on-call. The company is privately held and capitalized by healthcare-focused private equity sponsors (WCAS, Frazier Healthcare Partners, HIG Capital, SV Health Investors) alongside strategic equity from major hospital systems including Mayo Clinic, Kaiser Permanente Ventures, UPMC, Intermountain Health, Memorial Hermann, Novant Health, Corewell Health, UNC Health, and Rex Health. The leadership team is led by President and CEO Paul Granberry (ex-Lonza/Bend Research, Perrigo, Allergan, BASF, Dr. Reddy's) and a full C-suite spanning operations, quality, commercial, finance, legal, and product development.

The underlying technology is rooted in regulated pharmaceutical manufacturing rather than digital health: continuous environmental monitoring, full microbiological and chemistry QC testing prior to batch release (sterility, endotoxin, potency, identification, impurities, sub-visible particulate, visual appearance, pH), advanced automation, stability testing, and 503B/FDA inspection track record across multiple health systems and the California Board of Pharmacy. Beyond-Use Dates of 90–180 days and next-day shipping on most items drive inventory and workflow value for hospital and ASC pharmacy teams. Marketing and demand generation span industry events (ASHP Midyear, AANA, AAO, Vizient Connections, Premier Breakthroughs, HealthTrust University, Becker's CPO Summit, NPPA), content assets (white papers, the Summa Health clinical case study, the Compounding Health blog), and the EDSA (End Drug Shortages Alliance) partnership positioning the company around drug shortage mitigation and opioid stewardship.

Name

Leiters

Legal name

Denver Solutions, LLC

Website

https://leiters.com

Company type

Private

Founded year

1926

Operating status

Operating

Headcount range

101–250 employees

Short description

Leiters Health is an FDA-registered 503B outsourcing facility that compounds sterile preparations — pre-filled syringes, IV bags, ophthalmic solutions, and pump fills — for hospitals, surgery centers, and ophthalmology clinics across the United States.

Ownership category

akta.pro rank

Product category

Sterile Pharmaceutical Compounding (503B Outsourcing)

NAICS

Drugs and Druggists' Sundries Merchant Wholesalers (424210), Drugs and Druggists' Sundries Merchant Wholesalers (42421)

SIC

Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122), Pharmaceutical Preparations (2834), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

Specialty Pharmaceutical Distributors (HLAIAJAB)

akta.pro secondary industry

Controlled Substances & Compliance-Focused Pharmaceutical Distributors (HLAIAJAN)

Keywords

• Sterile pharmaceutical compounding
• 503B outsourcing facility
• Pre-filled syringes
• Ophthalmic repackaging
• Hospital pharmacy medications

Headquarters

HQ city

Englewood

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. Compounded Sterile Preparations (503B): Leiters generates revenue through the sale of FDA-registered 503B outsourcing facility-compounded sterile preparations including pre-filled syringes, IV bags, ophthalmic solutions, and ON-Q pump fills to hospitals, surgery centers, clinics, and physician offices. Products are sold via direct sales, GPO contracts, and online ordering. Revenue is driven by committed volume contracts with healthcare system partners, with pricing based on tiered volume commitments and list prices subject to adjustment.

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels7 records

Core offering

Leiters is an FDA-registered 503B outsourcing facility that compounds and packages sterile pharmaceutical preparations under cGMP and USP <797> standards. Its core offering is ready-to-administer compounded sterile medications—pre-filled syringes, IV bags, ophthalmic solutions (including FDA-compliant repackaged Avastin), and ON-Q pain pump fills—supplied to hospitals, ambulatory surgery centers, ophthalmology clinics, and physician offices across the United States.

Product overview

Leiters Health is an FDA-registered 503B outsourcing facility offering a comprehensive portfolio of compounded sterile preparations and pharmacy services. Their core product lines include Pre-filled Syringes, IV Bags, Ophthalmics, ON-Q* System Pharmacy Fill Service, and Pain Services. The company provides ready-to-administer medications for hospitals, surgery centers, clinics, and physician offices. Their pain services portfolio supports multimodal and opioid-free pain management approaches including their proprietary BupiDexEpi (bupivacaine/dexamethasone/epinephrine) pre-filled syringe. Their ophthalmic offerings include repackaged Avastin compliant with FDA biologics repackaging guidance. The ON-Q* System Pharmacy Fill Service is offered through a partnership with Avanos Medical for postoperative pain management. Products are manufactured under cGMP compliance with stability and microbiological testing prior to batch release.

Differentiator

Problem solved

Functional benefit

Products and services

• Pre-filled Syringes Ready-to-administer pre-filled syringes including compounded sterile preparations such as bupivacaine, ropivacaine, lidocaine, ketamine, fentanyl, morphine, and other medications for hospital and surgery center use.
• IV Bags Pre-filled, pre-labeled, ready-to-use intravenous bags including pain management medications such as ropivacaine HCl in sodium chloride solution, for hospital and surgery center use.
• Ophthalmics Compounded sterile ophthalmic preparations including repackaged Avastin, antibiotic injections, dilating agents, topical anesthetics, and other ophthalmic solutions available in syringes, vials, and dropper bottles for eye care clinics and ophthalmology practices.
• ON-Q* System Pharmacy Fill Service Proprietary 503B pharmacy fill service for the Avanos Medical ON-Q Pain Relief System, providing pre-filled ropivacaine HCl pump cartridges (CB004, CB6004, CB6007) for postoperative pain management as a non-opioid alternative for hospitals and surgery centers.
• Pain Services Comprehensive portfolio of ready-to-use compounded sterile preparations for multimodal pain management, including opioid-free options supporting Enhanced Recovery After Surgery (ERAS) strategies, comprising BupiDexEpi, Adenocaine, and various analgesic medications for hospital and surgery center use.
• Bupivacaine/Dexamethasone/Epinephrine Pre-Filled Syringe (BupiDexEpi) Patent-pending sterile combination pre-filled syringe of bupivacaine HCl 0.375%, dexamethasone sodium phosphate 0.01%, and epinephrine 1:200,000, supplied as a 30 mL fill in a 50 mL syringe with a 120-day Beyond Use Date, designed for non-opioid postoperative pain management in hospitals and surgery centers.
• Adenocaine Pre-Filled Syringe Service Brand-named pre-filled syringe service for anesthesia medications supporting hospital and surgery center operations as part of the Pain Services portfolio.
• Repackaged Avastin Service FDA-compliant repackaging service for Avastin (bevacizumab) compliant with the FDA's 2018 Final Guidance for Repackaging of Biologics, supplied as 2.25 mg/0.09 mL repackaged in 0.25 mL syringes for ophthalmic use.
• Lidocaine 1% Pre-filled Syringe for Intracameral Injection Preservative-free lidocaine 1% pre-filled syringe specifically labeled for intracameral injection, designed as an ophthalmic product for healthcare professionals performing eye procedures.

Quantifiable outcome

• Many products are in stock and available for immediate shipment; next-day shipping available on most items
• +2 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature4 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• Avanos MedicalcoreStrategic or Co-development PartnerLeiters offers a preferred proprietary pharmacy fill service for the Avanos Medical ON-Q Pain Relief System through its 503B outsourcing facility in Denver, Colorado. This is a preferred/co-exclusive fill service relationship for ON-Q pumps with ropivacaine HCI and bupivacaine HCI fills.
• VizientcoreChannel Partner/ Reseller/ DistributorVizient is a GPO partner and also listed as an industry partner. Leiters participates in Vizient's drug shortages initiatives and GPO purchasing contracts.
• AmerisourceBergencoreChannel Partner/ Reseller/ DistributorAmerisourceBergen is a GPO partner providing distribution and purchasing contract access for Leiters' products to member healthcare facilities.
• HealthTrust PGcoreChannel Partner/ Reseller/ DistributorHealthTrust is a GPO partner offering purchasing contract access for Leiters' compounded sterile preparations to member hospitals and health systems.
• PremiercoreChannel Partner/ Reseller/ DistributorPremier is a GPO partner providing purchasing contract access for Leiters' products through its member healthcare organizations.
• Angels for ChangeminorStrategic or Co-development PartnerAngels for Change is a nonprofit organization focused on drug shortage solutions. Leiters is listed as an industry partner, with Marc Mullen (CCO) featured in EDSA member spotlights. Leiters participates in the End Drug Shortage Alliance (EDSA).
• Besse MedicalminorChannel Partner/ Reseller/ DistributorOphthalmic products are available through Besse Medical's inventory management systems, CubixxMD and PODIS Plus, extending distribution reach to eye care practices.
• EyeConnect InternationalminorChannel Partner/ Reseller/ DistributorEyeConnect International is listed as an industry partner, potentially providing integration or distribution for ophthalmic products.
• Summa HealthcoreStrategic or Co-development PartnerSumma Health collaborated with Leiters for over two years developing a compounded nerve block agent. The partnership between Summa Health's anesthesia and pharmacy departments and Leiters was published as a clinical case study, demonstrating the opioid-free pain management protocol using Leiters' preparations within an ERAS framework.
• US RetinaminorChannel Partner/ Reseller/ DistributorUS Retina is a GPO partner providing purchasing contract access for ophthalmic products to member retina practices and surgery centers.
• Eye Pro GPOminorChannel Partner/ Reseller/ DistributorEye Pro GPO is a specialized group purchasing organization for eye care, providing purchasing contract access for Leiters' ophthalmic products.
• Capis (HealthTrust)minorChannel Partner/ Reseller/ DistributorCapis (HealthTrust aggregation solutions) is a GPO partner providing purchasing aggregation and contract access for Leiters' products.

Scale indicators5 records

Recent moves5 records

Expansion highlights6 records

Direct peers

• QuVa Pharma: QuVa Pharma is a leading FDA-registered 503B outsourcing facility providing compounded sterile preparations to hospitals and health systems. Backed by Bain Capital, it is the closest direct competitor to Leiters in the 503B hospital and ophthalmology compounding space.
• Revelation Pharma: Revelation Pharma is an FDA-registered 503B outsourcing facility specializing in sterile compounding for hospitals, surgery centers, and ophthalmology clinics. Backed by Osceola Capital, it competes head-to-head with Leiters across hospital, ophthalmology, and pain management product lines.
• Olympia Pharmaceuticals: Olympia Pharmaceuticals operates as a 503B outsourcing facility offering compounded sterile preparations nationwide. Its hospital and ophthalmology product lines, GPO contracts, and focus on quality/compliance make it a directly comparable peer to Leiters.
• Premier Pharmacy Labs: Premier Pharmacy Labs is a 503B outsourcing facility providing sterile compounded preparations to hospitals and health systems. It serves the same customer base as Leiters and competes on similar product categories including pre-filled syringes and IV bags.
• Edge Pharma: Edge Pharma is an FDA-registered 503B outsourcing facility offering compounded sterile preparations including pre-filled syringes and IV bags to hospitals. Its product portfolio and regulatory positioning closely overlap with Leiters' hospital services.
• Cantrell Drug Company: Cantrell Drug Company is a 503B outsourcing facility providing compounded sterile preparations with a national footprint. It competes with Leiters in hospital sterile compounding and shares similar FDA-registered cGMP operations.

Emerging players

• Avanos Medical: Avanos Medical is the manufacturer of the ON-Q Pain Relief System for which Leiters offers a preferred pharmacy fill service. While Avanos is primarily a device company, its ON-Q franchise intersects with Leiters' pain management portfolio and channels compounded anesthetic fills to hospitals.
• AmerisourceBergen: AmerisourceBergen is one of the largest pharmaceutical distributors in the US and a GPO/buying group partner of Leiters. While primarily a wholesaler, its distribution scale and customer relationships overlap with Leiters' downstream hospital channels.

Broad incumbents

• Cardinal Health: Cardinal Health is a major pharmaceutical distributor and healthcare services company. While it does not operate as a 503B outsourcer in the same way, it competes broadly in pharmaceutical distribution and hospital supply, and Leiters' CCO Marc Mullen previously held SVP/GM roles there.
• Walgreens / Option Care: Walgreens operates pharmacy and specialty/infusion services (including Option Care) and has been a major employer of pharmacy leadership (Dr. Barbara Knightly held prior roles at Walgreens/Option Care). While broader in scope, its 503A and specialty pharmacy operations partially overlap with Leiters' hospital and specialty compounding services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/Leiters
• YouTubeyoutube.com/channel/UCpLWG6lvwOwXBTon13NeWwQ
• Facebookfacebook.com/LeitersHealth
• LinkedInlinkedin.com/company/leiters

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds2 records

Investors2 records

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 Leiters