Leiters
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.
- Company typePrivate
- Founded1926
- HeadquartersEnglewood, United States
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
Leiters firmographics
Firmographics- 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
Leiters industry classification
Industry- 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
Where Leiters is headquartered
LocationHeadquarters
- HQ city
- Englewood
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Leiters business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Operations, Supply Chain, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- 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
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Volume-based committed pricing tiers |
Go-to-market motion2 records
Distribution channels5 records
Marketing channels7 records
Leiters product offering
Product offeringCore 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
Companies that use Leiters
Customer profileNamed customers1 record
Segments4 records
Ideal customer profiles2 records
Leiters technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
Feature4 records
Leiters partnerships and signals
Strategic signalPartnerships
Twelve partnerships are on record, tiered core and minor.
- Avanos MedicalcoreLeiters 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.
- VizientcoreVizient is a GPO partner and also listed as an industry partner. Leiters participates in Vizient's drug shortages initiatives and GPO purchasing contracts.
- AmerisourceBergencoreAmerisourceBergen is a GPO partner providing distribution and purchasing contract access for Leiters' products to member healthcare facilities.
- HealthTrust PGcoreHealthTrust is a GPO partner offering purchasing contract access for Leiters' compounded sterile preparations to member hospitals and health systems.
- PremiercorePremier is a GPO partner providing purchasing contract access for Leiters' products through its member healthcare organizations.
- Angels for ChangeminorAngels 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 MedicalminorOphthalmic products are available through Besse Medical's inventory management systems, CubixxMD and PODIS Plus, extending distribution reach to eye care practices.
- EyeConnect InternationalminorEyeConnect International is listed as an industry partner, potentially providing integration or distribution for ophthalmic products.
- Summa HealthcoreSumma 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 RetinaminorUS Retina is a GPO partner providing purchasing contract access for ophthalmic products to member retina practices and surgery centers.
- Eye Pro GPOminorEye Pro GPO is a specialized group purchasing organization for eye care, providing purchasing contract access for Leiters' ophthalmic products.
- Capis (HealthTrust)minorCapis (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
Leiters competitors and assessment
Company assessmentDirect 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
Leiters social profiles
Digital presenceLeiters compliance and trust
Trust signalCompliance2 records
Leiters financial estimates
Financial estimateRevenue estimate
Valuation estimate
Leiters leadership team
Management profileNumber of profiles
Profiles15 records
Leiters funding detail
Funding detailFunding overview
Funding rounds2 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Leiters M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Leiters
What does Leiters do?
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.
Is Leiters a public or private company?
Leiters is a private company. It is classified as private equity controlled and is currently operating.
When was Leiters founded?
Leiters was founded in 1926. It employs 101 to 250 people.
Where is Leiters based?
Leiters is headquartered in Englewood, United States, in the North America region.
How does Leiters make money?
One revenue line is on record: compounded Sterile Preparations (503B).
Who are Leiters's main competitors?
Direct peers on record are QuVa Pharma, Revelation Pharma, Olympia Pharmaceuticals, Premier Pharmacy Labs, Edge Pharma and Cantrell Drug Company. Emerging players are Avanos Medical and AmerisourceBergen. Broad incumbents are Cardinal Health and Walgreens / Option Care.
Does Leiters have an API?
No public API is recorded for Leiters.
What industry is Leiters in?
Leiters's product category is Sterile Pharmaceutical Compounding (503B Outsourcing). Its primary akta.pro industry code is HLAIAJAB, Specialty Pharmaceutical Distributors, with a secondary code of HLAIAJAN, Controlled Substances & Compliance-Focused Pharmaceutical Distributors. Its NAICS code is 424210 and its SIC code is 5122.