Bennett Pharmaceuticals Of America

What Bennett Pharmaceuticals Of America does

Bennett Pharmaceuticals of America, LLC is a privately held FDA-registered 503B outsourcing facility that develops and manufactures proprietary needle-free topical anesthetic medications. Founded in 2022 and headquartered in Long Lake, Minnesota, with primary operations in Hudson, Wisconsin, the company operates under full cGMP compliance and serves doctors, hospitals, dentists, and veterinarians across the United States through a vertical segmentation approach. Bennett is one of only 74 FDA-registered 503B manufacturing facilities in the country, which grants it the ability to compound products on the bulk substance list and drug shortage list under federal outsourcing facility authority.

The company's product portfolio centers on three proprietary lines. Orlicaine is a patented topical anesthetic (gel and liquid viscosities, available in mint and bubblegum flavors) using Tetracaine HCL, Bupivacaine HCL, and Phenylephrine HCL, with onset in seconds and a 30-90 minute duration, targeting dental procedures including pediatric restorations, SRP, frenectomies, and implant crown seating. STAT is a tetracaine-based sterile anesthetic available in gel, spray (50 doses of 100 microliters each), and liquid formats, used in emergency medicine, wound care, suturing, OBGYN, sports medicine, and urology. MaxMist is a proprietary single-use, barcode-ready intranasal delivery system with separate Dental (pulpal anesthesia of teeth 4-12 via ASA/MSA block) and ENT (nasal cavity anesthesia) variants. Formulation and method patents are filed or pending for all three lines, providing up to 20 years of exclusivity from provisional filing date.

Revenue is generated primarily through one-time direct sales of these pharmaceutical products to licensed healthcare professionals via an e-commerce storefront (shop.bennett-pharma.com), email-based ordering for medical facilities, and wholesale distribution to GPOs and DSOs. The GTM motion is sales-led, supported by industry conference presence, virtual lunch-and-learn sessions, and a Dental Evaluation Kit used to drive trial and conversion. A reported 70%+ customer return rate, materially above the 40% industry benchmark, indicates strong workflow integration once products are adopted. Leadership includes CEO Jim Mulvahill (20 years of FDA experience), President Kathryn Burgess, Medical Director Dr. Michael Smilanich (40 years restorative dentistry), Director of Quality Dr. Alyssa Real, and Pharmacist-in-Charge Dr. Megan Adelman.

Name

Bennett Pharmaceuticals Of America

Legal name

Bennett Pharmaceuticals of America, LLC

Website

https://bennett-pharma.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

Bennett Pharmaceuticals of America is a privately held FDA-registered 503B outsourcing facility that develops and manufactures proprietary needle-free topical anesthetic medications (Orlicaine, STAT, MaxMist) for dental, medical, and veterinary professionals across the United States, operating under full cGMP compliance.

Ownership category

akta.pro rank

Product category

Compounded Topical Anesthetic Pharmaceuticals (503B Outsourcing)

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro industry

PRIMARYHLAFALAE

Compounding Pharmacies (Sterile/Non-Sterile)

Healthcare & Life Sciences/Healthcare Providers & Systems/Pharmacy & Medication Management Services

SECONDARYHLAHAIAK

Nasal Drug Delivery Devices (Sprays/Powder Devices)

Healthcare & Life Sciences/Medical Devices & Diagnostics/Drug Delivery Devices (Injectors, Pumps, Inhalers)

SECONDARYHLAIAAAN

Pain Management & Anesthesiology Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Branded (Innovator) Pharmaceuticals

Keywords

• Topical anesthetics
• 503B outsourcing
• Compounded pharmaceuticals
• Intranasal anesthesia
• CGMP manufacturing

Headquarters

HQ city

Long Lake

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Sales: Bennett generates revenue through sale of proprietary topical anesthetics (Orlicaine, STAT, MaxMist) and compounded medications from bulk and shortage lists. Products sold directly to healthcare professionals and organizations at wholesale pricing.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Bennett Pharmaceuticals develops and manufactures proprietary, needle-free topical and intranasal anesthetic medications under cGMP-compliant 503B outsourcing facility conditions. Its core product lines comprise Orlicaine (mucosal topical anesthetic gel and liquid for dental procedures), STAT (sterile tetracaine-based gel, spray, and liquid for wound care, suturing, emergency medicine, OBGYN, urology, and ENT), and MaxMist (single-use intranasal delivery system providing pulpal and nasal cavity anesthesia for dental and ENT use).

Product overview

Bennett Pharmaceuticals of America is a federally registered 503B outsourcing facility manufacturing sterile and non-sterile pharmaceutical products. The company produces three proprietary topical anesthetic product lines: Orlicaine (dental/medical topical anesthetic in gel and liquid formulations), STAT (medical topical anesthetic in gel, spray, and liquid formulations), and MaxMist (intranasal anesthesia delivery system for dental and ENT applications). These needle-free anesthetics eliminate injections for many procedures, serving doctors, hospitals, dentists, and veterinarians. Products are produced under FDA oversight with cGMP compliance and full batch testing prior to release.

Differentiator

Problem solved

Functional benefit

Brands

• Orlicaine: Patented topical anesthetic providing temporary pain relief for mucosal tissue, available in gel and liquid formulations. Eliminates the need for injections for many pediatric and dental procedures. Active ingredients include Tetracaine HCL, Bupivacaine HCL, and Phenylephrine HCL.
• STAT
• MaxMist

Products and services

• Orlicaine Gel Patented topical anesthetic gel for mucosal tissue providing temporary pain relief with onset in seconds and 30-90 minute duration; active ingredients include Tetracaine HCL, Bupivacaine HCL, and Phenylephrine HCL. Available in Mint and Bubblegum flavors. Used for pediatric dentistry, implant procedures, frenectomies, and other dental applications where needle-free anesthesia is preferred.
• Orlicaine Liquid Thinner viscosity topical anesthetic liquid for broader mucosal coverage with onset in seconds and 30-90 minute duration; available in Mint flavor. Used for SRP, implant procedures, and general dental applications.
• STAT Gel Tetracaine-based sterile anesthetic gel for mucosal and subdermal tissue, positioned as a replacement for L.E.T. gel in medical procedures including emergency medicine, OBGYN, sports medicine, urology, ENT, and suturing. Quick onset and not effective on skin.
• STAT Spray Tetracaine-based sterile anesthetic spray for wound care, sports medicine, OBGYN, urology, and ED applications. Delivered in a 5ml spray bottle with 50 precisely metered 100-microliter doses for hands-free application.
• STAT Liquid Thinner viscosity liquid formulation of STAT tetracaine-based anesthetic supplied in a 12ml jar with luer-lock adapter cap for precise dosing and application.
• MaxMist Dental Intranasal anesthetic delivery system creating pulpal anesthesia of maxillary arch teeth 4-12 via ASA/MSA block, with anesthesia beginning in seconds and lasting up to 15 minutes with continued profounding effect. Single-use, barcode-ready sprayers; 10 devices per pack.
• MaxMist ENT Intranasal anesthesia delivery system for ENT procedures, formulated to provider preferences for anesthesia of the nasal cavity. Part of a proprietary single-use, barcode-ready container-closure system.
• Dental Evaluation Kit Product evaluation bundle for dental professionals containing MaxMist, Orlicaine Liquid, and Orlicaine Gel, enabling evaluation across multiple procedure types including SRP, cosmetic work, and soft-tissue procedures. A Cosmetic Dental Evaluation Kit variant is also offered at a lower price point.
• 503B Bulk/Shortage List Compounded Products Additional pharmaceutical products compounded from the FDA bulk substance list and drug shortage list. Bennett's 503B outsourcing facility registration enables it to compound and produce drugs on the shortage list for healthcare organizations.

Quantifiable outcome

• 70%+ customer return rate vs. 40% industry standard
• +2 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered minor and core.

• Wisconsin Dental AssociationminorGTM or Marketing Partner · 23 October 2024Bennett participated in Wisconsin Dental Association symposium events and promotional activities including Green Bay Packers ticket giveaways.
• Florida Dental AssociationcoreGTM or Marketing Partner · 14 February 2023Bennett Pharmaceuticals is a proud partner of the Florida Dental Association. Participated in their 2023 Convention in Orlando where dentists were able to evaluate Orlicaine products firsthand.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Septodont: Largest global manufacturer of dental anesthetics, with deep KOL relationships and broad penetration in dental practices and DSOs. Comparable dental anesthesia category but with injectable-focused portfolio versus Bennett's needle-free topical approach.
• PCCA (Professional Compounding Centers of America): Largest US compounding pharmacy support organization, supplying ingredients, equipment, and training to compounding pharmacies. Comparable compounding ecosystem position though operates upstream of finished-product manufacturing.
• Dentsply Sirona: Largest manufacturer of dental products and equipment, including dental anesthetics and consumables sold through DSOs and GPOs. Comparable dental channel and formulary access, but operating at vastly larger scale and broader product breadth.
• BPI Labs (Baxter): Operates 503B outsourcing capacity within Baxter's broader injectable pharmaceuticals portfolio. Comparable 503B manufacturing capability but with substantially larger scale, distribution, and hospital relationships.

Direct peers

• QuVa Pharma: One of the largest FDA-registered 503B outsourcing facilities in the US, producing sterile compounded preparations for hospitals and health systems. Directly comparable to Bennett as a 503B outsourcing manufacturer serving healthcare providers under cGMP compliance.
• Wedgewood Pharmacy: Large compounding pharmacy producing customized medications across human and veterinary verticals. Comparable compounded medication model and multi-vertical (including veterinary) customer approach.
• Fagron: Global leader in pharmaceutical compounding, supplying APIs, excipients, and compounded preparations to pharmacies and veterinarians. Comparable compounding focus across human and animal health verticals.
• SCA Pharmaceuticals: FDA-registered 503B outsourcing facility specializing in sterile admixtures and ready-to-administer injectables for hospitals. Comparable 503B regulatory position, cGMP manufacturing model, and hospital/healthcare provider customer base.
• Central Admixture Pharmacy Services (CAPS): Nationwide network of 503B-registered outsourcing facilities producing sterile admixtures and compounded sterile preparations. Directly comparable 503B operating model and provider customer base.
• Leiters: FDA-registered 503B outsourcing facility producing sterile compounded preparations, including ophthalmic and injectable products. Comparable regulatory status and outsourced hospital/specialty pharmacy customer base.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/bennett-pharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 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 Bennett Pharmaceuticals Of America