What Formulated Solutions does

Formulated Solutions is a US-based, non-sterile contract development and manufacturing organization (CDMO) founded in 1999 and headquartered in Largo, Florida. The company provides end-to-end services for pharmaceutical, over-the-counter (OTC), medical device, and consumer healthcare brand owners, spanning formulation and analytical development, regulatory affairs, cGMP manufacturing, and packaging. Its product portfolio covers topical creams, gels and ointments, nasal sprays, oral dose liquids, aerosols, bag-on-valve systems, and high-solid powder sprays across Rx, OTC, personal care, and FDA Class 1/2 medical device categories.

The company's technology base rests on three proprietary delivery platforms—eN₂fused™ (whipped microbubble delivery), cryO₂fused® (cryogenic cooling delivery), and ZnOSpray™ (high-solid powder spray)—complemented by container closure systems and high-speed production lines reaching 185–200 units per minute on metered dose nasal sprays. Operating capacity exceeds 650 million units annually across more than 800,000 sq ft of combined cGMP manufacturing and warehousing, anchored by a 220,000 sq ft flagship in Largo, FL and a 455,000 sq ft secondary site in Cleveland, TN acquired in 2023. The company is regulated by FDA and 16 additional global authorities and holds ISO 9001, ISO 13485, ISO 22716, ISO 14001, and ISO 45001 certifications.

Formulated Solutions generates revenue on a fee-for-service contract manufacturing basis, with commercial programs typically requiring minimum order quantities of 50,000–75,000 units per SKU and scaling to tens of millions of units annually under multi-year agreements. The company sells exclusively through a B2B enterprise model targeting brand owners, with go-to-market driven by direct field sales (led by a Chief Commercial Officer and regional representatives) supplemented by industry trade shows (BIO, CPHI, Cosmoprof), thought leadership webinars, and content marketing. Customers include seven of the world's top 12 consumer healthcare companies, and products reach more than 45 countries. The company has been controlled by Linden Capital Partners since 2021, when founder Eric Dann sold a controlling share while retaining a board seat.

Name

Formulated Solutions

Legal name

Formulated Solutions, LLC

Website

https://formulatedsolutions.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Formulated Solutions is a US-based non-sterile CDMO providing end-to-end formulation development, cGMP manufacturing, and packaging services for pharmaceutical, OTC, medical device, and consumer healthcare brand owners across two facilities totaling 800,000+ sq ft.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Manufacturing

NAICS

Pharmaceutical Preparation Manufacturing (325412), Medical Equipment and Supplies Manufacturing (3391)

SIC

Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

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

akta.pro secondary industries

Packaging, Labeling & Serialization (Clinical/Commercial) CDMO (HLAGABAJ), Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

Keywords

• Contract development manufacturing
• Pharmaceutical CDMO services
• CGMP contract manufacturing
• Aerosol drug delivery
• Pressurized packaging manufacturing

Headquarters

HQ city

Largo

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Contract Manufacturing Services: Formulated Solutions generates revenue through fee-for-service contract manufacturing agreements, where it develops and manufactures pharmaceutical, OTC, medical device, and consumer healthcare products on behalf of brand owners (marketing partners). Services span the full product lifecycle from formulation development and analytical testing through commercial manufacturing and packaging. Revenue is driven by volume of units produced, complexity of formulations, and breadth of services contracted.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Formulated Solutions is a full-service Contract Development and Manufacturing Organization (CDMO) providing end-to-end non-sterile pharmaceutical, OTC, medical device, and consumer healthcare product development and manufacturing on behalf of brand owner marketing partners. Services span formulation and analytical development, regulatory affairs, cGMP commercial manufacturing, and packaging across two U.S. facilities (Largo, FL and Cleveland, TN), supported by proprietary delivery platforms (eN₂fused™, cryO₂fused®, ZnOSpray™) and container closure systems including bag-on-valve, aerosol, metered dose nasal spray, and airless containers.

Product overview

Formulated Solutions is a Contract Development and Manufacturing Organization (CDMO) providing end-to-end pharmaceutical and consumer healthcare product development and manufacturing services. The company operates two US manufacturing facilities (Largo, FL and Cleveland, TN) totaling over 800,000 sq ft. Core offerings include proprietary delivery technologies (eN₂fused™ whipped delivery, cryO2fused® cryogenic delivery, ZnOSpray™ high-solid powder spray), container closure systems (bag-on-valve, aerosols, metered dose nasal sprays, airless containers), technology platforms (semi-solid and liquid manufacturing), and comprehensive services (formulation development, analytical development, manufacturing, regulatory affairs, and packaging). The company serves Rx therapeutics, OTC, personal care, and medical device market segments with cGMP production capabilities.

Differentiator

Problem solved

Functional benefit

Brands

• eN₂fused™: Proprietary whipped delivery platform that infuses formulations with compressed gas microbubbles, creating whipped, aerated texture for creams, lotions and ointments.
• cryO₂fused®
• ZnOSpray™

Products and services

• eN₂fused™ Whipped Delivery Platform Proprietary whipped delivery technology that infuses formulations with compressed gas microbubbles to create whipped, aerated textures for creams, lotions, and ointments, enabling differentiated sensory experiences for pharmaceutical and consumer healthcare brand owners.
• cryO₂fused® Cryogenic Delivery Platform Patented cryogenic platform that creates an intense cooling sensation on the skin using cryogenically active micro-bubbles that burst on contact, usable in foams and sprays for skincare, pain relief, and personal care applications.
• ZnOSpray™ High Solid Powder Spray Platform Proprietary high-solid powder spray platform that reliably delivers high-solid-content powders (e.g., zinc oxide) without clogging or agglomeration, with applications in incontinence-associated dermatitis treatments, dry shampoos, and antifungal foot sprays.
• Bag-on-Valve (BoV) Container System Pressurized container system featuring a multi-layer laminate bag hermetically sealed inside a can with compressed gas, providing 360° dispensing, product protection from oxygen, and >99% evacuation rate.
• Aerosol Delivery Systems Pressurized aerosol delivery systems integrating can, valve, dip tube, actuator, formula concentrate, and propellant components for pharmaceutical and consumer health applications.
• Metered Dose Nasal Spray (MDNS) Systems Precision nasal delivery system providing pinpoint therapeutic delivery to nasal mucosa with controlled dosing for localized treatment, produced on a 9,000 sq ft high-speed suite capable of 185-200 units per minute.
• Airless Container Systems Vacuum-powered airless packaging system with rising barrier plate that prevents air intrusion, providing contamination protection, precise dosage, and >99% product evacuation for medical devices and NDA products.
• Semi-Solid Manufacturing Platform Development and manufacturing platform for semi-solid products including creams, gels, lotions, and ointments, with capabilities for high viscosity, high alcohol, and flammable formulations across 11 high-speed tube filling lines.
• Liquid Technologies Manufacturing Platform Master liquid product development and manufacturing platform for pharmaceuticals, OTC drugs, personal care, and cosmetics, with capabilities including tube filling (laminate, aluminum, monolayer), rollerballs, nasal spray pumps, bottles, jars, and pumps.
• Formulation & Process Development Comprehensive formulation and process development services for aerosols, liquids, gels, creams, lotions, nasal sprays, and oral dose liquids, using an integrated QbD approach with scalable manufacturing design.
• Analytical Development Services Full-service analytical method development, verification, validation, and transfers, including chromatography (LC, GC, GC-MS, FTIR), product characterization, and atomic absorption spectrometry.
• cGMP Commercial Manufacturing Full-turnkey cGMP commercial manufacturing with capabilities including water-based, anhydrous, and alcohol blending, pressurized bag-on-valve and aerosol packaging, tube filling, and metered dose nasal spray production, with flexible batch sizes from 25 to 4,000 gallons across both Largo, FL and Cleveland, TN facilities.
• Regulatory Affairs Services Regulatory strategy and compliance services including CMC management, CTD development, FDA submissions (IND/NDA), and support for OTC, Rx, medical device, and global regulatory pathways.
• Packaging Engineering and Manufacturing Packaging engineering and manufacturing services including aerosol innovations, bag-on-valve, pressurized powder sprays, nasal delivery, and liquid/semi-solid filling in bottles, jars, and tubes, with modular production lines for rapid reconfiguration.

Quantifiable outcome

• Over 650 product success stories delivered across pharmaceutical and consumer healthcare markets
• +4 more outcomes

Named customers1 record

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

Scale indicators11 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Catalent: Global CDMO offering formulation, development, and manufacturing services across oral, sterile injectable, biologics, and consumer health formats. Most directly comparable as a full-service pharmaceutical and consumer healthcare CDMO competing for the same brand-owner programs.
• West Pharmaceutical Services: Specializes in primary packaging, drug delivery systems, and contract manufacturing for injectables and consumer health. Comparable through its expertise in container closure systems (analogous to Formulated Solutions' bag-on-valve, metered dose, and airless container offerings) and its CDMO services for pharma and consumer health customers.
• Aptar Pharma: Provides drug delivery systems, dispensing solutions, and contract development services for pharma, OTC, and personal care. Direct comparable through nasal spray pumps, aerosol valves, and bag-on-valve technologies that overlap with Formulated Solutions' container closure and pressurized packaging capabilities.
• Kindeva Drug Delivery: Global CDMO focused on inhalation, transdermal, and intradermal drug delivery, plus injectable manufacturing. Overlaps with Formulated Solutions in pressurized metered dose and topical drug delivery for pharma and consumer health brand owners.
• Recipharm: European-headquartered CDMO offering development and manufacturing across solid, semi-solid, and sterile dosage forms. Comparable as a multi-site CDMO serving pharma and consumer health customers with formulation, analytical, and commercial manufacturing services.
• PCI Pharma Services: Global CDMO providing drug development, manufacturing, and packaging services across solid dose, sterile, and clinical supply. Comparable in offering integrated services from development through commercial packaging to pharmaceutical and consumer health brand owners.
• Halo Pharma: U.S.-based CDMO focused on small-molecule oral solids, liquids, and semi-solids for pediatric, psychiatric, and consumer health products. Closely comparable in scale and specialty dosage form focus, including topicals and liquids, serving brand-owner customers.
• Nephron Pharmaceuticals: Large U.S. CDMO and generic manufacturer with FDA-approved facilities producing inhalation, ophthalmic, and liquid dosage forms. Comparable through its consumer healthcare manufacturing scale and its pressurized/aerosol product capabilities.
• Coating Place: U.S. contract manufacturer specializing in Wurster coating, hot-melt extrusion, and modified-release oral dose forms. Comparable as a smaller, specialty U.S. CDMO with proprietary processing capabilities serving pharma brand owners.

Broad incumbents

• Aenova Group: European-headquartered CDMO offering development and manufacturing for pharma, dietary supplements, and consumer health across solid, semi-solid, and liquid dosage forms. Comparable as a broader incumbent with overlapping topical, liquid, and consumer health CDMO services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/formulated-solutions

Compliance19 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds1 record

Investors1 record

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 Formulated Solutions