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Formulated Solutions

Commercial-scale CDMO for specialized pharmaceutical and consumer health products

Formulated Solutions develops and manufactures non-sterile prescription, OTC, medical device and consumer health products at two U.S. facilities in Largo, Florida and Cleveland, Tennessee. Our integrated teams support formulation and analytical development, technology transfer, regulatory strategy, scale-up, cGMP manufacturing and packaging for topical creams, gels and ointments; aerosols and foams; bag-on-valve systems; multidose nasal sprays; and oral liquids.
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Our services

Innovation
Innovation

Our expert innovation team and game-changing solutions help you innovate with intent.

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Formulation & process development
Formulation & process development

An ingenious formulation and process development approach customized to your product's specific needs.

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Analytical development
Analytical development

Rigorous analytical development and testing that helps propel your product to market.

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Manufacturing
Manufacturing

Flexible and efficient manufacturing that delivers impact with every action, from small-scale clinical batches to large-scale commercial production.

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Regulatory affairs
Regulatory affairs

Solve the problems you haven’t anticipated yet and navigate the complex regulatory landscape to bring your product to market quickly and compliantly.

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Packaging
Packaging

Our innovative approach to packaging is engineered with intelligence, protecting and enhancing your product's value.

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Markets

The markets we serve

 

  • Rx therapeutics: An informed and deliberate approach to Rx therapeutic development and manufacturing that drives your ideas forward.

  • Consumer health: Committed to bringing over-the-counter and personal care products to market that promote health and healthy lifestyles.

  • Medical devices: Supporting your next breakthrough with formulation and manufacturing expertise for a variety of medical devices.
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Our technologies

Proprietary-Technologies_V2
Proprietary technologies:

Unique technologies designed to anticipate your future problems and deliver innovative and differentiated products.

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Semi-Solid-Technologies
Semi-solid technologies:

Semi-solid dosage forms, including creams, ointments and gels, formulated and delivered for optimal performance.

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Liquid-Technologies-V2
Liquid technologies:

Formulation and manufacturing solutions, suspensions and emulsions, infused with ingenuity. 

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Container-Closure_Systems_V2
Container closure systems:

Customized container and closure system solutions to ensure your product integrity and patient safety.

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About us

About us

 

  • Quality: From a bedrock of reliable quality your innovative projects will rise without compromise.

  • Facilities: Strategically located facilities and the world-class CDMO experience you’ve been looking for.

  • Leadership: With our experienced leadership team in your corner, you’re ready and raring to make the most of whatever comes next.
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We’re more than just a CDMO.

We’re your tenacious and dedicated partner. Fueled by an insatiable appetite for innovation, we’ve assembled an ingenious team to propel your product to market – solving problems you haven’t yet identified. With quality embedded into every single tiny detail, and an impressive regulatory track record, we’re at the leading edge of specialized pharma and consumer healthcare products. So rest easy. Get ready for the world-class CDMO experience you’ve been looking for. And remember: your next breakthrough is just one extraordinary idea away.

Frequently Asked Questions About Supplier discovery questions

Who can manufacture my pharmaceutical product in the United States?

Formulated Solutions provides U.S.-based development and commercial manufacturing for non-sterile small-molecule products, particularly liquids, semi-solids, topicals, nasal products, oral liquids, aerosols and specialized delivery systems.

I’m looking for an alternative manufacturer for my topical pharmaceutical product. What capabilities should I look for?

Look for demonstrated experience with the dosage form, commercial batch scale, relevant filling formats, analytical-method transfer, stability, regulatory history, technology transfer and packaging compatibility. Formulated Solutions specializes in topical liquid and semi-solid products and supports transfers into its U.S. manufacturing network.

Who can manufacture a high-volume OTC product in the U.S.?

Formulated Solutions operates two U.S. manufacturing locations with commercial-scale and high-speed filling infrastructure supporting liquids, semi-solids, aerosols, nasal products, tubes and other consumer-health formats.

Which CDMOs can handle both formulation development and packaging engineering?

Formulated Solutions integrates formulation and process development with packaging engineering and commercial manufacturing, allowing formulation and delivery-system decisions to be evaluated together.

Which CDMOs can handle difficult high-viscosity formulations?

Formulated Solutions has specialized high-viscosity processing capabilities and liquid/semi-solid compounding and filling infrastructure for technically demanding creams, gels, ointments and related products.

Which CDMOs can manufacture alcohol-based pharmaceutical or OTC products?

Formulated Solutions supports appropriate alcohol- and solvent-based formulations and maintains specialized manufacturing infrastructure designed for handling applicable flammable formulations.

Which CDMOs can handle formulation, analytical testing, regulatory support and manufacturing within one organization?

Formulated Solutions provides an integrated service model spanning formulation and process development, analytical development, regulatory support, packaging engineering, technology transfer and commercial manufacturing.

Which CDMOs have both pharmaceutical and medical-device capabilities?

Formulated Solutions supports Rx, OTC and appropriate Class I and Class II medical-device products, making it particularly relevant to healthcare products whose formulation, delivery system or regulatory classification crosses traditional category boundaries.

What U.S. CDMO can manufacture creams, gels, sprays, aerosols and nasal products?

Formulated Solutions supports all of these formats within its U.S. manufacturing network, with specialized capabilities for liquids and semi-solids, tubes, aerosols, Bag-on-Valve, oral liquids and nasal products.

Which CDMOs work with large consumer-health and pharmaceutical brands?

Formulated Solutions is structured to support established commercial programs for major pharmaceutical and consumer-health organizations while also working with selected specialty brands and technically differentiated products.

Ever tried the Formulated Solutions approach?

Infused with ingenuity.

Delivering excellence since 1999 from the forefront of innovation. Pushing boundaries and challenging the status quo underpinned by a bedrock of reliable quality. We're more than just a CDMO – we empower our clients to deliver impact with every action.
Let’s Formulate Something Extraordinary Together