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Over-The-Counter (OTC)

Powering Go-To Products

Our Innovate — Formulate — Create approach has been the catalyst for some of the most well-recognized Filed NDA and Monographed OTC products on the market, including globally known brands of novel skin therapeutics, topical analgesics, burn/itch, nasal sprays, anti-inflammatory treatments, antacids, hemorrhoid care, baby care, sunscreens and more. We've developed and executed leading-edge solutions for customers in the areas of dermatologicals, cough & cold, disinfection, oral care, skin protection, anti-fungals, wounded skin, medicated hair, first aid, premium skincare and clinical professional applications — though this is just our track record to date. We have the expertise, infrastructure and fervor to tackle so much more.

Whether you have an existing product line you would like to expand with highly differentiated solutions, or are starting from scratch, we’re not just up for the challenge — we live for it. Bring us your challenge and together let’s build your patients’ next go-to product.


Case Study  | Over-The-Counter

Reclaiming Product And Market Stability In Therapeutic Powder Sprays

The Challenge

The brand owner of a product intended to treat damaged ulcerated skin utilizing a therapeutic powder spray combination had been working, unsuccessfully, to commercialize a product it desired to bring to the market. After several failed introductions and two product recalls, the brand owner called an all-hands meeting at the contract manufacturing organization, which included component and raw material suppliers. The agenda was to fix this issue once and for all by whatever means necessary.

The 'Formulated' Solution

During the meeting, one representative who had worked closely with us in the past recommended the brand owner contact Formulated Solutions — a different breed of CDMO — for help. Given our long history of successfully addressing difficult-to-formulate and difficult-to-fill products, the brand owner took the representative’s suggestion and called us directly from the parking lot to explain the issue. Within a week, the brand owner was in Largo, Florida, meeting with our team of experts to discuss potential options. Within six weeks, the product had been successfully redesigned, along with the introduction of a first-in-class “green” non-flammable propellant system, paving the way for a successful re-induction.


Ratings from Healthcare Employees (N=56)


Nursing home studies were performed to study the impact of this breakthrough form. The results were remarkable:

  • Significant increase in patient and caregiver satisfaction
  • Overall decrease in application cost per patient
  • Significant and unexpected decrease in cross contamination-related infections
  • Increased consistency of active dispersion and product experience
  • Elimination of product clogging
  • Three patent applications submitted; two granted and currently active
Formulated Solutions is unique in its position relative to other contract manufacturers.

Technical Lead, Leading Global Pharma Company


Case Study  | Over-The-Counter

From Standalone SKU To Multiple Top 10 Offerings: Product Expansion Drives Brand Growth

The Challenge

Formulated Solutions was introduced to a global healthcare firm that had been hugely successful in its core categories around the world. As the company grew its global footprint, it enjoyed rapid adoption of its products, including a single SKU that was introduced to the U.S. market and quickly became the number one item in its category. Success was certainly sweet, but future growth potential was limited with only a single item on the shelf.

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The 'Formulated' Solution

After a meeting to discuss the company’s needs, insights, and long-term ambitions, the Formulated Solutions team went to work experimenting and prototyping new solutions that would be highly incremental to the existing brand, with the goal of minimizing market cannibalism of its own top-selling SKU. Today, in partnership with Formulated Solutions, the brand enjoys an enhanced retail footprint, increased brand recognition, and can regularly claim three of the top 10 spots in its category, including steadfast preservation of its claim as the number one-selling SKU in the product category.

Formulated Solutions is a unique extension of our product development organization.

Associate Director R&D, Leading Global Pharma Company


Case Study  | Over-The-Counter

Consumer-Centric Approach Drives Application Innovation In Therapeutic Skincare

The Challenge

We were approached by the open innovation team of a global healthcare company that was looking for a partner to co-develop a highly innovative approach to therapeutic skincare with the goal of enhancing the product application experience and increasing usage compliance. The company had been working for years on a technical solution but was stuck, and the program was on the verge of being permanently cancelled.

The 'Formulated' Solution

Within just 10 days of contacting Formulated Solutions, samples were delivered to the customer who described them as “exactly what we were looking for.” Following a successful U.S. launch, the corporate team was awarded the highest level of recognition for project innovation and went on to win several industry awards. During multiple promotional periods, the product was recognized as the number one or number two best-selling new product in the personal care category, and the company is already leveraging its success in the U.S. as is it expands distribution to a global scale. Multiple U.S. and global patents are pending.

Formulated Solutions is an innovation partner that brings high-value concepts to our organization.

Director Product Supply, Therapeutic Skincare Company