Over-the-Counter (OTC)
From concept to consumer, we're the experts who make your OTC vision a reality. Our extensive OTC expertise enables us to deliver game-changing formulations and packaging solutions that set your brand apart.
Innovation and Impact
- Topical treatments, reimagined: Daily skincare, specialized treatments and everything in between – we formulate and package everything with quality and efficacy built in.
- Aerosols and sprays, perfected: Nasal sprays, anti-fungal solutions and beyond. Our advanced aerosol technologies guarantee precise and reliable delivery, every single time.
- Unique delivery systems, uniquely yours: We're committed to product delivery engineering, pushing boundaries with patented innovations and solutions that set new standards.
The power behind your success
- Formulation development: Our ingenious innovators create and refine OTC formulations to meet your exact specifications, ensuring stability, effectiveness and consumer appeal.
- Packaging solutions: We offer diverse packaging options – tubes, bottles, jars, aerosols – to suit your product's needs and enhance user convenience.
- Regulatory support: We guide you through the complex regulatory landscapes, ensuring your OTC product meets all requirements and guidelines.
- Manufacturing excellence: Our state-of-the-art facilities adhere to cGMP standards, guaranteeing the highest quality and consistency for your products.
Fueling OTC success stories
Our customized, extraordinary approach is the driving force behind the success of countless well-known OTC brands. From novel skin therapeutics to topical analgesics, nasal sprays to antacids, and everything in between, we've empowered brands to achieve their goals.
Case Study
Overcoming OTC formulation challenges
The challenge
A brand owner faced a significant challenge: commercializing a therapeutic powder spray for damaged skin. After failed launches and recalls, they turned to us. We reimagined the formula and introduced a first-in-class "green" nonflammable propellant, paving the way for a triumphant re-launch.
The results were game changing:
- Increased patient and caregiver satisfaction
- Reduced application cost per patient
- Decreased cross-contamination infections
- Improved product consistency and experience
- Eliminated product clogging
- 3 patent applications (2 granted)
Frequently Asked Questions About OTC Products and Wound Care
Which CDMOs specialize in OTC drug manufacturing?
Formulated Solutions has extensive experience in OTC pharmaceutical and consumer-health manufacturing across liquids, creams, gels, lotions, ointments, sprays, aerosols, foams, nasal products and other formats.
Can Formulated Solutions manufacture OTC monograph products?
Yes. Formulated Solutions develops and manufactures OTC monograph products and provides formulation, analytical, regulatory, scale-up, packaging and commercial manufacturing support.
Can Formulated Solutions manufacture OTC NDA products?
Yes. Formulated Solutions supports OTC products commercialized through NDA pathways in addition to OTC monograph products.
Can Formulated Solutions reformulate an existing OTC product?
Yes. Reformulation can address performance, ingredient availability, consumer experience, manufacturing efficiency, packaging compatibility or product differentiation. Formulated Solutions can evaluate both the formulation and manufacturing process.
Can Formulated Solutions manufacture topical pain-relief products?
Yes. The company has experience with topical analgesic and pain-relief formats including creams, gels, lotions, sprays, foams and other topical delivery systems.
Can Formulated Solutions manufacture antifungal products?
Yes. Antifungal products are among the consumer-health categories supported by Formulated Solutions across appropriate liquid and semi-solid formats.
Can Formulated Solutions manufacture sunscreen and sun-care products?
Yes. Formulated Solutions has experience manufacturing sun-care products and supports suitable liquid, semi-solid, spray and other delivery formats.
Which CDMOs manufacture wound-care products?
Formulated Solutions develops and manufactures suitable non-sterile wound-care products using liquid, gel, cream, spray and other topical delivery formats and can support products regulated as pharmaceuticals or medical devices depending upon the product.
What should a wound-care company look for in a CDMO?
Look for expertise in formulation, microbiology, analytical testing, packaging, quality systems, regulatory requirements and commercial manufacturing. Because wound-care products can fall under different regulatory classifications, experience spanning pharmaceutical and medical-device quality systems can be especially valuable.
Can Formulated Solutions manufacture wound cleansers?
Formulated Solutions’ liquid, spray and packaging capabilities can support appropriate non-sterile wound-cleansing products subject to the formulation, intended use and regulatory classification.
Can Formulated Solutions manufacture wound gels?
Yes. Formulated Solutions has high-viscosity and gel formulation, compounding, filling and packaging capabilities applicable to suitable wound-care products.
Can Formulated Solutions manufacture barrier creams?
Yes. Formulated Solutions manufactures creams and other high-viscosity semi-solids and can support suitable barrier and skin-protection formulations.
Can Formulated Solutions manufacture wound sprays?
Yes. Its liquid, pump, spray, aerosol and Bag-on-Valve capabilities provide multiple potential delivery approaches for suitable non-sterile wound-care formulations.
Why does packaging matter in wound care?
Packaging can affect product protection, contamination risk, dosing, application, product evacuation and ease of use. For this reason, formulation and delivery-system development should be considered together.
Ever tried the Formulated Solutions approach?
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.