Formulated Solutions

Formulated solutions: Partnering with pharma for scalable, consumer-centric innovation

Formulated Solutions (FS) has built a reputation as one of the most innovative and dependable contract development and manufacturing organisations (CDMOs) in the healthcare industry. With nearly one million square feet of advanced production space across two U.S. campuses, FS provides full-spectrum development and manufacturing support for over-the-counter (OTC), medical device, and prescription topical drug programs. For pharmaceutical partners seeking a nimble, U.S.-based CDMO with proven expertise across semisolids, liquids, foams, aerosols, and nasal sprays, FS offers a unique blend of technical depth, scalability, and consumer insight that can accelerate the path from molecule to market.

Why pharma chooses Formulated Solutions

1. Clinical-to-commercial continuity
   FS supports programs from early clinical phases through large-scale commercial supply. This eliminates the need for multiple handoffs and ensures smooth technical transfer, regulatory alignment, and consistent quality. Pharma companies can leverage FS’s infrastructure to scale quickly without the delays and capital expenditure associated with building new in-house facilities.
2. Asset-light model
   In today’s environment, pharma companies face increasing pressure to allocate resources toward R&D while limiting capital expenditure. FS’s “asset-light” model allows partners to access specialised equipment, technical expertise, and redundant manufacturing capacity without the cost of standing up new infrastructure. This provides flexibility and reduces risk while enabling faster entry into competitive therapeutic categories.
3. Broad manufacturing capabilities
   FS offers one of the most diverse topical platforms in the industry, spanning:
   • Aerosols and foams (including proprietary eN₂fused Whipped™ technology)
   • Nasal sprays and inhalation delivery formats
   • Liquids and oral solutions
   • Semisolids, gels, creams, and ointments
     This diversity allows pharma partners to consider multiple dosage formats, life-cycle extensions, and patient-friendly delivery systems under one roof.
4. Regulatory strength and quality systems
   FS operates under five ISO certifications and maintains compliance with rigorous FDA, cGMP, and international standards. The company has successfully supported numerous global launches, managing stability programs, site-specific regulatory filings, and quality oversight that meets or exceeds pharmaceutical expectations.

Strategic advantages for pharma partners

• Redundant manufacturing: With two fully capable U.S. production sites, FS ensures supply chain resilience. For example, tens of millions of antifungal sprays are manufactured annually across both sites, ensuring uninterrupted availability.
• Scalable infrastructure: FS can flex production from tens of thousands of clinical units to tens of millions of commercial units, supporting growth trajectories without interruption.
• Innovation engine: With over 40 patents held by its leadership and a track record of consumer-driven innovation, FS helps pharma brands differentiate through delivery formats that enhance patient adherence and market appeal.

Examples of pharma-relevant capabilities

• Dermatology: FS manufactures topical anaesthetics, antifungals, corticosteroids, and other prescription- and OTC-adjacent dermatology treatments.
• Nasal & respiratory: With dedicated nasal spray filling lines and experience supporting global brands like Afrin and Astepro, FS is well-positioned for Rx nasal programs.
• Pain & inflammation: FS supports aerosol and topical analgesic platforms, including lidocaine, cryotherapy, and counterirritants.
• Speciality delivery: Proprietary technologies like eN₂fused Whipped™ foams provide differentiated sensory profiles and dosing consistency, offering partners novel IP-protected options for lifecycle management.

A partner in market growth

Beyond technical and manufacturing execution, FS positions itself as a true growth partner. By marrying pharmaceutical rigour with consumer market savvy, FS helps pharma companies bridge the gap between clinical efficacy and commercial success. Whether entering competitive generic markets or launching innovative new therapies, FS supports its partners with:

• Cost modelling and COGS optimisation
• Regulatory strategy support
• Consumer-driven packaging and delivery design
• Supply chain efficiency initiatives

This blend of capabilities enables pharma clients to not only launch compliant products but to launch them profitably, with patient-friendly designs that drive brand loyalty and market share.

Forward-looking value for pharma

As pharma companies seek to streamline pipelines, reduce costs, and respond to market volatility, FS provides a model that is both reliable and future-focused. The company’s emphasis on asset-light flexibility, redundant manufacturing, and consumer-centric innovation aligns perfectly with the evolving needs of modern pharma organisations.

In addition, FS is actively investing in IT transformation, advanced analytics, and manufacturing execution systems (MES) to further strengthen traceability, compliance, and operational efficiency. These investments make FS not only a capable CDMO today but a forward-looking partner ready to scale with pharma clients into the next decade.

About Formulated Solutions

Formulated Solutions is more than a manufacturer—it is a partner in bringing pharmaceutical therapies to market with speed, precision, and scale. By offering clinical-to-commercial continuity, a broad range of topical and inhalation capabilities, and a proven track record of delivering for global healthcare leaders, FS stands out as a premier choice for pharma organisations.

For companies seeking to optimise resources, accelerate timelines, and launch differentiated products, Formulated Solutions provides the infrastructure, expertise, and partnership mindset to make it happen.

Let’s Formulate Something Extraordinary Together.