Rx therapeutics
As your trusted Rx therapeutics development and manufacturing partner, we strive to be the driving force behind your next breakthrough product. From initial formulation to final packaging and delivery, we handle it all.
Our expertise spans liquid and semi-solid over-the-counter (OTC) monograph, Rx and new drug application (NDA) manufacturing, including topicals, nasal sprays, and oral dose liquids. We employ game-changing proprietary technologies to achieve results that exceed expectations.
Our Rx solutions:
Always advancing
Backed by decades of experience, world-class facilities and a relentless focus on quality and compliance, we deliver tailored solutions that ensure your product’s success from concept to commercialization.
- End-to-end Rx solutions: We cover the full product lifecycle from formulation and clinical trials to scalable manufacturing and full-scale commercial support.
- Regulatory excellence: Compliance with FDA cGMP, and global regulatory standards ensure safety, quality and approval success.
- Scalable, flexible manufacturing: Our FDA-registered facilities in Largo, FL and Cleveland, TN can handle small clinical batches to full-scale commercial production.
- Proven expertise: Decades of success with complex OTC formulations like aerosols, topicals and nasal sprays provide a seamless transition to Rx.
- Dedicated regulatory affairs: Navigating FDA submissions (IND/NDA) and global approvals with confidence.
- Patient safety first: Rigorous testing and risk management protocols to ensure consistent quality and efficacy.
Tackling healthcare's biggest challenges
We're the trusted partner of pharmaceutical and consumer healthcare companies worldwide, including many of the global leaders. Our mission is clear: To empower our clients to develop game-changing solutions that address unmet patient needs and elevate existing treatments.
- Full-service partner: We manage all stages of your Rx product’s journey, from R&D to post-launch pharmacovigilance.
- Regulatory expertise: Our team simplifies the complexities of FDA approvals and ensures your product meets all compliance milestones.
- Scalable manufacturing: Flexible capacity to grow with your needs, delivering cost-efficiency without compromising on quality.
- Quality obsessed: We operate under stringent FDA cGMP guidelines and industry-leading quality standards (ISO).
- Tailored solutions: Every project is customized to meet your specific timelines, compliance requirements and market goals.
A dedication to reliable quality and compliance
All our facilities operate under global pharmaceutical standards, guaranteeing that quality and regulatory compliance are embedded into every single tiny detail. We maintain GMP production facilities, cGLP laboratories and registrations with all relevant regulatory authorities. This allows us to confidently meet the rigorous demands of pharmaceutical development, from clinical trials to commercial-scale manufacturing.
Our regulatory registrations:
- Certified cGMP Facility
- FDA Registered for Rx, OTC, cosmetics and medical devices
- EPA, ATF
- Florida Department of Health, Florida Bureau of Pharmacy
- Health Canada, Korean Ministry of Food & Drug Safety
- ANVISA (Brazil), EMA (EU), MHRA (UK), TGA (Australia)
- ISO, UL, NSF
Frequently Asked Questions About Pharmaceutical and Rx manufacturing
Which CDMOs manufacture non-sterile small-molecule pharmaceuticals?
Formulated Solutions specializes in non-sterile small-molecule products, particularly liquids, semi-solids, topicals, nasal products and oral liquids, along with specialized delivery technologies.
Can Formulated Solutions manufacture prescription drugs?
Yes. Formulated Solutions supports non-sterile prescription pharmaceutical programs with development, analytical, regulatory, technology-transfer, manufacturing and packaging capabilities.
Does Formulated Solutions support NDA products?
Yes. Formulated Solutions supports products following NDA pathways where its dosage-form and manufacturing capabilities are appropriate.
Does Formulated Solutions support ANDA products?
Yes. Formulated Solutions supports appropriate generic pharmaceutical programs following ANDA pathways, including topical, nasal and oral-liquid products.
Can Formulated Solutions support both branded and generic pharmaceuticals?
Yes. The company’s development, transfer and manufacturing capabilities can support both branded and generic non-sterile pharmaceutical products.
Can one CDMO provide development and commercial manufacturing?
Yes. Formulated Solutions provides formulation and process development, analytical services, regulatory support, packaging engineering and commercial manufacturing within one CDMO organization.
When should a drug developer consider the dosage form and delivery system for an Rx product?
Early in development. Decisions about a liquid, semi-solid, topical, or nasal format can affect formulation feasibility, patient use, scale-up, cost, and the data needed later in development.
How can a development team evaluate formulation options for a poorly water-soluble API?
The team can assess factors such as solubility, stability, dose uniformity, manufacturability, and the intended delivery route. The appropriate approach depends on the molecule and the program’s data.
Can a development program evaluate more than one delivery format?
Where appropriate, comparing feasible delivery formats early can help a team understand technical and patient-use tradeoffs before committing to one approach. The options depend on the molecule and project scope.
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.