OTC
Proven Expertise in Safe, Accessible, and Compliant OTC Formulations
At MedPharm, we bring deep expertise to the development and manufacturing of Over-the-Counter (OTC) drug products. Whether you’re creating a new topical formulation, improving an existing one, or preparing for regulatory submission, we provide scientifically driven solutions that ensure your product is safe, effective, and market-ready.
Our team specializes in topical and transdermal OTC products, including creams, gels, sprays, and solutions designed for a wide range of therapeutic categories—such as dermatology, pain relief, wound care, and antifungal applications.
Why MedPharm for OTC Development?
Extensive OTC Drug Expertise
Deep experience with Monograph-compliant and NDA-pathway OTC products across key therapeutic classes.
Formulation-to-Filing Support
We provide end-to-end services from pre-formulation and formulation development to analytical testing, stability studies, and regulatory dossier support.
Patient-Centric Formulations
Our semi-solid and liquid formulations are optimized for comfort, absorption, and shelf-life—enhancing both user experience and therapeutic performance.
Rapid Development Timelines
Accelerated development using validated analytical methods, proprietary in vitro testing platforms, and efficient scale-up capabilities.
Regulatory Compliance and Quality Assurance
All development and manufacturing activities are conducted under cGMP and ICH-compliant conditions, supporting 21 CFR Part 330 and global OTC standards.
Typical OTC Product Types We Support:
- Topical pain relievers and anti-inflammatories
- Antifungal creams and nail lacquers
- Skin barrier and moisturizing formulations
- Antiseptic and wound care products
- Nasal sprays and ophthalmic solutions
