Oral and Topical Drug Product Manufacturing

DESIGNED FOR FLEXIBILITY THROUGHOUT CLINICAL DEVELOPMENT

Successful clinical-stage programs demand the right balance of speed, agility, and quality. Our oral and topical drug product manufacturing services are designed to deliver that balance by supporting efficient clinical supply while adapting to the realities of evolving development programs.

We support a wide range of dosage forms with flexible process trains that enable dependable drug product for both early- and late-stage clinical supply. This adaptability allows us to conserve material, manage cost, and respond quickly as data, timelines, or supply needs evolve.

Quality-driven oral and topical drug product manufacturing, from start to finish

Our experienced teams are equipped to manage demanding program requirements, including potent and controlled substances, light-sensitive compounds, targeted release profiles, and organic solvent processing. Throughout production, quality control remains central to supporting confident clinical supply and regulatory readiness.

Our oral and topical drug product manufacturing services include:

Tablet Manufacturing

Conventional tablets, film-coated tablets, bi-layer tablets, mini-tablets, and orally disintegrating, sublingual, or chewable tablets.

Capsule Manufacturing

Powder filled capsules, API in capsule, multiparticulate-filled capsules, liquid-filled capsules, and over-encapsulation.

Multiparticulates and Powders

Mini-tablets, wet-mass extruded pellets, drug-layered/coated pellets, and powders/granules for reconstitution.

Solutions, Suspensions, and Semi-Solids

Oral solutions and suspensions, pediatric products, and topical gels, creams, and ointments.

Biologics

Oral delivery is an emerging route of administration for biologics effective against disorders of the gastrointestinal tract. A major challenge in this work is maintaining the active form of the biologic drug as it passes through the low pH environment of the stomach.

Our team is skilled in protecting orally delivered biologics using functional coatings and other stabilizing excipients. We determine key attributes, including pl, molecular weight, and quaternary structure, to select and apply compatible processes.