Semi-Solid Dosage Form Manufacturing & Development

UPM Pharmaceuticals is an award-winning, US-based contract development and manufacturing organization (CDMO) specializing in semi-solid dosage form manufacturing — from early-stage formulation development through full-scale commercial production. With decades of experience and a 475,000-square-foot cGMP facility in Bristol, Tennessee, UPM offers pharmaceutical sponsors unmatched expertise in semi-solid drug product development, manufacturing, and handling. Our state-of-the-art facilities are designed to meet the stringent requirements of the pharmaceutical industry, making us a leader in this specialized field. By focusing on advanced technologies and strict regulatory compliance, UPM serves as a trusted semi-solid CDMO partner for pharmaceutical companies of all sizes — from emerging biotech to established brand-name and generic drug manufacturers. With our specialized capabilities in semi-solid pharmaceutical drug product manufacturing, we are ready to elevate your product's market readiness from concept to commercialization.

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cGMP Manufacturing & Packaging of Semi-Solid Drug Products

Semi-solid drug product manufacturing demands precision at every stage — from API and excipient distribution through final container closure. For semi-solid pharmaceutical products, ensuring the appropriate distribution of APIs and excipients is essential for creating a product that is both efficacious and marketable, making batch-to-batch consistency at the product and process levels the key factor for success with semi-solids.

UPM's cGMP-compliant manufacturing and packaging operations cover the complete production lifecycle for semi-solid drug products, including:

Semi-Solid Dosage Form Manufacturing Capacity

UPM has extensive experience producing commercial-scale semi-solid pharmaceutical products, with cGMP production capacity of 1,300,000 kilogram units annually of creams and ointments on a single shift — positioning UPM as one of the largest dedicated semi-solid CDMOs in the United States. Our expertise spans all phases of semi-solid drug product manufacturing, including the formulation development of semi-solid dosage forms, commercial-scale manufacturing, and pharmaceutical packaging.

Semi-Solid Dosage Forms We Manufacture

UPM's semi-solid manufacturing capabilities span the full range of topical and transdermal pharmaceutical dosage form types. We manufacture:

  • Creams — Oil-in-water or water-in-oil emulsions for topical drug delivery to the skin and mucous membranes

  • Ointments — Oleaginous, semi-occlusive preparations designed for sustained API release, skin protection, and treatment of dermatological conditions

  • Gels — Aqueous or hydro-alcoholic formulations offering clear, smooth textures suited for topical and transdermal drug delivery

  • Lotions — Lower-viscosity emulsions formulated for easy application over large body surface areas

Whether your program involves a Rx topical or a hormone-based gel, UPM has the formulation expertise and cGMP infrastructure to bring it to market reliably and compliantly.

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Semi-Solid Formulation Development

A successful semi-solid drug product starts with getting the formulation right. UPM's formulation scientists and R&D team work collaboratively with clients during the development phase to:

  • Define the optimal base type (oleaginous, water-washable, emulsion, or water-soluble) for your API and therapeutic indication

  • Conduct pre-formulation studies and API-excipient compatibility assessments

  • Develop and optimize emulsion stability, rheology, viscosity, and pH profiles

  • Design and execute stability studies in support of IND, NDA, and ANDA submissions

  • Perform analytical method development and validation specific to semi-solid dosage forms

  • Support technology transfer and scale-up from lab-scale or clinical batches to full commercial manufacturing

UPM's formulation development team brings deep category expertise across dermatology, pain management, and hormone therapy drug segments — enabling faster development timelines and a smoother path through FDA regulatory review.

Why Choose UPM as Your Semi-Solid CDMO?

Selecting UPM Pharmaceuticals for your semi-solid dosage form manufacturing ensures collaboration with a leader in US-based pharmaceutical manufacturing. We provide a comprehensive suite of CDMO services — from formulation development to validated commercial production — facilitating a seamless process tailored to your needs. Our commitment to quality is reflected in every product batch, maintaining the highest standards of cGMP compliance, regulatory integrity, and on-time delivery. We are deeply adept at addressing the unique challenges of semi-solid formulations, drawing on decades of hands-on expertise to offer effective solutions.

What sets UPM apart as a semi-solid pharmaceutical CDMO:

Our team is dedicated to guiding you seamlessly from concept to market, ensuring that each phase of the process meets the highest standards of quality and efficiency. Experience the advantages of partnering with a leader in semi-solid dosage form manufacturing by starting your project with us today.

Frequently Asked Questions About Semi-Solid Pharmaceutical Manufacturing

What is a semi-solid dosage form?

A semi-solid dosage form is a pharmaceutical preparation that is neither fully solid nor fully liquid. Common semi-solid drug products include creams, ointments, gels, pastes, and lotions. These formulations are primarily applied topically to the skin or mucosal membranes and are designed to deliver active pharmaceutical ingredients (APIs) in a controlled and localized manner. Semi-solid dosage forms are widely used across therapeutic areas including dermatology, pain management, and hormone therapy.

What types of semi-solid drug products does UPM Pharmaceuticals manufacture?

UPM manufactures a full range of semi-solid drug products, including creams, ointments, gels, lotions, and pastes. Our cGMP facility is equipped to handle both prescription topical formulations — including hormone-based products and DEA-licensed controlled substance topical compounds — across a variety of therapeutic categories.

What is UPM's production capacity for semi-solid manufacturing?

UPM maintains cGMP production capacity of 1,300,000 kilogram units annually of semi-solid drug products (creams and ointments) on a single shift. This large-scale capacity makes UPM one of the highest-volume semi-solid CDMOs in the United States, able to support both growing commercial programs and long-term supply commitments.

Does UPM offer semi-solid formulation development, or only commercial manufacturing?

UPM is a full-service CDMO — meaning we support semi-solid drug products across the entire product lifecycle, from early-stage formulation development through post-approval commercial supply. Services include pre-formulation studies, formulation optimization, analytical method development, stability testing, clinical batch manufacturing, technology transfer, scale-up, and ongoing commercial production.

What regulatory standards govern UPM's semi-solid drug manufacturing operations?

UPM's semi-solid manufacturing operations comply fully with FDA current Good Manufacturing Practice (cGMP) regulations. Our Bristol, Tennessee facility has an established track record of successful FDA inspections. We also hold DEA licensure for controlled substance manufacturing and provide full documentation support for NDA, ANDA, and IND submissions.

What packaging formats are available for semi-solid drug products at UPM?

UPM offers comprehensive pharmaceutical packaging services integrated directly with semi-solid manufacturing, including tube filling (aluminum and plastic), jar filling, pump dispensers, and full secondary packaging. Integrating packaging within the same facility ensures continuity of quality control, reduces the risk of contamination or handling errors, and eliminates the lead time associated with third-party packaging handoffs.

How do I get started with UPM as my semi-solid CDMO partner?

To begin a project discussion, complete the Request a Quote form below or contact UPM directly. Our business development team will connect with you to understand your product profile, therapeutic category, development stage, and manufacturing volume requirements — and outline a tailored path forward for your semi-solid drug product.

Ready to Move Forward with Your Semi-Solid Drug Product?

Whether you are in early formulation development or ready to transition an approved product to commercial-scale cGMP manufacturing, UPM Pharmaceuticals has the capacity, expertise, and regulatory track record to support your program from start to sustained supply.

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