Watch our short video explaining the pharmaceutical gummy drug-product concept : https://youtu.be/Dm1emU9J9k8
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Pharmmies is a specialized pharmaceutical drug-product development company focused on API-containing gummy dosage forms. We lead programs from feasibility, formulation and taste masking through prototype development, pilot scale-up, analytical and regulatory planning, GMP technology transfer, commercial manufacturing and supply coordination. Activities are performed directly or through qualified partners according to the needs of each program. Pharmmies does not develop standard confectionery or dietary supplement gummies
Pharmaceutical gummies are chewable oral dosage forms containing an active pharmaceutical ingredient. They are designed to deliver a defined drug dose in a palatable format and may address swallowing or acceptability challenges associated with tablets, capsules or liquid medicines. Like any drug product, they require appropriate formulation, analytical controls, stability, packaging and regulatory development
Yes. Pharmmies offers a structured feasibility and preliminary development-planning assessment for pharmaceutical gummy products. This is designed for entrepreneurs, pharma companies, and partners who want to understand whether a proposed medicated gummy concept can realistically become a regulated drug product. The assessment typically reviews the product concept, target product profile, formulation and taste-masking challenges, analytical and dissolution considerations, regulatory pathway, bioequivalence risks, stability strategy, development timeline, estimated budget, key decision gates, and commercial positioning. The goal is to give you a practical development roadmap — not just a technical opinion. You should come out of the process with a clearer understanding of what needs to be developed, what the main risks are, what questions may need to be aligned with FDA or other regulators, how much the program may cost, how long it may take, and what the next development phase should include.
No. Feasibility depends on dose load, taste, solubility, particle size, heat and pH sensitivity, interactions with the gummy matrix, dissolution requirements, stability, unit size and the intended regulatory pathway. Each API should be assessed before substantial development investment.
The main challenges typically include dose loading and content uniformity, taste masking, API release and dissolution, process conditions, moisture and texture control, microbial risk, packaging, shelf-life and scale-up. The relative importance of each risk depends on the API and target product profile
Programs normally begin with a feasibility and product-definition phase. This phase reviews the API, dose, target population, reference products, target market, preliminary regulatory assumptions, technical risks and an initial development route. Prototype work is then proposed based on the findings.
Yes. Pharmmies can take a program beyond development by selecting and coordinating qualified GMP manufacturers, analytical laboratories, packaging suppliers and supply partners. Pharmmies remains the accountable program lead; manufacturing, testing and distribution activities are performed by appropriately qualified and authorized partners
Yes. Pharmmies can support CDMO selection, transfer-package preparation, process and material definition, analytical development and validation, stability planning, engineering and GMP batch readiness, packaging strategy and cross-functional execution. GMP manufacturing and testing are performed by appropriately qualified partners under the coordinated program.
Yes, subject to program-specific regulatory assessment. The required pathway depends on the active ingredient, intended claims, reference product, dosage-form differences and target market. Regulatory assumptions should be validated early with appropriately qualified regulatory experts
Pharmmies has development-stage experience with acetaminophen/paracetamol, ibuprofen and diphenhydramine gummy concepts, including formulation, taste-masking and pilot-scale activities. These programs should not be interpreted as approved or commercially available products.
Please provide the API, target dose, target patient population, intended market, reference product if applicable, current development stage, expected annual volume and the specific support required. Confidential information can be discussed after an appropriate confidentiality agreement is in place
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