we make it happen In a gummy dosage form
1. Concept development
2. Evaluation / Prototyping/ Planning
2. Evaluation / Prototyping/ Planning
How do we develop your pharmaceutical gummy concept?
- We choose the APIs that are suitable for the business case (OTC, Rx, Ge & NCE)
- We set the baseline goals, requirements & assumptions- Defining the Target market, target pricing for manufacturer/end user, sales forecast, potential growth, and required regulation compliance
- We conduct a preliminary gummy design by determining the following: unit size, unit dose strength, package count, packaging technology, flavor, color, and other organoleptic attributes.
2. Evaluation / Prototyping/ Planning
2. Evaluation / Prototyping/ Planning
2. Evaluation / Prototyping/ Planning
How do we evaluate your gummy project's feasibility and mitigate the inherent development risks?
- Conduct a Literature review
- Conduct a Patent review
- Evaluate the API's Compatibility- Evaluate the compatibility of the API to the gummy production process, stability assessment, assess BE/BA risk drivers, and mitigation plan
- Prepare Gummy prototypes
- Establishing RA strategy
- Establish QTTP & a clear project plan
3. Gummy Development
2. Evaluation / Prototyping/ Planning
4. Bio-Equivalent/Availability Study
How do we develop pharmaceutical gummies?
- Our gummies are developed according to ICH/FDA regulations and QbD guidelines
- We apply unique taste masking technologies to achieve the best organoleptic attributes
- We design the primary packaging format from day one to ensure stability, maintain patient safety, promote sustainability, and ensure user convenience.
4. Bio-Equivalent/Availability Study
5. Dossier Preparation and Submission
4. Bio-Equivalent/Availability Study
- Conducting a bio-equivalent comparison study for Ge/OTC/Rx products to ensure that the generic gummy drug developed is similar to the reference drug on the market.
- Conducting Bio-availability and pharmacokinetic studies when developing NCE products
5. Dossier Preparation and Submission
5. Dossier Preparation and Submission
5. Dossier Preparation and Submission
Dossier preparation according to the relevant agency's requirements, and submission
6. Commercial production
5. Dossier Preparation and Submission
5. Dossier Preparation and Submission
How do we scale your drug gummy product for commercial production?
We tailor the production scale to your needs, resources, and business model:
1. Build the production and packaging gummy capabilities in your production facility
2. Establish production and packaging of gummy capabilities in our affiliate pharma companies tailor-made to your needs
3. Manufacture your product in our affiliate's top-notch pharma gummy production plant
7. Product Launch
7. Product Launch
7. Product Launch
Design packaging materials, API/excipients/packaging materials procurement, production & distribution
OUR EXPERTISE
One-stop shop for pharmaceutical gummies
We offer a comprehensive solution for establishing a pharmaceutical gummies business line. This includes product concept, development, regulatory affairs, submission, commercial-scale production, packaging, and distribution
Pharmaceutical Gummy Formulation
Our gummy formulations incorporate pharma-grade APIs and cutting-edge coating technologies to ensure optimal organoleptic properties, pharmacokinetics, and product stability
Production Process Technology
We customize state-of-the-art pharma-grade production technology from top machinery manufacturers to produce premium-quality pharmaceutical gummies
Packaging Technology
We employ unique blister packaging technology for packing gummies in secured child-resistance blister pack
Development programs:
Acetaminophen
Taste-masked Acetaminophen 80/160/250 mg gummies - Pain relief and fever treatment for pediatrics, child-resistant blister pack
Diphenhydramine
Taste-masked Diphenhydramine 12.5 mg gummies - relieve red, irritated, itchy, watery eyes, sneezing, and runny nose caused by high fever, allergies, or the common cold for pediatrics, child-resistant blister pack
Ibuprofen
Taste-masked Ibuprofen 100 mg gummies- Pain and fever treatment
Tadalafil
Tadalafil 10 mg gummies- Discreet, premium chewable designed to elevate confidence and intimacy with the power of tadalafil.
Methylphenidate
Methylphenidate IR 2.5 mg gummies- treatment for Attention Deficit and Hyperactivity Disorder (ADHD) in a child-resistance blister pack for Children (6 years and over)
