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, and calculate the odds of succeeding in the B.E study
- Prepare Gummy prototypes
- Establish QTTP & a clear project plan
- Establishing RA strategy
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. This study aims to achieve a 90% confidence interval of the ratio of a log-transformed exposure measure (AUC and/or Cmax) that falls entirely within the range of 80-125%
- 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
Our company offers a comprehensive solution for establishing 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
in the PIPELINe:
ACETAMMIES™
12*Taste-masked Acetaminophen 80 mg gummies - Pain relief and fever treatment for pediatrics, child-resistant blister pack
IBUMMIES™
12* Taste-masked Ibuprofen 100 mg gummies- Pain and fever treatment
GUMMICILLIN™
12* Amoxicillin 250 mg gummies- a penicillin antibiotic treatment against a variety of bacterial infections
BENDAMMIES™
6*Mebendazole 100mg gummies- treatment for gut infections (worms) in a child-resistance blister pack for Children (6 years and over)
RITAMMIES™
28*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)
