start with why

• Choosing APIs that are suitable to the business case (OTC, Rx, Ge & NCE) 
• Setting baseline goals, requirements &  assumptions- Define Target market, target pricing for manufacturer/end user, sales forecast, potential growth, and required regulation compliance 
•  Preliminary design- Unit size, unit dose strength, package count, packaging technology, flavor, color, organoleptic attributes

• Literature review
• Patent review
• API Compatibility evaluation- Evaluate the compatibility of the API to the gummy production process, stability assessment, and calculate the odds of succeeding in the B.E study
• Manufacturing and testing preliminary gummy prototypes
• Establish QTTP & a clear project plan
• Establishing RA strategy

• Develop the medicated gummies according to ICH/FDA regulations and QbD guidelines
• Applying taste masking technologies to achieve the best organoleptic attributes
• Design the product packaging to ensure stability, maintain patient safety, promote sustainability, and ensure user convenience.

• 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 

Prepare the dossier according to the relevant agency's requirements,  and submission

Commercial scale production tailored to your needs, resources and business model:

1. Tailor-make 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  

Design packaging materials, API/excipients/packaging materials procurement, production & distribution

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.  

We formulate pharmaceutical gummies with unique pharma-grade ingredients and APIs to achieve the best organoleptic, pharmacokinetic, and quality attributes    

We customize state-of-the-art pharma-grade production technology from top machinery manufacturers to produce premium-quality pharmaceutical gummies

We employ unique blister packaging technology for packing gummies in secured child-resistance blister pack   

24*Taste-masked Acetaminophen 120 mg gummies - Pain relief and fever treatment for pediatrics, child-resistant blister pack

12* Taste-masked Ibuprofen 100 mg gummies- Pain and fever treatment  

12* Amoxicillin 250 mg gummies-  a penicillin antibiotic treatment against a variety of bacterial infections 

6*Mebendazole 100mg gummies- treatment for gut infections (worms)  in a child-resistance blister pack for  Children (6 years and over) 

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)