Innovating Nutritional and OTC Drug Gummies

Gummies are an ideal delivery system for improving compliance among patients who don’t like to take medication in pill or liquid forms. A complex and challenging manufacturing process, PLD uses its extensive expertise in OTC and Rx drug development, scale up, and manufacturing to ensure the highest quality, consistent gummy product with the appropriate texture and dosing accuracy.

PILOT CENTER
Our Miami facility is a state-of-the pilot center offering a full R&D and analytical lab for pilot manufacturing and scale up.

• Experience in clinical trials and BE studies
• A library of formulations
• Flavor masking expertise
• Enhanced R&D lab for product development
• World-class benchtop lab to facilitate rapid gummy development
• Experience working with actives in a variety of solid dosage forms enables control of actives within a gummy matrix
• Seasoned technical operation specialist working exclusively on bench-to scale-up execution

MANUFACTURING
Our gummy manufacturing plant is a GDUFA-paying facility that’s built to be FDA 21 CFR part 210 and 211 CFR compliant and 111 for supplements. We have the capability and capacity for custom development from new formulas to reverse engineering existing formulations.

• New, modern, custom equipment in dedicated production rooms with separate HVAC systems
• Customized production equipment including air control, temperature control, humidity control, true negative/positive air pressure and air locks
• Four gummy lines with capacity to produce 1B+ gummies annually
• Starchless process
• Custom blend uniformity
• Custom dosage accuracy
• Purity
• No cross contamination
• Gummies are quickly released from the mold to be dried in dedicated suites

PACKAGING
Our gummy packaging capacity exceeds 50M annual units with space to expand to 100M annually.
We utilize:

• Precision channels counters — not weigh fillers
• Full body sleeve or pressure sensitive labeling
• Metal detection
• Checkweigher to ensure correct bottle count
• HEPA filtered/temperature control environment
• 6ct to 12ct bundled inner packs
• Palletization/fully enclosed pallet wraps
• Individual batch folder reconciliation per run

FORMULATION
A variety of formulas are available with extensive flavor offerings and mold types to suit your production.
Custom shapes can be accommodated with a lead time of 8 to 12 weeks. Our portfolio includes:

Multivitamins
Prenatal
Men’s/women’s/children’s
Hair, skin and nails

Specialized nutrition
Melatonin
Apple cider vinegar 
Sleep complex
Zinc
Elderberry immune complex
Ashwagandha
Fiber

Sugar-free
Vitamin D
Vitamin C
Melatonin
Children’s melatonin