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Who This Is For

  • US D2C supplement brands looking for high-quality, cost-effective contract manufacturing in India
  • Amazon US and retail supplement brands transitioning from domestic US CMOs to an export-certified partner
  • Brands requiring 100% plant-based, vegan pectin gummies compliant with California Proposition 65 limits
  • US wellness companies seeking patented heat-stable probiotic gummies with guaranteed 24-month CFU counts
  • Startup supplement founders looking for low MOQ pilot batching (1,000 pouches) to test new formulations

What We Offer

US-FDA registered manufacturing facility operating under ISO 22000:2018 and central FSSAI licenses
Full alignment and compliance support for US 21 CFR Part 111 (Dietary Supplement cGMPs)
Rigorous California Proposition 65 heavy metal screening (ICP-MS testing for Lead, Cadmium, Arsenic, Mercury)
US Supplement Facts labeling compliance and permitted dietary ingredient verification
100% vegan, gelatin-free, non-GMO pectin gummy formulations engineered for US consumer preferences
Complete batch QA documentation: Certificate of Analysis (CoA), stability data, and allergen-free declarations

Review our verified site registration and international quality certifications on our Certifications & Quality Compliance page.

Technical Highlights

High-precision starchless mogul depositor technology providing ±1.5% active dosing accuracy

Patented microencapsulated probiotic thermal stabilization (Bacillus coagulans & Lactobacillus species)

Low water activity (aw < 0.65) engineering preventing microbial growth and bottle clumping

Clean-label natural color and flavor formulations matching US retail and Amazon quality benchmarks

Custom primary packaging: moisture-barrier zipper stand-up pouches and PET/HDPE amber bottles

Flexible low MOQ pilot production starting at 1,000 pouches to accelerate US market launches

Process & MOQs

Our R&D and QA teams work directly with US brand owners from initial Supplement Facts formulation design through pilot batching, Prop 65 testing, production, and seamless US Customs import clearance.

Turnkey Private Label Gummy Manufacturing for the US Market

Probiota Innovations Pvt. Ltd. provides specialized OEM/ODM contract manufacturing of pectin supplement gummies for US brand owners, Amazon sellers, and dietary supplement distributors. Manufactured in our US-FDA registered facility in Mysuru, India, our products combine world-class quality with highly competitive unit economics.

US 21 CFR Part 111 & California Prop 65 Compliance

Selling dietary supplements in the United States requires uncompromised compliance. Our manufacturing facility operates under Master Manufacturing Records (MMRs) and individual Batch Production Records (BPRs) compliant with US 21 CFR Part 111 standards. Furthermore, every production lot undergoes ICP-MS heavy metal testing to guarantee compliance with California Proposition 65 safe harbor levels (Lead < 0.5 mcg/day).

Certifications Held & Regulatory Pathways Supported

Certifications & Licenses Held: US-FDA Registered Facility, FSSAI Licensed Manufacturer, ISO 22000:2018 Certified, HACCP Certified, Halal Certified (100% Vegan Pectin Base).

Regulatory Pathways Supported: US 21 CFR Part 111 cGMP Compliance, California Proposition 65 Heavy Metal Testing, US-FDA Supplement Facts Labeling Guidelines, and US Customs Export Clearance Support.

Cost Savings & Flexible Low MOQs for US Founders

Partnering with Probiota offers US supplement brands a 40–60% cost advantage compared to domestic US contract manufacturers, without sacrificing quality. To help emerging US brands test new product concepts, we offer low minimum order quantities starting at just 1,000 stand-up zipper pouches (or 50,000 gummies in bulk).

Ready to scale your US gummy supplement brand? Contact our US export technical team today for a formulation review and competitive quote.

Ready to Get Started?

Share your product brief and our team will provide a detailed proposal within 48 hours.

Request a Quote