Gummi World Makes History: First U.S. Gummy Manufacturer to Earn Over-the-Counter Drug Certification

Breakthrough OTC 455-4 Certification Positions Gummi World as the First Pharmaceutical-Grade Gummy Partner in the U.S.

CHANDLER, AZ / ACCESS Newswire / June 12, 2025 / Gummi World, a wholly owned subsidiary of Intiva Group and an industry leader in custom supplement manufacturing, has achieved a historic milestone, becoming the first gummy manufacturer in the United States to receive OTC 455-4 certification. This officially designates the company as a compliant manufacturer of over-the-counter (OTC) drug products in gummy form, bridging the gap between consumer-friendly formats and pharmaceutical-grade production standards. Gummi World now has the authority to formulate, produce, and package FDA-compliant OTC medications in gummy form.

"With this OTC certification, Gummi World is changing what's possible for gummy manufacturing," said Alexander C. Candelario, Chairman and CEO of Intiva Group, Gummi World's parent company. "Being the first U.S. gummy manufacturer to receive OTC certification reaffirms our dedication to innovation, quality, and regulatory excellence. Our partners now have access to a manufacturing platform that combines clinical-grade precision with unmatched speed to market."

A First in the Gummy Industry

OTC 455-4 is one of the toughest certifications in the U.S., usually limited to pharmaceutical companies making pills or liquids. Gummi World's OTC certification breaks that mold, proving that gummies can now be a credible, FDA-compliant way to deliver OTC medications.

This distinction authorizes Gummi World to manufacture and package pharmacy-grade OTC medications in gummy form, including:

• Pain relievers (acetaminophen, ibuprofen)

• Cold and flu symptom relievers

• Sleep aids

• Antihistamines

For retailers and product developers, this opens new opportunities: delivering effective medications in formats consumers prefer without compromising compliance or efficacy.

One Roof. Total Compliance.

This achievement is backed by Gummi World's FDA-registered, vertically integrated facility in Chandler, Arizona. With formulation, manufacturing, packaging, and quality control under one roof, every step is tightly controlled, providing clients with full traceability, rapid turnaround, and airtight compliance from concept to shelf.

Gummi World's infrastructure now supports:

• OTC-compliant production with validated tracking and documentation

• In-house stability, microbial, and heavy metal testing

• Scalable operations for pilot runs or national distribution

• Capsule manufacturing for powders, semi-solids, and select liquids

Why This Matters to Brands & Retailers

For Gummi World's clients, from global wellness brands to startups, this certification means:

• Access to true OTC products in gummy form, made under FDA oversight

• A trusted, turnkey partner ready to handle compliance from day one

• Speed-to-shelf solutions without compromising safety, flavor, or efficacy

• Pharmaceutical credibility that meets the standards of major retailers

"By becoming OTC certified, we're helping our clients expand into new product categories that were previously out of reach for gummies," said Candelario. "We're proud to help them be first to market, not just compliant."

Setting a New Standard for the Industry

While many manufacturers are still catching up, Gummi World is setting the pace by bringing pharma-level standards to the consumer health space. This OTC certification marks the first of several expansions planned for 2025 as the company evolves into a full-scale pharmaceutical-grade contract partner, positioned to lead the market in next-generation gummy drug delivery. From national retailers to global nutraceutical brands and pharmaceutical innovators, Gummi World is ready to deliver. Learn more or request a quote at www.gummiworld.com.

SOURCE: Gummi World