OEM Manufacturing & Commercial Distribution Launch Your Own OTC Product with Confidence

At Oripeutic, we specialize in OEM manufacturing and exclusive commercial distribution of FDA-cleared over-the-counter (OTC) diagnostic products, including pregnancy tests and point-of-care health solutions. Whether you're an emerging health brand or an established company expanding into retail, we help you bring your product to market—fast, compliant, and ready for shelf.

 

 

 

Why Partner with Oripeutic?

• ✔ FDA OTC Compliance
  510(k)-cleared products, CLIA-waived options, and labeling aligned with U.S. retail requirements.

• ✔ Private Label / White Label Solutions
  End-to-end support—from packaging design to GS1 barcoding and IFU creation.

• ✔ National Retail Distribution
  Access to U.S. pharmacy chains, mass merchandisers, and health product distributors.

• ✔ Fast Turnaround
  Streamlined onboarding, production, and retail deployment.

• ✔ Regulatory Expertise
  Built-in quality, risk, and compliance support to navigate FDA, FTC, and labeling standards.

 

 

Services We Offer

OEM / White Label Manufacturing

• Custom-branded OTC pregnancy and diagnostic test kits

• Branding, packaging, and labeling support

• CLIA-waived and consumer-friendly formats

• Serialization, UPC & GS1 barcoding

• Shelf-ready packaging and fulfillment

Commercial Distribution

• Retail placement and supply chain coordination

• MAP/MSRP compliance support

• Regional warehousing and drop-shipping

• Retailer onboarding kits and B2B sales enablement

• Returns and product lifecycle support

Ideal for:

• ✔ Direct-to-consumer health startups

• ✔ Global diagnostic brands entering the U.S. market

• ✔ Pharmacies and health chains seeking private label products

• ✔ Distributors looking for white-label expansion

 

 

How It Works

1. Discovery & Fit
Tell us about your goals—whether it's a new brand launch, retail expansion, or contract distribution.

 

2. Design & Compliance
We finalize packaging, labeling, and regulatory documents with you.

 

3. Manufacturing
Production begins with our FDA-registered, ISO 13485–certified partners.

 

4. Distribution
We place your product across pharmacies, e-commerce, or bulk B2B buyers.