FOR PROFESSIONAL AESTHETIC MEDICAL USE ONLY  Β·  CE-Marked  Β·  Exporting to 40+ Countries
✦ Manufacturing Partnership

OEM / ODM Services

Launch your own branded lip filler β€” built on the proven CEHISHU B12 + HA platform

Private Label Manufacturing

Your Brand, Our Science

Leverage our formulation expertise, GMP-certified facility, and regulatory experience to bring a premium lip filler to market under your own brand name. From formula customization to regulatory dossiers β€” we handle the science, you own the brand.

01

Formulation Customization

Start from our proven B12 + fractionated-HA platform and tailor the HA concentration, B12 percentage, or add proprietary actives to differentiate your brand. Our R&D lab develops the formula to your specification.

02

Private-Label Packaging

Custom syringe design, retail carton artwork, IFU inserts, and multi-language labeling β€” all compliant with your target market's medical device packaging requirements.

03

Regulatory Dossier Support

We prepare the technical documentation package for CE marking, FDA 510(k) submission, and regional registrations. You receive a ready-to-file dossier under your brand's name.

04

Clinical Evidence Package

Access our clinical study data and before/after case library to support your marketing and regulatory submissions. Custom clinical studies can be arranged for premium tiers.

05

Cold-Chain Logistics

Validated cold-chain export packaging with temperature loggers, full documentation, and global courier network. We ship to 40+ countries with chain-of-custody verification.

06

Dedicated Account Team

Every OEM partner gets a dedicated project manager, R&D liaison, and regulatory specialist. Direct communication, transparent timelines, and milestone-based progress updates.

How It Works

The OEM Partnership Process

From first inquiry to your branded product shipping β€” a clear, milestone-driven process.

1

Consultation

Share your brand vision, target market, and volume forecast. We assess feasibility and propose a formulation direction.

2

Sample Development

Our R&D lab develops pilot batches. You review, test, and approve the formulation, viscosity, and presentation.

3

Regulatory & Packaging

We prepare the technical dossier and finalize your branded packaging, labeling, and IFU in target-market languages.

4

Production & Export

GMP production, quality control, cold-chain packaging, and global shipping β€” with full documentation for your import.

Partnership Models

OEM Tier Comparison

Three tiers to match your business scale and ambition.

Feature Starter OEM Brand Builder Exclusive Partner
Minimum Order Quantity 1,000 syringes 5,000 syringes 20,000+ syringes
Formulation Standard CEHISHU formula Adjusted HA / B12 levels Custom proprietary blend
Branding Your logo on standard packaging Custom packaging design Fully bespoke brand identity
Regulatory Dossier Standard CE documentation CE + target-market registration support Full dossier + clinical data package
Territory Non-exclusive Preferred partner status Exclusive territory rights
Lead Time 25–30 business days 30–40 business days Project-based timeline
Support Email support Dedicated project manager Full account team + R&D liaison
Pricing On request Volume-based, on request Custom quotation
Request OEM Quotation
Our Facility

Manufacturing Capabilities

GMP-certified production built for medical-grade injectables.

🏭

ISO 13485 Facility

Cleanroom manufacturing (Class 7/8), validated sterilization, and full traceability for every production batch.

πŸ”¬

In-House R&D Lab

Formulation scientists dedicated to HA and vitamin-delivery systems. Pilot batches, rheology testing, and stability studies under one roof.

πŸ“Š

Quality Control

Every batch tested for viscosity, particle size, endotoxin, sterility, and B12 content. Certificate of Analysis with every shipment.

❄️

Cold-Chain Export

Validated 2–8Β°C shipping packaging with temperature loggers. Global courier network covering 40+ countries.

πŸ“‹

Regulatory Affairs

In-house regulatory team preparing CE dossiers, FDA submissions, and regional registrations β€” technical files maintained and updated.

🌍

Global Export Experience

Active in 40+ markets across Europe, Americas, MENA, and APAC. We know the import requirements and documentation for each region.

Compliance & Certifications

Our Quality Credentials

βœ…

CE Mark

Medical Device Class III

🏭

ISO 13485

Medical Device QMS

πŸ”¬

GMP Certified

Good Manufacturing Practice

πŸ“‹

FDA Registered

Facility Registration

πŸ‡ͺπŸ‡Ί

EU Authorized Rep

European Compliance

🚒

Export Licensed

Customs Approved

🌑️

Cold-Chain Validated

2-8Β°C Shipping

πŸ“š

Full Documentation

CoA Β· CoO Β· DoC

Build Your Brand With CEHISHU

Tell us about your brand vision, target market, and volume forecast β€” we'll respond within 24 hours with a tailored OEM proposal.

Request OEM Consultation
↑