About Kongdy Health | 36 Years OEM Patch Manufacturer Since 1989

Your Trusted Partner in Transdermal Patch Manufacturing

From concept to commercial scale — Kongdy Health delivers world-class transdermal patch OEM solutions with precision, compliance, and speed.

1989FDA Certified Since
20Ksqm ISO 13485 Facility
36+Years R&D Experience
10KPieces MOQ Available

Our Story

As a leading private label transdermal patch manufacturer and custom hydrogel patch supplier, Kongdy Health has been FDA certified since 1989 with headquarters in Zhoukou, Henan. We are a global leader in transdermal patch OEM/ODM. With 36+ years of R&D expertise, we’ve grown into a global OEM powerhouse — serving pharmaceutical, nutraceutical, and cosmetic brands across 120+ countries. Our 20,000 sqm ISO 13485 compliant facility houses state-of-the-art production lines and a dedicated innovation center.

Kongdy Health factory headquarters in Zhoukou, Henan

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Our Mission

Empowering global health brands with innovative, safe, and scalable transdermal patch solutions that improve patient outcomes.

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Our Vision

To be the world’s most trusted transdermal patch OEM — setting the standard for quality, sustainability, and therapeutic innovation.

🌍 Global Footprint

Serving the world from strategic hubs

120+

Countries

6

Continents

4

Distribution Centers

20K

sqm Facility

⚙️ Transdermal Patch Manufacturing Capabilities

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20,000 sqm ISO 13485

ISO Class 7 cleanrooms, 12 automated production lines

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Advanced Lamination

Multi-layer patch construction with precision coating

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End-to-End OEM

From formulation to sterile packaging & logistics

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500M+ Annual Output

Scalable capacity for global demand

🧬 R&D Innovation

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200+ Scientists

PhDs, pharmacists & material engineers

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$8M Annual Investment

Continuous innovation in patch technologies

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30+ Patents

Proprietary drug delivery systems

✅ Quality Assurance

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1. Raw Material Testing

100% incoming inspection & supplier audits

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2. In-Process Control

Real-time monitoring & statistical process control

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3. Finished Product QC

Dissolution, uniformity, stability & sterility tests

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4. Batch Release

Full traceability & regulatory documentation

🏅 Certifications & Compliance

View our key certifications below. Download official PDFs for your compliance documentation.

ISO 13485 2016 Certificate - Kongdy Health Medical Device QMS

ISO 13485:2016

Medical devices QMS · Global standard

View Details ↗

FDA Registration Certificate - Kongdy Health Since 1989

FDA Registered

US FDA 21 CFR 820 · Since 1989

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CE Marking Certificate - Kongdy Health EU MDR

CE Marked (MDR)

EU MDR 2017/745 · European access

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GMP Certificate - Kongdy Health Good Manufacturing Practice

GMP Certified

Good Manufacturing Practice · cGMP compliant

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👥 Leadership Team

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Dr. Wei Zhang

CEO & Founder

Ph.D. in Pharmaceutical Sciences, PKU. 36+ years in transdermal drug delivery & pharmaceutical manufacturing. Published 20+ peer-reviewed papers on patch formulation.

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Dr. Mei Li

VP of R&D

Ph.D. in Biomaterials Engineering, Zhejiang University. 20+ years specializing in transdermal drug delivery systems. 15+ patents in multi-layer patch technologies.

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James Chen

COO

Operations & supply chain specialist

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Sarah Liu

VP of Quality

Regulatory affairs & compliance leader

💎 Corporate Values

Quality First

Zero compromise on product integrity

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Customer Centric

Your success is our mission

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Innovation

Pushing boundaries of patch technology

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Integrity

Transparency in every partnership

🌱 Sustainability

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Solar Powered

40% of energy from on-site solar panels

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Zero Waste

98% waste recycling rate in production

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Water Stewardship

Closed-loop water treatment system

💬 Customer Success

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“Kongdy Health delivered our complex multi-layer patch on time with exceptional quality. True partners in innovation.”

— Dr. A. Patel, PharmaCorp 🇺🇸

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“Their R&D team helped us optimize our formulation for better adhesion and release profile. Outstanding expertise.”

— M. Torres, BioHealth Europe 🇪🇸

⭐⭐⭐⭐⭐

“The most reliable OEM partner we’ve worked with. Regulatory documentation was flawless for FDA submission.”

— K. Yamamoto, MediPatch Japan 🇯🇵

📅 Our Journey

1989
Founded in Zhoukou, Henan with a single production line
2013
First international client & ISO 13485 certification
2017
Expanded to 20,000 sqm ISO 13485 certified facility, FDA registration
2021
500M annual patch capacity, CE marking achieved
2024
Opened EU distribution center, 30+ patents filed
2026
Launching next-gen smart patch technology

🏆 Awards & Recognition

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Best OEM Partner 2023

Global Pharma Awards

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Innovation Leader 2022

Transdermal Tech Summit

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Top 50 Chinese Pharma

Industry Excellence List

🏭 Factory Gallery

Kongdy ISO Class 7 cleanroom for transdermal patch production
Kongdy R&D laboratory for patch formulation and stability testing
Kongdy sterile packaging line - high speed automated packaging
Kongdy quality control laboratory dissolution and stability testing

📊 OEM/ODM Service Specifications

Feature Specification
MOQ 10,000 pieces per SKU (trial orders from 5,000)
Lead Time 6–8 weeks from formulation approval; fast-track available
Certifications FDA Registered, ISO 13485:2016, GMP, CE Marked (MDR)
Patch Types Transdermal Drug Delivery, Cooling, Pain Relief, Hydrogel, Nicotine, Cosmetic, Weight Loss, Sleep, Vitamin, Mosquito Repellent, Eye Steam Mask
Packaging Options Private label, custom pouch, multi-language packaging, retail-ready boxes
Regulatory Support DMF filings, FDA submissions, CE technical files, 120+ countries registration

❓ Frequently Asked Questions

What types of patches do you manufacture?

We produce transdermal drug delivery patches, nicotine patches, pain relief patches, cosmetic patches, and nutraceutical patches in various sizes and release profiles.

What is your minimum order quantity (MOQ)?

Our MOQ starts at 10,000 patches per SKU, with flexible scaling options for pilot batches and commercial production.

Do you handle regulatory submissions?

Yes, our regulatory team supports DMF filings, FDA submissions, CE technical files, and global registration documentation.

What is your typical lead time?

Standard lead time is 6-8 weeks from formulation approval. Rush orders can be accommodated for qualified partners.

Can you develop custom formulations?

Absolutely. Our R&D team specializes in custom drug-in-adhesive, matrix, and reservoir patch formulations tailored to your API.

Ready to Partner with Kongdy Health?

Request free samples and a preliminary quote. Our team responds within 12 hours. All inquiries protected by NDA.

Send Us Your Inquiry

Tell us your requirements — we usually respond with a preliminary quotation and sampling plan within 12 hours.

🔒 Your information is confidential. NDA available upon request.

🔒 100% Secure & Confidential. We sign NDA within 24 hours for qualified buyers.