Turnkey CDMO Partner
From Concept to
Commercialization
End-to-end drug-device combination solutions for insulin pen
manufacturers - industrial design, patent strategy, mold
development, aseptic filling, automated assembly, and global
regulatory support.
End-to-End Steps
Days to First Mold
Filling Accuracy
PPM Assembly Speed
End-to-End Capabilities
Our 8-Step Turnkey Process
01 Industrial & Structural Design
User-centric ergonomic design focusing on low injection force, clear dose display, and comfortable grip. Covers both disposable and reusable pen platforms.
| ISO 11608-1 | 3D Prototyping | ID/MD Design |
02 Patent Strategy & FTO Analysis
Comprehensive Freedom-to-Operate (FTO) analysis across US, EU, and key Asian markets. We design around existing patents to ensure clean market entry.
| USPTO Search | EPO Analysis | Design-Around |
S136 steel molds guaranteed for ≥1,000,000 shots. 32–64 cavity tooling with Husky/Yudo hot runner systems. All production in ISO Class 8 cleanrooms.
| S136 Steel | 64-Cavity | ISO Class 8 |
04 Component Injection Molding
Full-scale production of all pen components - pen body, dose dial, cartridge holder, needle cap - with 100% dimensional inspection and traceability.
| Medical Grade | 100% Inspection | GMP Cleanroom |
05 Aseptic Filling (Insulin & GLP-1)
Isolator-based aseptic filling for insulin, , and other GLP-1 drugs. Ceramic pump systems achieving ±0.5% accuracy at up to 600 CPM.
| ±0.5% Accuracy | 600 CPM | SAL 10⁻⁶ |
06 Automated Pen Assembly Line
Cam-driven continuous motion assembly achieving 60–300 PPM. Integrated Keyence/Cognex vision inspection, torque testing, and 21 CFR Part 11 SCADA.
| 300 PPM | Vision Inspection | 21 CFR Part 11 |
07 Drug-Device Final Assembly
Precision cartridge integration, snap-fit locking, GS1 DataMatrix serialization, and cold-chain ready secondary packaging - all in GMP Class C/D.
| Track & Trace | GS1 DataMatrix | Cold Chain |
08 GMP / FDA Compliance & Regulatory
Complete validation documentation (DQ/IQ/OQ/PQ), GAMP5 CSV support, and assistance with FDA 510(k), NDA, and CE MDR submission dossiers.
| ISO 13485 | EU MDR | FDA 510(k) |
Aseptic Filling
Insulin & GLP-1
Drug Filling
Our isolator-based aseptic filling lines handle insulin, (Ozempic/Wegovy generics), and other GLP-1 biologics with the highest sterility assurance levels required for injectable drug products.
±0.5%
Filling Accuracy
600 CPM
Output Speed
SAL 10⁻⁶
Sterility Level
ISO Class 5
Environment
Mold Development
High-Precision
Injection Molds
From concept to T1 sample in as little as 45 days. Our S136 steel molds are engineered for medical-grade precision and guaranteed for over one million shots, ensuring long-term production reliability.
S136 steel with ≥1,000,000 shot guarantee
32 to 64-cavity with Husky/Yudo hot runners
ISO Class 8 cleanroom production
Full mold flow analysis (Moldflow) before cutting
Lifetime mold warranty included
Competitive Advantages
Why Choose DROFEN?
8 Steps, 1 Partner
One-Stop Integration
Seamless execution from industrial design to final assembly, eliminating multi-vendor coordination risk.
30–50% Savings
Cost Efficiency
Leveraging China's precision manufacturing ecosystem to deliver 30–50% cost savings vs. European competitors.
45-Day Molds
Speed to Market
Rapid prototyping and mold development in as little as 45 days to accelerate your product launch timeline.
FDA + CE + ISO
Compliance Ready
Full adherence to FDA 21 CFR Part 4/11 and ISO 11608 with complete validation documentation packages.
Zero IP Risk
Innovation & FTO
Expert patent analysis and design-around strategies to ensure Freedom-to-Operate in all target markets.
24/7 Support
Global Support
On-site installation, operator training, and 24/7 remote technical support to ensure continuous operation.
Regulatory Excellence
GMP / FDA
Compliance Ready
We don't just build equipment - we deliver complete compliance packages. Our validation documentation, facility design, and regulatory support services are designed to help your product pass audits on the first attempt.
FDA
COMPLIANT
CE MDR
COMPLIANT
ISO 13485
COMPLIANT
Standards We Support
FDA 21 CFR Part 4 (Combination Products)
FDA 21 CFR Part 210/211
ISO 11608-1 (Needle-based Injection Systems)
ISO 13485:2016
GAMP 5 (Computer System Validation)
EU MDR 2017/745
21 CFR Part 11 (Electronic Records)
ICH Q10 (Pharmaceutical Quality System)
Proven Results
Success Stories
Europe · Poland
Top 5 Generic Pharma
Challenge
Needed a fully automated EU GMP-compliant assembly line within 8 months to beat competitors to market.
Solution
Delivered a 12,000 UPH line with integrated vision inspection and auto-packaging, validated to PQ.
Result
Launched 1 month early; reduced labor costs by 80%.
"The speed and precision of Drofen's line exceeded our expectations. A true partner."
Asia · India
Leading Biotech Co.
Challenge
Developing a generic pen but faced severe patent barriers from originators in key markets.
Solution
Provided a complete 'Design-Around' mechanism with comprehensive FTO clearance for US and EU.
Result
Secured market entry with zero IP litigation risks.
"Their patent expertise saved us millions in potential legal risks."
Americas · Brazil
Emerging Pharma Group
Challenge
Greenfield insulin plant project with no prior drug-device combination manufacturing experience.
Solution
Full Turnkey Service: factory layout, equipment supply, validation (PQ), SOPs, and operator training.
Result
Operational in 8 months; passed ANVISA audit on first attempt.
"Drofen didn't just sell machines - they taught us how to manufacture."
Market Entry
EU & US Market Entry
Strategies
🚩
Direct Market Entry
Build your own brand and sales channels in target markets. Highest margin, full brand control.
Highest profit margin
Full brand ownership
Long-term asset value
🤝
Distributor Partnership
Partner with established local pharmaceutical distributors for rapid market access.
Faster time-to-market
Lower marketing cost
Shared regulatory risk
📄
Out-Licensing
License your product IP and manufacturing rights to major pharma companies for royalties.
Immediate revenue
Minimal commercial risk
Focus on R&D/production
Thank you for your interest in our company. For more information about our products, services and pricing, please fill out the form below and a DROFEN representative will contact you shortly.