DROFEN MACHINERY: Turnkey System Provider for Injection Pen Assembly & PFS Filling
DROFEN MACHINERY is a turnkey system provider delivering automated injection pen assembly lines and pre-filled syringe (PFS) filling systems. Founded in 2009 and headquartered in Shanghai, we serve CDMOs, biosimilar companies, and pharmaceutical manufacturers scaling up GLP-1 and insulin injectable production worldwide.
What sets us apart: we deliver the injection pen device and the assembly equipment as one integrated system. Because the pen and the line are engineered together, every process parameter - torque, stroke, dosing accuracy - is pre-validated as a matched pair. Clients eliminate 6-12 months of compatibility testing, avoid multi-vendor coordination risk, and achieve commercial production faster.
This is the core of our turnkey model: not selling machines, but delivering validated production capability - one partner from device selection to commercial launch.
Vision
To be the first-choice turnkey system provider for pharmaceutical companies and CDMOs launching injectable pen and PFS products - recognized for engineering precision, regulatory readiness, and single-source project delivery.
Mission
To help pharmaceutical manufacturers move from concept to validated commercial production faster by delivering integrated turnkey systems - assembly equipment, pen device platform, and complete regulatory validation - from a single source.
Turnkey Scope: What DROFEN MACHINERY Delivers
DROFEN MACHINERY is a turnkey system provider. Our delivery goes beyond equipment to include the pen device platform and complete regulatory validation - eliminating multi-vendor coordination and accelerating time to market.
►Injection Pen Assembly Lines (160 Pens/Min): Both pre-assembly equipment (8-13 components, vibratory feeding, RFID pallet tracking) and final assembly lines (labeling, 100% inline functional testing, packaging). Cam-driven continuous-motion architecture with 130-pallet transport, Keyence/Cognex vision inspection, and Burster/Kistler force-displacement monitoring on every pen.
► PFS Filling Lines (220 Syringes/Min): Complete 6-station turnkey production lines for PP saline flush syringes - from NaCl preparation through aseptic filling (±0.5% accuracy, ISO Class 5 isolator), AI-powered light inspection (99.5% detection rate, ≥50 µm), serialization, and pillow packaging. Contractual >85% OEE guarantee.
►Pen Device Platform: Certified injection pen designs (disposable and reusable) matched to our assembly equipment, with FTO analysis and regulatory dossier for clean market entry. Eliminates device-equipment mismatch risks that cost multi-vendor projects 6-12 months.
►Regulatory & Validation Package: Complete DQ/IQ/OQ/PQ documentation, Challenge Parts protocol, GAMP5 CSV, 21 CFR Part 11 compliant SCADA. Aligned with FDA 21 CFR Part 4/11, EU GMP Annex 1, ISO 11608, and WHO GMP. Structured for regulatory submission in any market.
►Single-Source Accountability: One contract, one project manager, one timeline. Equipment + pen device platform + validation delivered as an integrated system - zero multi-vendor finger-pointing during commissioning and validation.
Global Presence
DROFEN MACHINERY is headquartered in Shanghai with dedicated local teams in key markets. Installed base spans India, Southeast Asia, the Middle East, and Latin America. On-site FAT/SAT execution, operator training, and ongoing technical support available in all served regions.
For multinational projects, our local engineering teams improve decision speed, reduce communication delays, and support practical follow-up from technical discussion to validated production.
Global Presence
DROFEN MACHINERY operates local engineering teams across key markets enabling faster project communication and smoother execution coordination. For multinational projects, this improves decision speed, reduces communication delays, and supports practical follow-up during implementation.
Why Choose DROFEN MACHINERY
These advantages define how DROFEN MACHINERY delivers turnkey projects for CDMOs and pharmaceutical manufacturers.
Single-Source Turnkey System: Pen device platform + assembly equipment + regulatory validation from one provider. One project manager, one timeline, zero multi-vendor coordination risk.
Competitive Total Cost of Ownership: European-level engineering quality at a highly competitive TCO. Cam-driven architecture means lower maintenance vs. multi-servo systems. 10-year spare parts guarantee.
Accelerated Time to Market: Proven machine platforms (160 PPM) and ready-to-use pen designs with existing regulatory dossiers. Skip years of device R&D - concept to validated production faster.
Global Regulatory Compliance: FDA 21 CFR Part 4/11, ISO 11608, EU GMP Annex 1, WHO GMP, CDSCO - complete DQ/IQ/OQ/PQ documentation structured for regulatory submission in any market.
One Partner, One System, One Validation - From Concept to Commercial Launch
DROFEN MACHINERY is a turnkey system provider delivering automated injection pen assembly lines and pre-filled syringe (PFS) filling systems. We serve CDMOs and pharmaceutical manufacturers scaling up GLP-1 and insulin injectable production - delivering equipment, pen device platform, and regulatory validation as one integrated system.