Pharma-Grade ODF Manufacturing
Pharma-Grade ODF Solutions: From R&D to Scalable Manufacturing
HUANGHAI empowers pharmaceutical and nutraceutical brands to develop high-performance oral dissolvable films (ODFs) — including complex, multi-ingredient, and regulatory-compliant formulations — through an integrated approach combining formulation support, patented coating technology, and scalable GMP manufacturing systems.
Why It Matters
Oral dissolvable films are transforming drug delivery and functional supplements. But not all ODF systems are created equal. While many machines are designed for food-grade products, pharma-level ODFs demand higher standards: precise formulation control, validated process parameters, and compliance with GMP, FDA, and CE requirements.
What Makes HUANGHAI Different
- Pharma-Grade Engineering: All systems are built for pharmaceutical use — with hygiene, traceability, and validation in mind.
- Multi-API & Layered Formulations: Support for complex drug or functional supplement combinations, including bilayer and fast-dissolving films.
- Formulation Co-Development: Work with our R&D team to co-create stable, scalable formulations from pilot to production.
- Global Regulatory Readiness: Designed for compliance with GMP, CE, and FDA standards.
Our Core Capabilities
1. Multi-Formula Coating Technology →
Our patented dual-lane coating design allows simultaneous application of two formulations with high precision. This is ideal for bilayer films, combination drugs, or separating pH-sensitive actives.
Learn how it reduces material waste and increases efficiency →
2. Complete ODF Manufacturing Line →
From solution preparation, precision coating, drying, to slitting and packaging — our modular system covers every critical step with traceable automation.
Explore each module in detail →
3. Formulation & Scale-Up Support →
We don’t just sell machines — we help build products. Our team provides pilot line development, tech transfer support, and formulation optimization to help you launch successfully.
Discover how we bridge R&D and commercial production →
Application Scenarios
- Prescription ODFs with multi-active APIs (e.g. combination therapy for cold, pain, allergy, etc.)
- Nutraceutical films with functional claims (e.g. melatonin + magnesium sleep aid)
- Children’s medicine or vitamin delivery
- Bi-layer or fast-dissolving formulations needing pH-separation or taste-masking
Ready to Build Your Next ODF Product?
Whether you're a pharmaceutical company launching a novel delivery system, or a nutraceutical brand expanding into premium formats, HUANGHAI is your full-stack partner — from formula to factory.
Frequently Asked Questions
What is the difference between an ODF film and a transdermal patch?
Oral dissolving films (ODF) dissolve on or under the tongue within seconds to minutes; transdermal patches stick to the skin and release the API over hours to days. Both are made by solvent-cast film coating, and the MJ Pro coating platform can be built for either — the application is set before the machine is manufactured.
What output can I expect from Huanghai ODF machines?
MJ150-RD about 1,200 films per hour for formulation screening; MJ150-Lab 8,000–10,000 films per hour for pilot and clinical batches; MJ150 about 30,000 films per hour (Gen I) for commercial production. For packaging, the MJ180 cuts and packs about 11,900 films per hour (Gen I); the EZ320 (about 9,000 films per hour) is for food-grade films only.
What drying technology is used?
The MJ150 production line uses a hot-air parallel-flow drying tunnel based on Academician Hou Huimin's patent CN201668734U. The MJ150-RD and MJ150-Lab use oven drying.
Can Huanghai machines coat multi-formula (striped) films?
Yes. Huanghai's patent CN117323228A covers stripe coating that applies two formulations side by side in one pass, useful for fixed-dose combination films.