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
Q: What is the difference between an ODF film and a transdermal patch?
A: Oral Dissolving Films (ODF) are placed on or under the tongue and dissolve within seconds to minutes, delivering APIs directly through the oral mucosa or via swallowing. Transdermal patches adhere to the skin and deliver APIs through the dermal layers into systemic circulation over hours to days. Despite different delivery routes, both are manufactured using similar solvent-cast film coating processes. Huanghai's MJ150 ODF machine supports both applications on a single platform with approximately 2 working days of changeover time.
Q: What production output can I expect from a Huanghai ODF machine?
A: The MJ150 produces 20,000 films/hour at commercial scale. The MJ150-L targets R&D and pilot production at 8,000–10,000 films/hour. For fully integrated lines, pair either machine with the MJF180 automatic cutting and packaging system (11,900 films/hr) or the more affordable EZ320 (9,000 films/hr). A complete MJ150 + MJF180 line can produce over 150 million finished pouches annually on a single-shift basis. Contact us for pricing and configuration details.
Q: What drying technology does Huanghai use for ODF production?
A: Huanghai uses patented gradient hot-air drying (Patent CN201668734U), which applies a smooth progressive temperature drop rather than stepwise oven zones used by competitors. This results in more uniform film thickness, reduced edge curl, and better API distribution across the film web. An optional far-infrared heating module adds 20–30% drying efficiency for solvent-based formulations. This patented drying system is one of the key technical advantages that justifies Huanghai's position as the preferred ODF equipment supplier to Sinopharm, Shanghai Pharma, and Fosun Pharma.
Q: What are the GMP requirements for ODF production equipment?
A: ODF manufacturing equipment must comply with cGMP (21 CFR Parts 210/211) for US market products, and equivalent standards (EU GMP Annex 1, ChGMP) for other markets. Key requirements: material contact surfaces must be 316L stainless steel or equivalent; CIP/SIP capability or documented cleaning validation; data integrity controls meeting ALCOA+ principles (audit trails, access control). Huanghai ODF machines meet these standards—all product contact surfaces use pharmaceutical-grade materials, and the control system includes operator access logs and parameter change records. Request our GMP compliance documentation.
Q: Can Huanghai machines produce stripe-coated or multi-formula ODF films?
A: Yes. Huanghai holds a patent for multi-formula stripe coating (Patent CN117323228A), enabling two different API formulations to be applied side-by-side in a single coating pass. This eliminates the need for multiple coating/drying cycles when producing combination-drug ODF products. Competitors require manual multi-layer coating with drying intervals between each formula. This capability is particularly valuable for fixed-dose combination products (e.g., dual-API ODFs for cardiovascular or CNS indications) where coating efficiency directly impacts production economics.