GMP ODF Contract Manufacturing
Clinical, pilot, and commercial batches for buccal/sublingual ODF. Full batch records and CoA.
See OEM details →GMP Oral Dissolving Film OEM — formulation to validated batches
We focus on oral dissolving films (ODF) and oral thin films: tech transfer, scale-up, GMP contract manufacturing, and packaging on qualified ODF machines.
- End-to-end: preformulation → casting → drying → slitting → die-cut → packaging
- Regulatory documentation and IQ/OQ/PQ validation protocols
- Moisture & rapid-dissolution control for buccal & sublingual ODF products
- ISO 13485-aligned QMS
- GMP-compliant facility
- Humidity-controlled suites
- HACCP for nutraceutical ODF
What we do best
Focused expertise in oral dissolving film development and production — backed by industrial ODF equipment.
Formulation R&D
API screening, film-forming polymers, plasticizers, taste-masking, and dissolution tuning.
View R&D scope →
Industrial ODF Machines
ODF casting & drying line, slitter, die-cutting, and packaging machines with spare parts.
Browse machines →ODF OEM Process at a Glance
- Tech Intake: dossier review, risk assessment, and target ODF specs.
- DoE & Trials: lab casting, thickness/moisture mapping, disintegration tests.
- Pilot Scale: parameter windowing on production-like ODF machines.
- Validation: IQ/OQ/PQ and cleaning validation per protocol.
- Commercial Run: routine GMP batches with in-process control and CoA.
Applications for Oral Dissolving Films
Ready to scale your oral thin film?
Get a fast, technical response from our ODF process engineers.
Contact the ODF Experts