Oral Solids
Development:
Kemwell’s development team offers experienced solid dosage form support from Phase I (first-in-human) development to commercial scale up. To convert your compound into a finished product, we offer a wide range of services: formulation development, process development, analytical development, method validation, clinical trial material (CTM) manufacture, scale-up, process validation, and ICH stability studies.
We can support your outsourcing needs from proof-of-concept, to clinical supply manufacture, to dossier preparation & regulatory filing, guaranteeing quality, speed and value.
- Formulation development
- Proof of Concept Studies
- Drug & Container Compatibility Studies
- Flavoring/taste masking
- Controlled Release development (CR, SR, MR, Pulse)
- Bioavailability optimization
- Process development
- Analytical Development & Validation
- Stability Testing
Manufacture:
Kemwell Oral Solids Unit (OSU) in India & Sweden are fully cGMP commercial manufacturing facilities, meeting USFDA and EMEA requirements. Total capacity for 2 to 5 billion tablets annually. Kemwell currently ships to over 80 markets worldwide, including USA & EU.
- Tablets – Coated/Uncoated
- Capsules
- Orally Disintegrating (ODT)
- Effervescent (tablets, powders)
- Chewable
- Batch sizes 5 kg to 1000 kg
- Clinical Trial Materials – 0.5 kg-100 kg batch sizes
Manufacturing Technology:
- Blending and Granulation:
- Wide range of blender types and sizes
- Wet granulation (solvent & aqueous)
- Roller compaction
- Particle sizing
- Directly-compressible formulation
- Compression
- Range of compression equipment with outputs from 15,000 to 300,000 tablets per hour
- Encapsulation
- Range of capsule filling equipment with tooling from size 4 through to size 00
- Fully automated capsule weight-check
- Coating
- Range of tablet coating equipment capable of load sizes from 25kg to 350kg
- Tablet Imprinting