Oral Solids

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:
    1. Wide range of blender types and sizes
    2. Wet granulation (solvent & aqueous)
    3. Roller compaction
    4. Particle sizing
    5. Directly-compressible formulation
  • Compression
    1. Range of compression equipment with outputs from 15,000 to 300,000 tablets per hour
  • Encapsulation
    1. Range of capsule filling equipment with tooling from size 4 through to size 00
    2. Fully automated capsule weight-check
  • Coating
    1. Range of tablet coating equipment capable of load sizes from 25kg to 350kg
  • Tablet Imprinting