Oral Solids

Oral-Solids

Kemwell’s state-of-the-art oral manufacturing facility in Bangalore, India, has a capacity to manufacture 5 billion tablets and capsules annually. This facility is approved by USFDA and EMA, and has been supplying products to the US and Europe since 2007. Stringent measures are streamlined via bar coding and SAP for environmental and contamination control, and materials management.

MANUFACTURING SERVICES

  • Tablets (immediate release, controlled release)
  • Capsules (immediate release, controlled release)
  • Orally Disintegrating Tablets (ODT)
  • Chewables
  • Commercial batch sizes from 5 kg to 1000 kg
  • Clinical Trial Materials (CTM) from 0.5 kg to 100 kg batch sizes
  • Comprehensive analytical services and microbiology testing

MANUFACTURING TECHNOLOGY

  • Blending and granulation:
  • Wide range of blender types and sizes
  • Wet granulation (solvent and aqueous)
  • Roller compaction (development scale)
  • 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
  • Powder fill, granule fill, pellet fill, powder and pellet fill, tablet fill, granules, pellet and tablet fill, tablets by
    count and microdosing filling capability
  • Solvent and aqueous coating capabilities
  • Coating
  • Range of tablet coating equipment capable of load sizes from 25 kg to 350 kg
  • Tablet imprinting

PACKAGING CAPABILITIES

  • Bottles
  • Blisters
  • Bulk packing

In 2006, Kemwell acquired Pfizer’s facility in Uppsala, Sweden, retaining all manufacturing contracts and 200
people on site. This facility has over 50 years of experience in supplying pharmaceutical products to countries
globally including the US, Europe and Japan. In 2010, Kemwell added another manufacturing facility in Sweden,
increasing production of tablets, capsules and suppositories.

Inspected by USFDA, EMA and Japanese regulatory authorities, our core process technologies include high shear
mixing, wet granulation, fluid bed drying, direct compacting, container blending, tablet pressing, coating and
semi-solid molding. Kemwell has facilities and personnel to perform full service in-house quality control testing,
from wet chemistry to chromatographic procedures. We have extensive experience in current cGMP guidelines and
pharmacopeias (USP/ NF, Ph. Europe/ Japan and BP).

MANUFACTURING SERVICES

  • Tablets (immediate release, controlled release)
  • Suppositories
  • Capsules
  • Clinical trial material
  • Commercial batch sizes up to 2700 kg

MANUFACTURING TECHNOLOGY

  • High shear mixing and wet granulation
  • Fluid bed drying (drying/ granulation/ coating)
  • Container blending with direct compacting
  • Tablet compacting
  • Tablet coating
  • Modern suppository line from dispensing to finished product packaging

ANALYTICAL SERVICES

  • Method development and validation (ICH)
  • Stability storage and testing
  • QP release
  • QC testing
  • Raw material and packaging component testing and release
  • Microbiological testing

PACKAGING CAPABILITIES

  • Bottles
  • Blisters
  • Bulk tablets

QP RELEASE TESTING – EU GATEWAY

Kemwell Sweden offers Qualified Person (QP) release testing for a variety of dosage forms for pharma and biotech
companies that wish to import products into the European Union (EU). Additionally, Kemwell Sweden provides QP
release for our Indian manufacturing and clinical trial material (CTM) programs that are slated for distribution in
European countries.

STABILITY SERVICES

  • IND Stability testing
  • NDA Stability testing
  • ANDA Stability testing
  • Formulation prototype stability
  • Preclinical and clinical stability
  • Method transfer and qualification
  • Stability protocol generation
  • Sample storage
  • Statistical analysis for shelf life confirmation