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Expertise /DEVELOPMENT & MANUFACTURING /Specialty APIs

SPECIALTY APIs

Since the inception of Inke, the NuPharm Group's APIs manufacturing plant, the company has
focussed on the development of products with complex synthesis and extremely high GMP requirements
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EXPERTISE IN COMPLEX SYNTHESIS

Inke’s multipurpose plant is designed to meet the stringent standards required for parenteral grade and respiratory products
  • Pharmaceutical grade (Class 10000 compliance) in final synthesis steps and packaging
  • Custom Particle Size Distribution. Process control of micronisation grades achieved through the use of proven acceptable ranges (PARs) to ensure the substance conforms to FDF formulations
  • Routine microbiological testing and strict quality control of levels of impurities, amorphous content and residual solvents
  • Critical in-process controls and cleaning process validation throughout the process to assure the highest quality standards
  • Contained equipment
  • Full testing of our products under aseptic conditions

INKE IS ABLE TO PROVIDE SOLUTIONS FOR EARLY MARKET ENTRY OPPORTUNITIES OR FOR PRODUCTS REQUIRING IN DEPTH KNOWLEDGE OF MICRONISATION TECHNIQUES

INKE

has more than 20 years of experience in differentiated micronisation capabilities
LEARN MORE ABOUT INKE