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EXPERTISE / MANUFACTURING ASSETS

MANUFACTURING ASSETS

Inke’s manufacturing plant specialises in the development of APIs with complex synthesis and extremely high GMP requirements

INKE

has been developing, patenting and implementing its own synthetic routes and polymorphs for the manufacturing of active pharmaceutical ingredients since 1980

Manufacture of active ingredients

CAPABILITIES

In-house micronisation technology

  • Manufacture of active ingredients in batches ranging from 1 to 300 kg
  • Ability to perform all types of organic synthesis reactions (hydrogenation, reduction, oxidation, etc.) within a temperature range from -70ºC to 200ºC and pressures from 0 to 20 bar
  • Over 20 years' experience in in-house micronisation technology    
  • Final isolation operations (centrifuging, filtering, drying, screening, micronisation and supplying) are performed in controlled environment rooms and allow the quality of the manufactured products to be adjusted to customers' needs

INSPECTIONS,
CERTIFICATIONS & POLICIES

Inspections:
EU-GMP
FDA (last inspection April 2016)
Korean Agency (KFDA)

Certifications:
ISO 9001
ISO 14001

INKE inspections

BROAD RANGE OF
CHEMICAL REACTIONS

REACTIONS

· Organometallic chemistry
· Grignard reactions
· Organolithium
· Cyclization
· Friedel-Crafts

· High temperature reactions
· Hydrogenation (catalytic)
· Oxidation (H2O2, peracid...)
· Reduction with hydrides

HANDLING OF HAZARDOUS CHEMICALS

· Alkylating agents
· Bromine
· Chlorinating agents (SO2Cl2, SOCl2, POCl3, PCl5)
· Hydrochloric acid gas

· Lewis acids (BF3, ACl3...)
· Metal hydrides



INDEPENDENT AREAS


Charging, Sampling, Discharging, Drying, Sieving, Micronising, Milling and Packaging operations are carried out under
environmentally controlled conditions (ISO 7) to keep contamination risks under control

 APIs with complex synthesis and extremely high GMP requirements

EXPERTISE IN COMPLEX SYNTHESIS

Inke’s multipurpose plant is designed to meet the stringent standards required for parenteral-grade and respiratory products
  • MANUFACTURING_ASSETS_METAS_SYNTHESIS_ALT_LIST01 Reaction capacity 25 m3
  • MANUFACTURING_ASSETS_METAS_SYNTHESIS_ALT_LIST01 Pharmaceutical grade (Class 10000 compliance) in final synthesis steps and packaging
  • MANUFACTURING_ASSETS_METAS_SYNTHESIS_ALT_LIST02 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
  • MANUFACTURING_ASSETS_METAS_SYNTHESIS_ALT_LIST03 Routine microbiological testing and strict quality control of levels of impurities, amorphous content and residual solvents
  • MANUFACTURING_ASSETS_METAS_SYNTHESIS_ALT_LIST04 Critical in-process controls and cleaning process validation throughout the process to assure the highest quality standards
  • MANUFACTURING_ASSETS_METAS_SYNTHESIS_ALT_LIST05 Contained equipment
  • MANUFACTURING_ASSETS_METAS_SYNTHESIS_ALT_LIST06 Full testing of our products under sterile conditions