Leading API Manufacturer

Inke is dedicated to the manufacture of Active Pharmaceutical Ingredients, boasting expertise in complex synthesis and adhering to the most stringent Good Manufacturing Practice standards.

With a legacy dating back to 1980

Inke has been at the forefront of API development, pioneering the creation and implementation of synthetic routes and polymorphs.

 

 

 

 

Uncompromising Quality Standards

Inke’s commitment to excellence is underscored by rigorous inspections, certifications, and adherence to industry-leading policies:

Inspections by regulatory authorities, including EU-GMP, FDA (most recent inspection conducted in April 2019), the Korean Agency (KFDA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

Certifications in ISO 9001 and ISO 14001, complemented by robust quality, health & safety, and environmental policies.

Our versatile multipurpose plant is engineered to meet the demanding standards required for parenteral-grade and respiratory products:

Reaction capacity of 28 m3

ensuring flexibility and scalability in manufacturing operations.

Compliance with pharmaceutical-grade standards

in final synthesis steps and packaging processes.

Custom Particle Size Distribution capabilities

enabling precise control over micronisation grades to align with Finished Dosage Form formulations

Comprehensive quality control measures

and stringent in-process controls to uphold the highest standards of product integrity and purity

At Inke, we specialize in the manufacture of active ingredients in batch sizes ranging from 1 to 300 kg. Our facility is equipped to handle a comprehensive array of organic synthesis reactions, including hydrogenation, reduction, and oxidation, operating within a temperature range of -70ºC to 200ºC and pressures from 0 to 20 bar.

With over 20 years of expertise in in-house micronisation technology, we ensure precision and excellence in every product we deliver. Our final isolation operations—including centrifuging, filtering, drying, screening, and micronisation—are conducted in controlled environment rooms, allowing us to meet the stringent quality requirements of our customers and tailor the quality of manufactured products to their specific needs.

Wide variety of chemical reaction capabilities

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 hydride