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.
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.
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 25 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.