Proven Quality Track-Record

At Inke, quality assurance isn’t just a process – it’s our unwavering commitment to delivering products of the highest standard to our customers worldwide.

With a track record of successful inspection by every major global authority, including the US Food and Drug Administration, we have established ourselves as a trusted and reliable partner in the pharmaceutical industry.

Driven quality throughout the organisation

Quality is ingrained in our culture at Inke, with 37% of our employees actively involved in quality activities.

We maintain rigorous quality control measures, including an Electronic Document Management System, a comprehensive GMP training programme, and a robust self-inspection programme, ensuring that every aspect of our operations adheres to the highest standards of excellence.

“Even when clients experienced technical or testing issues on their end, these were not related to the quality of Inke’s APIs. This consistent quality and reliability are why I confidently rate Inke’s API quality at the highest level.”

Quality Driven Organization

Periodic Inspections and Satisfactory Results

Inke’s plant has received periodic inspections from worldwide health authorities with satisfactory results since 2002. Our commitment to maintaining the highest standards of quality and compliance has consistently been validated by these authorities.

Continuous Supply of High-Quality APIs

Since our establishment in 1980, Inke has been dedicated to the continuous supply of the highest quality active pharmaceutical ingredients. Our long-standing reputation in the industry is built on decades of reliable and superior product delivery.

FDA Inspections

Inke has been inspected six times by the FDA, with the most recent inspection conducted in 2019, which underscores our rigorous adherence to regulatory standards and exceptional operational practices.

GMP and ISO 9001 Certifications

Our plant holds GMP certification from the Spanish Health Authorities, demonstrating our compliance with Good Manufacturing Practices. Additionally, we are certified under ISO 9001, reflecting our commitment to quality management systems and consistent product excellence.

ISO 14001 Environmental Management Certification

Inke is proud to be accredited with the UNE EN ISO 14001 certificate in environmental management. This certification highlights our dedication to minimizing our environmental impact and implementing sustainable practices in our operations.