Inke Active Pharmaceutical Ingredients for Inhalation and Central Nervous System Therapies
Inke is an exclusively held subsidiary of Neuraxpharm, which focuses on the production and development of high-quality active pharmaceutical ingredients (APIs) with compound synthesis processes for central nervous system (CNS) and inhalation therapies.
Located in Barcelona, Spain, Inke holds more than 20 years’ experience in micronisation, delivering APIs across the globe, including Europe, Japan and the US.
High-quality APIs for pharmaceutical applications
Inke has been successfully inspected by each chief global authority for a vast range of products. This enables us to hold a strong global presence with the trade of APIs to more than 30 countries worldwide.
Our manufacturing plant passed its most recent US Food and Drug Administration (FDA) approval inspection before mid-April 2019, resulting in no noted observations (Form 483) for the sixth consecutive time.
From 8-10 April 2019, the inspection was performed by the FDA inspection service, covering current Good Manufacturing Practices (cGMPs).
Through Neuraxpharm’s API manufacturing plant, Inke has a proven reputation of inspections conducted by the FDA and the Korean Food and Drug Administration (KFDA).
Technical support and regulatory affairs
Inke comprehensively manages all regulatory aspects on each country, such as preparation of Drug Master Files (DMFs), as well as preparation of Certificates of Suitability of Monographs of the EP (CEP).
We currently hold 13 DMFs in the US, 8 in Japan, 7 in Korea, and 4 in China. Furthermore, we have 9 CEPs granted in Europe.
We also provide internet protocol (IP) and patent support, as well as deficiency letters and technical assistance to our clients to implement a personal and quality service. This can be adapted according to customer requirements.
APIs for applications in respiratory therapies
Inke provides high-added-value API ingredients for use in various respiratory therapies such as Arformoterol, Formoterol, Glycopyrrolate, Revefenacin, Aclidiniumand, and Indacaterol, as well as Olodaterol, Salmeterol, Tiotropium, Umeclidinium, Vilanterol, Batefenterol, and Abediterol.
In-house micronisation expertise
With more than two decades of experience in micronisation, we offer solutions for products requiring in-depth expertise of micronisation techniques, as well as early market entry opportunities.
Our knowledge in in-house micronisation technology allows us to offer:
- Analysis, isolation, and final treatment of APIs for utilisation in respiratory therapies carried out in specialised containment facilities
- Process control of micronisation grades performed to guarantee that every API adheres to custom particle size distribution provisions
- Regulation of amorphous content and applicable constraints for particle size stability for appropriate formulation purposes
- Technical support and customised products
- Various patent applications
Inke cultivates, patents and applies innovative polymorphic forms and salts in individual synthesis routes for the creation of active substances.
Given the particular requirements for these products, this obligation has allowed us to increase the level of regulatory and technical collaboration with our clients.