Inke CNS represents one of the company’s core therapeutic areas, leveraging decades of expertise in the development and manufacture of Active Pharmaceutical Ingredients (APIs) for neurological and psychiatric disorders. Through advanced synthesis capabilities, particle engineering and a strong regulatory framework, we support pharmaceutical partners worldwide in delivering safe, effective, and high-quality treatments that improve patients’ lives.
Inke CNS
Delivering complex, high-quality APIs for neurological and psychiatric disorders, backed by decades of expertise and regulatory excellence. Explore our portfolio for the Central Nervous System and how Inke can help with your projects.
CNS Disorders: A Global Health Priority
Neurological and psychiatric disorders are among the leading causes of disability worldwide, affecting over one billion people and accounting for a growing share of global healthcare needs. Conditions such as depression, schizophrenia, Parkinson’s disease, migraine, and sleep disorders significantly impact patients’ quality of life and require long-term, reliable therapeutic solutions.
At Inke CNS, we develop and manufacture high-quality, EU-GMP–certified APIs to support pharmaceutical partners in bringing effective treatments to patients globally.
Our CNS portfolio includes key APIs such as Olanzapine, Risperidone, and Zolmitriptan, alongside a growing pipeline of innovative molecules for Parkinson’s disease, insomnia, and narcolepsy.
Advanced Containment and Micronization Expertise
Precision Manufacturing for Complex CNS
Handling CNS APIs requires precision and control. Our facilities operate under stringent containment standards (OEL 1 μg/m³), using glove-box and isolator technology to guarantee operator safety and product integrity. This approach supports full cGMP production and is complemented by advanced micronization capabilities for APIs where particle size is critical to therapeutic performance.
CNS Portfolio - APIs
Our CNS portfolio includes a wide range of APIs for neurological and psychiatric disorders, manufactured under EU-GMP standards and supported by comprehensive regulatory documentation. These molecules are designed to meet the highest quality and safety requirements, ensuring reliable supply for global pharmaceutical companies.
| THERAPEUTIC AREA | PRODUCT | INDICATION | API MICRONIZED | CEP/DMF |
| Antimigrainics | Eletriptan hydrobromideP | Migraine | ✓ | JP DMF |
| ZolmitriptanP | Migraine | ✓ | EU-US DMF | |
| Antiparkinson | Tetrabenazine | Huntington’s disease chorea and Tardive dyskinesia | EU-US DMF | |
| Antipsychotics | Asenapine maleateP | Schizophrenia and acute mania | ✓ | JP DMF |
| OlanzapineP | Schizophrenia, psychosis | EU-US-KR DMF | ||
| Quetiapine hemifumarateP | Schizophrenia, psychosis | JP-KR DMF | ||
| RisperidoneP | Schizophrenia, psychosis | ✓ | CEP/US-CN-KR DMF |
Pipeline
Beyond our established portfolio, we are actively developing next-generation CNS APIs to address unmet therapeutic needs. Our pipeline reflects Inke’s commitment to innovation, offering early-stage molecules and technical support to accelerate development and market access.
| THERAPEUTIC AREA | PRODUCT | INDICATION | SAMPLES | TECHNICAL PACKAGE | VALIDATION BATCH | DMF |
| Antiparkinson | Rotigotine | Parkinson’s disease | ✓ | Q3 2026 | Q3 2026 | Q4 2026 |
| Other disorders | Daridorexant | Insomnia | ✓ | Q1 2026 | Q2 2026 | Q4 2026 |
| Solriamfetol HCl | Narcolepsy | ✓ | Pending | Pending | Pending |
CEP = Products with Certificate of Suitability
P = Patent applications/granted patents owned by Inke
Listed products protected by valid patents are developed solely for purposes related to the development, preparation and submission of information to obtain a Marketing Authorization. In particular these products are under development for uses related to the activities stated in Art. 10.6 of Directive 2001/83/EC amended by the Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, i.e. activities carried out to obtain a Marketing Authorization. None of the products are offered for sale or supplied to countries in which they could be in conflict with valid patents.
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Regulatory Strength & Global Reach
Compliance and Market Access for CNS APIs
Our CNS portfolio is backed by strong regulatory expertise, with DMFs filed in the US, EU, JP, CN, and KR, and CEPs granted for key molecules. Combined with a proven track record of +20 years of FDA successful inspections, we ensure global compliance and provide full regulatory support to accelerate product approvals and market entry.
At Inke, CNS manufacturing goes beyond containment. We provide a fully integrated platform that ensures efficiency and compliance at every stage, from development to commercial scale:
- Advanced Synthesis & Analytical Development: Expertise in complex organic synthesis and robust analytical capabilities for CNS molecules.
- High-Containment Production Under EU-GMP: Facilities designed for stringent safety standards, guaranteeing operator protection and product integrity.
- Particle Engineering & Micronization: Specialized technologies to achieve precise particle size distribution for optimal therapeutic performance.
- Scalable Manufacturing: From milligram-scale development to commercial quantities, with seamless technology transfer and reduced time-to-market.
- Quality & Consistency: Rigorous systems ensuring reproducibility and compliance with global regulatory benchmarks.
Driving Innovation in CNS APIs
Partner with Inke for advanced solutions in central nervous system therapies.
Looking for a reliable API partner for CNS treatments?
Explore our capabilities and discover how we can accelerate your projects with global regulatory support and proven technical excellence.