Therapeutic Area
Neurology CDMOs
Compare CDMOs with neurology and CNS drug manufacturing experience for small molecules, biologics, and gene therapies targeting neurological conditions. Filter by modality, containment, and scale.
135 companies listed
About Neurology Drug Manufacturing
Neurology manufacturing spans a wide range of modalities: small molecule CNS drugs (antiepileptics, antidepressants, dopamine modulators), biologics (anti-amyloid antibodies for Alzheimer's, anti-CGRP for migraine), gene therapies (AAV vectors for spinal muscular atrophy, Parkinson's), and advanced delivery systems (intrathecal pumps, nasal sprays for CNS penetration).
Controlled substances are common in this space. Many neurological drugs -- benzodiazepines, opioid-based pain medications, stimulants for ADHD -- fall under DEA scheduling. CDMOs handling Schedule II-V compounds need DEA registration, vault storage, meticulous chain-of-custody documentation, and annual quota management. Not all CDMOs have this licensure.
Blood-brain barrier penetration drives formulation innovation. For drugs that struggle to cross the BBB, CDMOs with experience in nanoparticle formulations, lipid-based delivery systems, intranasal devices, or intrathecal formulations provide a competitive advantage. Gene therapy vectors for neurological targets (AAV9 for spinal cord, AAV-PHP.eB for brain) require specialized viral vector manufacturing capabilities.
Companies (135)
Novartis Contract Manufacturing
Austria
Novartis Contract Manufacturing is the CDMO arm of Novartis, offering fully integrated end-to-end manufacturing solutions across biologics (mammalian up to 15,000L, microbial up to 13,000L), small molecules (API to fill & finish), cell & gene therapy (CAR-T, AAV, LV), xRNA/LNP/pDNA, and comprehensive fill & finish services. The operation spans multiple state-of-the-art facilities across Austria, Switzerland, Slovenia, Belgium, France, Singapore, and the United States, with 107 FDA inspections and 27 FEI registrations.
Small Molecule APISmall Molecule Drug ProductOral Solid Dose
Novugen Pharma
Malaysia
Novugen Pharma is a Malaysian pharmaceutical company and CDMO subsidiary of UAE-based SciTech International, providing vertically integrated API and finished dosage form development and manufacturing. The company has USFDA-approved facilities including a dedicated oncology manufacturing plant. Novugen achieved zero Form 483 citations from USFDA and holds Halal pharmaceutical certification.
Frequently Asked Questions
Why do neurology CDMOs need DEA licensing?+
Many neurological drugs are controlled substances under the Controlled Substances Act. Benzodiazepines (Schedule IV), certain pain medications (Schedule II-III), and stimulants (Schedule II) require DEA-registered manufacturing facilities with specific security measures: vault or cage storage, electronic access logging, perpetual inventory systems, annual DEA audits, and production quotas allocated by the DEA. CDMOs without this infrastructure cannot manufacture these compounds.
What delivery systems are important for CNS drugs?+
CNS drugs face the blood-brain barrier challenge. Delivery innovations include: intranasal formulations (bypassing BBB via olfactory/trigeminal pathways), intrathecal formulations (direct CNS delivery via spinal injection), nanoparticle carriers (lipid nanoparticles, polymer nanoparticles for BBB transcytosis), and implantable devices (programmable pumps for continuous delivery). Each requires specialized formulation and device assembly capabilities from the CDMO.
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