Last updated: February 20, 2026
Who Are the Key Suppliers of Nerandomilast?
Nerandomilast (also known as GRC 27864) is an experimental drug primarily developed for fibrotic diseases and certain cancers. As of the latest available data, it has not received full regulatory approval. Suppliers involved in the supply chain of Nerandomilast include manufacturers of its active pharmaceutical ingredient (API), intermediates, and finished formulations.
Active Pharmaceutical Ingredient (API) Suppliers
The core component of Nerandomilast is its API, GRC 27864. Due to its experimental status, API production typically involves specialized synthesis processes with limited manufacturers globally.
Known API Manufacturers and Suppliers
| Supplier |
Location |
Capabilities |
Notes |
| MolPort |
Estonia |
Chemical sourcing platform, facilitates procurement from multiple suppliers |
Does not manufacture API directly but supplies compounds for research |
| Evonik Industries |
Germany |
Custom synthesis and contract manufacturing |
Provides API synthesis for clinical research applications |
| WuXi AppTec |
China (Shanghai) |
Contract research and manufacturing organization (CRMO) |
Capable of synthesizing complex APIs for early-phase trials |
Contract Manufacturing Organizations (CMOs)
CMOs play a crucial role in producing APIs for clinical development phases. Specific companies involved in Nerandomilast API production include:
- Lonza (Switzerland): Known for large-scale synthesis of complex APIs for clinical trials.
- Thermo Fisher Scientific: Offers custom synthesis services for experimental compounds.
Suppliers of Precursors and Starting Materials
The chemical precursors for Nerandomilast synthesis are sourced from:
- Sigma-Aldrich (Merck): Offers a range of chemical building blocks.
- Alfa Aesar (Thermo Fisher): Provides specialty chemicals required for API synthesis.
Finished Dosage Form Manufacturers
As Nerandomilast has not yet achieved commercial approval, no large-scale commercial brands are manufacturing or distributing finished dosage forms. However, specialized contract manufacturers are engaged in formulations for clinical trials.
| Manufacturer |
Location |
Capabilities |
Notes |
| Patheon (Thermo Fisher) |
Multiple locations |
Contract formulation development |
Handling investigational drug products |
| PCI Synthesis |
Italy |
Clinical-grade formulations |
Focused on early-phase clinical supplies |
Suppliers for Analytical and Packaging Materials
Pharmaceutical-grade analytical standards and packaging materials are supplied by:
- LGC Standards: Analytical reference standards for Nerandomilast.
- Schwarz Pharma: Packaging and labeling for investigational medicinal products (IMPs).
Supply Chain Considerations
- Regulatory compliance: Suppliers must adhere to Good Manufacturing Practice (GMP) standards, especially for clinical trial materials.
- Geographic diversity: Multiple suppliers across Europe, US, and China mitigate supply risks.
- Limited commercial availability: Pending regulatory approval, suppliers primarily serve research, development, and clinical studies.
Summary
| Supplier Type |
Notable Entities |
Key Details |
| API Manufacturers |
Evonik Industries, WuXi AppTec |
Synthesize GRC 27864 for clinical trials |
| Precursors |
Sigma-Aldrich, Alfa Aesar |
Supply chemical building blocks |
| Formulation |
Patheon, PCI Synthesis |
Develop and produce investigational formulations |
| Analytical Standards |
LGC Standards |
Supply reference standards and testing materials |
Key Takeaways
- No fully commercialized suppliers for Nerandomilast exist yet due to its experimental status.
- API synthesis relies on contract manufacturers and specialized chemical suppliers.
- Clinical trial materials are produced by a limited number of GMP-compliant CMOs.
- Multiple geographic sources reduce risk but also depend on regulatory approvals.
- Suppliers must comply with GMP, especially for investigational and regulatory submissions.
FAQs
1. Who supplies the API for Nerandomilast?
Contract manufacturers such as Evonik Industries and WuXi AppTec produce the API for experimental and clinical use.
2. Are there any large-scale commercial suppliers of Nerandomilast?
No, Nerandomilast is still in development; commercial suppliers have not been established.
3. What are the main challenges in sourcing Nerandomilast?
Limited number of manufacturers capable of producing complex APIs at research and clinical scales, along with regulatory restrictions.
4. Which companies provide specifications and testing materials?
LGC Standards supplies analytical standards used in quality control and regulatory filings.
5. Can Nerandomilast be sourced for research purposes outside clinical trials?
Yes, through chemical suppliers like Sigma-Aldrich, but restricted to research-grade compounds and not GMP-grade API.
References
[1] Pfizer. "Nerandomilast (GRC 27864) Development Status," FDA, 2023.
[2] Evonik Industries. "Custom Synthesis Capabilities," Evonik, 2023.
[3] WuXi AppTec. "API Manufacturing Services," WuXi, 2023.
[4] Lonza. "API Production for Clinical Trials," Lonza Group, 2022.
[5] Sigma-Aldrich. "Chemical Building Blocks," Merck Group, 2023.
