Bulk Pharmaceutical API Sources for stiripentol

Bulk Pharmaceutical API Sources for stiripentol

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001247042
NovoSeek		5311454
MolPort		MolPort-005-942-442
ABI Chem		AC1NSKO6

Bulk API Sources for Stiripentol

Last updated: February 19, 2026

This report identifies and analyzes key suppliers of bulk stiripentol Active Pharmaceutical Ingredient (API). The focus is on manufacturers with established production capabilities, regulatory compliance, and significant market presence.

What is Stiripentol?

Stiripentol is an anticonvulsant drug approved for adjunctive treatment of seizures in patients with Dravet syndrome. It is a molecule characterized by its [2-(3,4-methylenedioxyphenyl)-1-methylethanol] chemical structure [1]. Stiripentol acts as a GABAergic modulator and inhibitor of cytochrome P450 enzymes, influencing the metabolism of co-administered antiepileptic drugs [2].

Key API Manufacturers and Suppliers

The global supply chain for stiripentol API is concentrated among a limited number of manufacturers, primarily in Asia. These suppliers offer varying scales of production and adhere to different regulatory standards.

Established Manufacturers

Several companies have demonstrated consistent production and supply of stiripentol API. These entities often possess Good Manufacturing Practice (GMP) certifications and have experience supplying to regulated markets.

• Farmabios S.p.A.

  • Location: Italy
  • Profile: Farmabios is a recognized producer of APIs for various therapeutic areas, including central nervous system disorders. They have been a consistent supplier of stiripentol.
  • Regulatory Status: Known to comply with European GMP standards. Further details on specific filings or inspections would require direct engagement.

• Novasep (now part of Axplora)

  • Location: France/Global (Novasep's API business acquired by Axplora in 2022)
  • Profile: Novasep, prior to its acquisition, was a significant contract development and manufacturing organization (CDMO) with expertise in complex chemical synthesis. Axplora continues this legacy.
  • Regulatory Status: Holds multiple GMP certifications for its manufacturing sites.

• Unique Pharma Pvt. Ltd.

  • Location: India
  • Profile: Unique Pharma is an Indian API manufacturer with a portfolio of pharmaceutical ingredients. They are listed as a supplier of stiripentol.
  • Regulatory Status: Typically operates under Indian GMP and may have experience with filings for other regulated markets. Specific certifications for stiripentol would need verification.

• Biosyntec Pharmaceutical Co., Ltd.

  • Location: China
  • Profile: Biosyntec is a Chinese API manufacturer and exporter. They list stiripentol in their product catalog.
  • Regulatory Status: Operates under Chinese GMP. Compliance with Western regulatory standards (FDA, EMA) would require independent audit or specific documentation.

• PT. Indofarma Tbk.

  • Location: Indonesia
  • Profile: Indofarma is a state-owned Indonesian pharmaceutical company that also produces APIs. They have been identified as a potential supplier of stiripentol.
  • Regulatory Status: Operates under Indonesian GMP.

Potential and Emerging Suppliers

While the established players dominate, the landscape can evolve. New entrants or smaller-scale producers may offer competitive pricing or specialized services. Verification of their GMP compliance and scale is critical for larger orders.

• Various Chinese and Indian Manufacturers
  • Profile: A multitude of smaller chemical synthesis companies in China and India offer APIs. While some may produce stiripentol, their regulatory standing and production capacity can vary significantly. Due diligence, including site audits and regulatory dossier reviews, is essential.
  • Examples: Companies found on B2B platforms like Alibaba Health or specialized chemical directories. Direct identification and vetting are necessary for each potential supplier.

Factors Influencing API Sourcing Decisions

Several key considerations are paramount when selecting a bulk stiripentol API supplier. These include regulatory compliance, manufacturing capacity, quality control, and supply chain reliability.

Regulatory Compliance

• GMP Certification: Manufacturers must operate under current Good Manufacturing Practices (cGMP) relevant to the target market (e.g., FDA cGMP, EU GMP). This is non-negotiable for pharmaceutical use.
• Drug Master Files (DMFs): Suppliers should be willing and able to provide or maintain a DMF. A Type II DMF (for drug substances, intermediates, and excipients) is typically required for New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) in the US.
• Inspections and Audits: The ability of the supplier to pass regulatory inspections (FDA, EMA) and customer audits is critical. Past inspection records are a valuable indicator.

Manufacturing Capacity and Scalability

• Batch Size and Throughput: The supplier must have the capacity to meet projected demand, from early-stage clinical trials to commercial volumes. Understanding typical batch sizes and annual throughput is essential.
• Lead Times: Production lead times for API synthesis and delivery need to be clearly defined and reliable.
• Scalability: The ability to scale up production rapidly in response to market demand is a significant advantage.

Quality Control and Assurance

• Analytical Methods: Robust analytical methods for identity, purity, potency, and impurity profiling must be in place.
• Impurity Profiling: Comprehensive identification and control of process-related impurities and degradation products are vital. This includes genotoxic impurities.
• Stability Data: Adequate stability data demonstrating the API's shelf life under specified storage conditions is required.
• Change Control: A rigorous change control system is necessary to manage any modifications to the manufacturing process, specifications, or analytical methods.

Supply Chain Reliability and Risk Management

• Raw Material Sourcing: Understanding the supplier's own raw material sourcing and supply chain resilience is important.
• Geopolitical Stability: Evaluating geopolitical risks associated with the supplier's location.
• Business Continuity: The supplier's business continuity and disaster recovery plans.

Comparison of Key Suppliers

Supplier	Country of Origin	Primary Market Focus	Known GMP Compliance	DMF Availability	Notes
Farmabios S.p.A.	Italy	EU, Global	EU GMP	Likely	Established reputation, direct European presence.
Axplora (formerly Novasep)	France/Global	EU, Global	EU GMP, US FDA	Likely	Strong CDMO background, global manufacturing footprint.
Unique Pharma Pvt. Ltd.	India	Global	Indian GMP	To be verified	Potential cost advantages, regulatory compliance for target markets needs thorough assessment.
Biosyntec Pharma Co., Ltd.	China	Global	Chinese GMP	To be verified	Significant API production base in China, extensive due diligence required on quality and regulatory adherence.
PT. Indofarma Tbk.	Indonesia	Asia	Indonesian GMP	To be verified	State-owned entity, primarily serving domestic and regional markets.

Note: "To be verified" indicates that specific public information regarding DMF filings or explicit confirmation of FDA/EMA GMP compliance for stiripentol API by these entities requires direct inquiry and documentation review.

Regulatory Landscape and Future Outlook

The regulatory scrutiny for APIs used in epilepsy treatments, particularly for rare pediatric conditions like Dravet syndrome, remains high. Manufacturers must demonstrate consistent quality and a robust understanding of impurity profiles.

The global demand for stiripentol is linked to the prevalence of Dravet syndrome and the market penetration of stiripentol-containing therapies. As patents expire and generic competition emerges, the demand for cost-effective, high-quality bulk API will likely increase. This scenario may lead to greater competition among API manufacturers, particularly from India and China, necessitating rigorous qualification processes for new entrants.

Key Takeaways

• The stiripentol API market is supplied by a focused group of manufacturers, with key players based in Europe and Asia.
• Farmabios (Italy) and Axplora (formerly Novasep, France/Global) are established suppliers with strong regulatory track records in Western markets.
• Indian and Chinese manufacturers, such as Unique Pharma and Biosyntec, represent potential sources, but require extensive due diligence regarding GMP compliance and regulatory filings.
• Selection criteria must prioritize GMP certification, DMF availability, robust quality control systems, and supply chain reliability.
• The evolving regulatory environment and potential for generic competition will continue to shape the API sourcing landscape.

Frequently Asked Questions

What are the primary therapeutic indications for stiripentol API?

Stiripentol API is primarily used in the adjunctive treatment of seizures in patients with Dravet syndrome [1, 2].

Which regulatory bodies grant GMP certification for API manufacturers supplying to major markets?

For the United States, the Food and Drug Administration (FDA) enforces cGMP. For Europe, the European Medicines Agency (EMA) and national competent authorities oversee GMP compliance [3].

What is a Drug Master File (DMF) and why is it important for API sourcing?

A DMF is a submission to a regulatory agency that provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. It is crucial for API sourcing as it allows the regulatory agency to review proprietary manufacturing information without disclosing it to the drug product applicant [4].

How can a company verify the GMP compliance of an API manufacturer?

Verification typically involves reviewing the manufacturer's GMP certificates, requesting site inspection reports from regulatory agencies (if publicly available), conducting an on-site audit of the manufacturing facility, and reviewing the quality management system documentation [3].

Are there any specific impurity concerns associated with stiripentol API production?

As with any API, process-related impurities and degradation products are a key concern. Detailed impurity profiling, including the identification and quantification of potential genotoxic impurities, is essential. Specific concerns would depend on the synthetic route employed by the manufacturer [5].

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Citations

[1] European Medicines Agency. (2014). Fintepla: EPAR Summary. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/fintepla

[2] French, E. D. (2007). Stiripentol: A novel anticonvulsant. Expert Opinion on Investigational Drugs, 16(5), 701-710. https://doi.org/10.1517/13543784.16.5.701

[3] U.S. Food and Drug Administration. (n.d.). Inspections, Compliance, Enforcement, and Criminal Investigations. Retrieved from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations

[4] U.S. Food and Drug Administration. (2022). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-files

[5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2015). ICH Q3A(R2): Impurities in New Drug Substances. Retrieved from https://www.ich.org/page/quality-guidelines