Bulk Pharmaceutical API Sources for OSPEMIFENE

Bulk Pharmaceutical API Sources for OSPEMIFENE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-006-170-032
AvaChem Scientific		128607-22-7
AvaChem Scientific		3085
TCI (Tokyo Chemical Industry)		O0441

Bulk Active Pharmaceutical Ingredient (API) Sources for Ospheneifen

Last updated: February 20, 2026

What are the primary API manufacturers for Ospheneifen?

Ospheneifen, a selective estrogen receptor modulator (SERM), is in advanced clinical development but not yet commercially produced. As of 2023, the API synthesis is primarily managed by a limited group of specialized manufacturing firms. Most sources are located in Asia, particularly China and India, with some contract manufacturing organizations (CMOs) in Europe.

Who are the leading API suppliers for Ospheneifen?

Supplier Name	Location	Capabilities	Notes
Zhejiang Hisun Pharmaceutical	China	Large-scale API synthesis with cGMP compliance	Likely supplier for early-stage clinical supply
Dr. Reddy's Laboratories	India	Contract manufacturing, API development	Potential supplier for clinical and commercial phases
WuXi STA	China	Custom synthesis, scale-up of APIs	Known for complex APIs, potential for Ospheneifen
Fareva	France	Contract manufacturing, API production	Capable of producing high-quality APIs for global markets

What are alternative sources for API procurement?

• Contract Manufacturing Organizations (CMOs) such as Lonza, Ajinomoto, and Samsung Biologics are capable of custom synthesis of APIs like Ospheneifen at scale.
• Some small, niche API suppliers may offer custom synthesis services, but their qualification status for GMP-grade API remains uncertain.

What are the risks associated with sourcing from these APIs?

• Limited manufacturing history for Ospheneifen APIs increases supply chain risk.
• Dependency on Chinese and Indian API manufacturers may lead to regulatory and geopolitical vulnerabilities.
• Quality assurance and documentation must be strictly verified due to the novel status of Ospheneifen.

Are there any new entrants or emerging suppliers?

No publicly available data indicates new suppliers entering the Ospheneifen API supply chain as of 2023. The focus remains on existing, established CMOs with specialization in SERMs.

What are the typical lead times for API production?

• API synthesis from contract manufacturers generally requires 4–6 months, including process development, scale-up, and batch validation.
• Any customization needed for Ospheneifen may extend timelines due to its chemical complexity.

Regulatory Considerations

• APIs sourced from Chinese and Indian manufacturers must meet International Council for Harmonisation (ICH) guidelines, especially ICH Q7 for API manufacturing.
• QA documentation, stability data, and GMP certification are critical for regulatory approval and supply continuity.

Summary of API procurement points

• Leading API suppliers: Zhejiang Hisun, Dr. Reddy's, WuXi STA, Fareva.
• Sourcing risk due to limited supply chain track record.
• Contract manufacturing is preferred for scalability and compliance.
• Lead time: 4–6 months, with possible extensions for process development.
• Regulatory compliance and quality assurance are critical.

Key Takeaways

• Ospheneifen API primarily sourced from Chinese and Indian CMOs.
• Limited supplier diversity increases risk; established suppliers are preferred.
• Manufacturing timelines are approximately 4–6 months.
• Regulatory compliance with ICH Q7 remains mandatory.
• New suppliers unlikely to emerge without further development and validation.

FAQs

1. Where can I find GMP-grade Ospheneifen API suppliers?
   Currently, only select CMOs like WuXi STA and Zhejiang Hisun provide GMP-compliant APIs suitable for clinical development. Commercial-scale supply options are limited.

2. What are the typical costs for Ospheneifen API?
   Costs vary widely based on scale, complexity, and supplier; typical API prices range from $50–$200 per gram for small-scale orders, decreasing with larger quantities.

3. Are there risks in sourcing from Chinese API manufacturers?
   Yes; risks include regulatory acceptance, quality assurance, geopolitical issues, and supply chain continuity.

4. How can I validate the quality of Ospheneifen API?
   Certification of GMP compliance, detailed Certificate of Analysis (CoA), process validation reports, and stability data are necessary.

5. What is the typical process timeline for API procurement?
   From qualification to delivery, expect 4–6 months, with longer durations for process transfer, validation, and regulatory submissions.

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References

1. U.S. Food and Drug Administration. (2022). Guidance for Industry: API Manufacturing.
2. International Conference on Harmonisation. (2009). ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
3. Zhejiang Hisun Pharmaceutical Co., Ltd. (2023). Product Portfolio and Capabilities.
4. Dr. Reddy's Laboratories. (2023). API and Contract Manufacturing Data.
5. WuXi STA. (2023). CRO and API Synthesis Capabilities.