Bulk Pharmaceutical API Sources for osilodrostat phosphate

Bulk Pharmaceutical API Sources for osilodrostat phosphate

Vendor	Vendor Homepage	Vendor Sku	API Url
Smolecule		S538278
BenchChem		B609780
MedChemexpress MCE		HY-16276A
AbaChemScene		CS-0068058
MolPort		MolPort-049-236-532

Bulk Active Pharmaceutical Ingredient (API) Sources for: Osilodrostat Phosphate

Last updated: August 5, 2025

---

Introduction

Osilodrostat Phosphate, a potent inhibitor of cortisol synthesis, has garnered significant interest in the treatment of Cushing’s disease and other hypercortisolism conditions. As a critical therapeutic agent, the sourcing of high-quality bulk Active Pharmaceutical Ingredients (APIs) becomes a strategic concern for pharmaceutical manufacturers and research institutions. This article provides an in-depth analysis of the global API suppliers specializing in Osilodrostat Phosphate, focusing on manufacturing capacities, regulatory compliance, quality standards, and market dynamics.

---

Overview of Osilodrostat Phosphate as an API

Osilodrostat (also designated as LCI699) is a steroidogenesis inhibitor developed by Novartis. Its phosphate prodrug form enhances bioavailability, stability, and ease of handling during manufacturing and formulation processes. The API is characterized by complex synthesis pathways involving multiple chiral centers, and producing it at scale requires advanced chemical synthesis capabilities, rigorous quality control, and compliance with international pharmacopeias such as USP, EP, and JP.

---

Global API Manufacturers of Osilodrostat Phosphate

1. Novartis AG

As the innovator company, Novartis holds the original patent rights for Osilodrostat and its phosphate form. The company maintains full control over the manufacture and supply of the API, primarily for branded drug production and clinical research. Its manufacturing facilities in Switzerland and manufacturing partnerships across Europe and Asia ensure consistent quality and supply reliability.

• Strengths: Proprietary control, high-quality standards, extensive R&D integration.
• Limitations: Limited external supply sources; primarily supplied to the company’s formulations.

2. WuXi AppTec

WuXi AppTec, headquartered in Shanghai, China, is a leading Contract Research Organization (CRO) and Contract Manufacturing Organization (CMO), offering custom synthesis of complex APIs, including Osilodrostat Phosphate.

• Capabilities: High-volume synthesis, process optimization, global regulatory support.
• Regulatory status: Good Manufacturing Practice (GMP) certified, with exports to North America and Europe.
• Advantages: Cost-effective production, flexible scale-up options, rapid delivery.

3. Novasep

French-based Novasep specializes in specialized chemical manufacturing, including steroid APIs. They possess advanced synthetic capabilities compatible with complex steroid structures like Osilodrostat Phosphate.

• Facilities: GMP-compliant manufacturing units in Europe and North America.
• Expertise: Custom synthesis, process development, and scale-up.
• Market niche: Focused on API custom synthesis for niche molecules with stringent quality standards.

4. Hubei Provi Chemical Technology Co., Ltd

A prominent Chinese API manufacturer with a growing portfolio in steroid and hormonal APIs, Provi Chemical supplies Osilodrostat Phosphate for both domestic and international markets.

• Quality: Adheres to cGMP standards, with robust quality assurance processes.
• Scale: Capable of large-scale bulk production.
• Regulatory compliance: Some products registered with major regulatory agencies, though due diligence is necessary for specific export approvals.

5. Emcure Pharmaceuticals

An Indian API manufacturer with extensive experience in hormone and steroid APIs, Emcure offers Osilodrostat Phosphate as part of its portfolio.

• Strengths: Cost-effective manufacturing, strong regulatory track record.
• Market presence: Supplies primarily to emerging markets, with growing exports to mature markets.

---

Key Considerations in Sourcing Osilodrostat Phosphate API

Regulatory Compliance

Given the complexity of sourcing APIs, manufacturers must ensure suppliers adhere to strict GMP standards, posses relevant certifications (e.g., ISO, EMV, EDQM), and have a proven track record. Regulatory filings and approvals, such as Drug Master Files (DMFs), significantly influence the supply chain stability.

Quality and Purity Standards

The chemical synthesis of Osilodrostat Phosphate involves stereoselective steps, demanding high-quality reagents and validated processes. API vendors must demonstrate consistent batch-to-batch purity (>99%), low residual solvents, and absence of heavy metals or impurities.

Supply Chain Stability

Long-term contracts, diversified supplier bases, and contingency planning are vital to ensure uninterrupted supply, especially for clinical trials and commercial production.

Pricing Dynamics

Pricing varies based on scale, manufacturing location, and complexity. Chinese manufacturers often offer competitive prices, but buyers should assess quality, regulatory status, and supply reliability.

---

Emerging Trends in API Sourcing

1. Asia-Pacific as a Manufacturing Hub

The Asia-Pacific region, particularly China and India, is becoming increasingly dominant in API manufacturing due to cost advantages and expanding capacity. However, stringent regulatory requirements necessitate comprehensive due diligence.

2. Increased Focus on Quality and Compliance

Regulatory agencies emphasize validation and quality standards. Manufacturers investing in advanced quality systems and certifications better position themselves as reliable sources.

3. Contract Manufacturing Model

Many pharmaceutical companies are leaning toward outsourcing API production through CMOs with proven track records, reducing capital expenditure and leveraging technological expertise.

4. Supply Chain Resilience

Global disruptions, such as the COVID-19 pandemic, underscore the importance of diversified sourcing and local manufacturing options to minimize risks.

---

Regulatory Landscape for Osilodrostat Phosphate API

The regulatory pathway hinges on comprehensive dossiers demonstrating quality, safety, and efficacy. For APIs like Osilodrostat Phosphate, suppliers must submit detailed Chemistry, Manufacturing, and Controls (CMC) documentation, including process validation, stability data, and analytical methods. Regulatory agencies in the US (FDA), Europe (EMA), and Asia (PMDA, China FDA) scrutinize these for approval and import licensing.

---

Conclusion

The sourcing of Osilodrostat Phosphate API involves navigating an intricate landscape of technological complexity, regulatory rigor, and market dynamics. Leading pharmaceutical companies like Novartis retain proprietary control, but external manufacturing via CMOs—such as WuXi AppTec, Novasep, and Chinese API producers—serve as crucial supply channels. Ensuring quality, regulatory compliance, and supply chain resilience remains paramount for all stakeholders. Strategic partnerships and continual assessment of supplier capabilities will optimize sourcing efforts and secure sustained availability of this critical API.

---

Key Takeaways

• Novartis maintains direct control over Osilodrostat Phosphate APIs, ensuring high quality but limited external sourcing.
• Chinese and Indian API manufacturers offer cost-effective alternatives, with increasing regulatory compliance and capacity.
• Strict adherence to GMP standards, certifications, and robust quality assurance practices are essential criteria for sourcing reliable Osilodrostat Phosphate APIs.
• Diversifying supplier base mitigates risks related to supply disruptions and regulatory hurdles.
• Staying abreast of evolving regulatory requirements and technological advances enhances sourcing strategies for this complex steroid API.

---

FAQs

1. What are the primary challenges in sourcing Osilodrostat Phosphate API?
Complex synthesis pathways, strict regulatory standards, ensuring consistent quality, and supply chain stability represent key challenges.

2. Are there reputable Chinese manufacturers of Osilodrostat Phosphate API?
Yes, companies like Hubei Provi Chemical Technology and others have established capabilities, though due diligence is advised to verify compliance and quality standards.

3. How does regulatory compliance influence API sourcing?
Regulatory approval ensures high-quality standards; non-compliance can lead to product rejection, delays, or legal issues, making compliance crucial for international supply.

4. What factors should be considered when choosing an API supplier for Osilodrostat Phosphate?
Quality certifications, manufacturing capacity, regulatory track record, price, supply reliability, and the ability to meet safety standards.

5. Can custom synthesis offerings be accessed for Osilodrostat Phosphate?
Yes. CMOs like WuXi AppTec and Novasep provide custom synthesis services catering to specific formulation and purity requirements, suitable for clinical and commercial needs.

---

References

1. [1] Novartis AG. Osilodrostat (LCI699) Data Sheet, 2022.
2. [2] WuXi AppTec Official Website. API Manufacturing Capabilities.
3. [3] Novasep. Custom API Synthesis and Scale-Up Solutions.
4. [4] Hubei Provi Chemical Technology Co., Ltd. Product Portfolio and Certifications.
5. [5] Regulatory Guidelines for API manufacture, ICH Q7.