Suppliers and packagers for recorlev

recorlev

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133	NDA	Xeris Pharmaceuticals, Inc.	72065-003-01	50 TABLET in 1 BOTTLE (72065-003-01)	2021-12-30

Suppliers for the Pharmaceutical Drug: RECORLEV

Last updated: July 30, 2025

Introduction

RECORLEV (levoketoconazole) is a novel oral medication developed primarily for the treatment of endogenous Cushing's syndrome, a serious condition characterized by prolonged exposure to elevated cortisol levels. As a critical therapeutic agent, RECORLEV’s supply chain is central to ensuring its availability for patients worldwide. This article examines the key suppliers involved in its manufacturing process, highlighting their roles, strategic importance, and the implications for stakeholders in the pharmaceutical supply chain.

Overview of RECORLEV’s Manufacturing and Supply Chain

RECORLEV is a synthetic steroidal compound synthesized through a complex chemical process involving multiple intermediates and active pharmaceutical ingredients (APIs). The manufacturing process demands high-quality raw materials, advanced chemical synthesis capabilities, strict regulatory compliance, and scalable production infrastructure. The supply chain can be delineated into several core components:

• Active Pharmaceutical Ingredient (API) Production
• Formulation and Finished Product Manufacturing
• Packaging and Distribution

This structure relies on an extensive network of suppliers, including raw material providers, API manufacturers, formulation facilities, and logistics services.

Key Suppliers of Active Pharmaceutical Ingredients

1. Raw Material Suppliers

The synthesis of levoketoconazole necessitates specialized chemical precursors, often sourced from chemical intermediates suppliers worldwide. These raw material suppliers must meet stringent quality standards such as cGMP (current Good Manufacturing Practices) to ensure consistency and safety.

• Major chemical suppliers: Companies like BASF, Evonik, and Sigma-Aldrich provide specialized raw chemicals and intermediates vital to the synthesis of levoketoconazole.
• Sourcing considerations: Dependence on geographically diverse suppliers introduces risks associated with geopolitical stability, supply disruptions, and tariff changes.

2. API Manufacturers

The core of RECORLEV’s supply chain involves suppliers that produce the active pharmaceutical ingredient—levoketoconazole itself.

• Contract Manufacturing Organizations (CMOs): Several biotech firms and CDMOs specialize in sterile fermentation, complex chemical synthesis, and purification processes required for high-potency APIs.

• Notable API suppliers: While specific names are often proprietary due to confidentiality, some leading global API manufacturers with capabilities in steroid synthesis include:

  • Hovione: Known for sterile and non-sterile API manufacturing.
  • Shilpa Medicare Ltd.: An Indian-based API producer with steroid synthesis expertise.
  • Dr. Reddy’s Laboratories: A major supplier of complex APIs, including steroids.

Implication for stakeholders: The reliance on a limited number of API suppliers underscores the importance of supply chain resilience, particularly amid global disruptions like pandemics or geopolitical tensions.

3. Quality Assurance and Regulatory Compliance

Suppliers must comply with rigorous standards enforced by regulatory agencies like the FDA and EMA. This includes detailed documentation, batch testing, stability analyses, and adherence to international pharmacopoeias. Any deviation can lead to delays, reformulation, or supply cessation.

Formulation and Finished Product Manufacturing

Once the API is produced, it proceeds to formulation plants, where it is combined with excipients and processed into the final dosage form—oral tablets.

• Manufacturers of RECORLEV: The primary manufacturer is Strongbridge Biopharma, involved in final formulation, fill/finish, and packaging.
• Third-party contractors: In some cases, contract manufacturers (CMOs) specializing in oral solid dose forms handle large-scale production to meet global demand.

Packaging and Distribution

Effective distribution depends on logistics companies adhering to cold chain requirements and regulatory standards for pharmaceutical transportation.

• Packaging suppliers: Manufacturers of blister packs, bottles, and labels with appropriate tamper-evident and child-resistant features.
• Distribution partners: Global logistics providers such as DHL, FedEx, and pharmaceutical-specific carriers ensure timely and compliant delivery to markets.

Strategic Considerations for RECORLEV’s Supply Chain

Supply Security and Risk Mitigation

Given the complexity and criticality of RECORLEV, maintaining diversified sourcing pathways is essential. Relying heavily on a single API manufacturer or raw material supplier poses risks of supply interruption, which can delay treatment availability.

Regulatory Challenges

Suppliers must continuously demonstrate compliance with evolving international standards. Any non-compliance can trigger regulatory actions, affecting supply continuity.

Capacity Expansion and Scalability

With increasing demand for RECORLEV, especially following expanded indications or geographic expansions, suppliers addressing capacity limitations are key. Strategic partnerships and early capacity planning are necessary.

Emerging Trends and Future Outlook

Vertical Integration

Some pharmaceutical companies are pursuing vertical integration, sourcing raw materials, manufacturing APIs, and final products internally to assure supply and control costs.

Supply Chain Digitization

Implementation of digital tools enhances traceability, quality monitoring, and predictive analytics, reducing risk and improving responsiveness.

Geographic Diversification

Expanding supplier base across different regions (e.g., India, China, Europe) minimizes geopolitical risks and ensures supply stability.

Conclusion

The supply chain for RECORLEV encompasses a network of specialized suppliers specializing in raw materials, active pharmaceutical ingredients, formulation, and distribution. Ensuring robustness and resilience across these tiers is critical to meet global demand, maintain regulatory compliance, and mitigate risks associated with supply disruptions. Strategic partnerships, regulatory diligence, and supply chain diversification are fundamental to supporting RECORLEV’s role as a vital treatment for Cushing's syndrome.

---

Key Takeaways

• RECORLEV’s supply chain hinges on high-quality raw material providers and specialized API manufacturers with expertise in steroid synthesis.

• Reliability depends on diversified sourcing, strict regulatory adherence, and scalable manufacturing capacity.

• Global geopolitical and logistical factors pose risks; proactive mitigation strategies include regional sourcing and digital supply chain management.

• Strengthening collaborative relationships with suppliers and expanding capacity are essential as demand grows.

• Regulatory compliance and quality assurance are non-negotiable pillars underpinning supply stability.

---

FAQs

1. Who are the primary API suppliers for RECORLEV?
While specific supplier identities often remain confidential, key global players in steroid API manufacturing, such as Shilpa Medicare and Dr. Reddy’s Laboratories, are likely involved.

2. How does supply chain complexity affect RECORLEV availability?
The intricate synthesis process and regulatory requirements mean supply disruptions at any stage—raw materials, API manufacturing, or formulation—can impact drug availability.

3. What risks threaten RECORLEV’s supply chain?
Geopolitical tensions, raw material shortages, manufacturing capacity constraints, and regulatory non-compliance pose significant risks.

4. Are there plans to diversify RECORLEV’s suppliers?
Yes; strategic diversification enhances resilience, especially amid current global supply chain challenges.

5. How can stakeholders ensure continuity of RECORLEV supply?
Investing in supplier relationships, monitoring risk factors, expanding capacity, and leveraging digital tools are key strategies for supply continuity.

---

References

[1] Corporate disclosures and clinical development summaries from Strongbridge Biopharma.
[2] Industry reports on steroid API manufacturing and global supply chain dynamics.
[3] Regulatory documentation and guidance from the FDA and EMA.