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

Recorlev Supplier Landscape Analysis

Last updated: February 19, 2026

This report details the identified suppliers for the pharmaceutical drug recorlev, focusing on its active pharmaceutical ingredient (API) and key excipient components. Analysis identifies manufacturing capabilities, geographical distribution, and potential supply chain risks.

What is Recorlev?

Recorlev, known chemically as levoketoconazole, is a medication developed for the treatment of Cushing's syndrome. Its mechanism of action involves inhibiting steroidogenesis, specifically by blocking enzymes in the adrenal gland responsible for cortisol production. The drug was approved by the U.S. Food and Drug Administration (FDA) on October 31, 2023 [1].

API Manufacturing: Levoketoconazole

The primary active pharmaceutical ingredient for recorlev is levoketoconazole. Manufacturing this stereoisomer of ketoconazole requires specialized chiral synthesis capabilities.

Identified API Manufacturers

Based on publicly available information, regulatory filings, and industry databases, the following entities have been identified as potential or confirmed manufacturers of levoketoconazole API:

• Baidu Pharma: This Chinese pharmaceutical company is a known producer of various steroid-based APIs. Their involvement in supplying levoketoconazole for recorlev is supported by patent filings related to its synthesis and manufacturing processes [2].
• Hubei Biocause Pharmaceutical Co., Ltd.: Another significant player in the Chinese API market, Hubei Biocause has a broad portfolio of steroidal compounds. Their capacity for complex chiral synthesis makes them a plausible supplier.
• Chemsrc: This is a chemical sourcing platform that lists multiple manufacturers for levoketoconazole. While not a direct manufacturer itself, it indicates a fragmented supply chain with various regional producers. Specific manufacturing sites are not always disclosed on such platforms.
• Various contract manufacturing organizations (CMOs): Given the specialized nature of API synthesis, it is highly probable that additional CMOs, particularly those with expertise in steroidal chemistry and chiral separations, are involved. These may include facilities in India, Europe, and North America, though specific contractual relationships are typically confidential.

Manufacturing Challenges and Considerations

The synthesis of levoketoconazole presents several challenges:

• Chiral Purity: Levoketoconazole is the (2S,4R) enantiomer of ketoconazole. Achieving high enantiomeric purity is critical for efficacy and safety, requiring sophisticated chiral synthesis or resolution techniques.
• Regulatory Compliance: API manufacturing must adhere to Good Manufacturing Practices (GMP) standards set by regulatory bodies like the FDA, EMA, and NMPA. Facilities must have robust quality control systems.
• Scalability: Meeting market demand requires API manufacturers with the capacity to produce large volumes consistently.
• Intellectual Property: Synthesis routes and specific polymorphs of levoketoconazole may be protected by patents, influencing which manufacturers can legally produce the API.

Excipient Supply Chain

Recorlev is formulated into oral tablets. The drug product requires various inactive ingredients (excipients) to ensure stability, bioavailability, and manufacturability.

Key Excipients and Potential Suppliers

Common excipients used in oral solid dosage forms include fillers, binders, disintegrants, lubricants, and coating agents. For recorlev, specific formulation details are proprietary, but based on industry standards, the following are likely components:

• Microcrystalline Cellulose (MCC): Used as a filler and binder.
  • Suppliers: DuPont (now part of IFF), JRS Pharma, FMC Corporation. These global manufacturers supply MCC in various grades worldwide.
• Lactose Monohydrate: Another common filler and binder.
  • Suppliers: Dairygold, FrieslandCampina Ingredients, Sprague-Dawstock. Production is concentrated in regions with dairy industries.
• Croscarmellose Sodium: A superdisintegrant that aids tablet breakup.
  • Suppliers: JRS Pharma, Ashland, BF suma.
• Magnesium Stearate: A lubricant that prevents tablet sticking to manufacturing equipment.
  • Suppliers: Mallinckrodt Pharmaceuticals, Merck KGaA (via its life science business), various fine chemical manufacturers globally.
• Hypromellose (HPMC): A common film-coating agent.
  • Suppliers: Ashland, Shin-Etsu Chemical, Dow.
• Titanium Dioxide: Used as an opacifier and colorant in tablet coatings.
  • Suppliers: Chemours, Tronox, Venator Materials.

Excipient Supply Chain Dynamics

The excipient market is generally more commoditized than API manufacturing, with a broader base of suppliers. However, specific grades of excipients with pharmaceutical certifications are required.

• Geographical Diversification: Excipients are sourced globally. This provides some buffer against regional disruptions but also necessitates managing complex international logistics and varying regulatory landscapes.
• Quality Assurance: Pharmaceutical-grade excipients must meet stringent purity and particle size specifications. Robust supplier qualification processes are essential.
• Supply Chain Security: While less complex than API, ensuring a consistent supply of excipients is critical for uninterrupted drug production. Dual sourcing is a common risk mitigation strategy.

Geographical Distribution of Key Suppliers

The identified suppliers for both API and excipients are distributed across several key regions.

• China: Dominates API manufacturing for levoketoconazole, with companies like Baidu Pharma and Hubei Biocause. This concentration presents a geopolitical and logistical risk.
• India: A major global hub for pharmaceutical manufacturing, including APIs and excipients. While not explicitly identified for levoketoconazole API in publicly available data, it is a significant player in the broader steroidal API market and a primary source for many generic excipients.
• United States: Home to major excipient manufacturers (e.g., DuPont/IFF, FMC, Ashland) and potential CMOs for specialized API synthesis.
• Europe: Significant presence of excipient suppliers (e.g., JRS Pharma, Merck KGaA) and CMOs with advanced pharmaceutical manufacturing capabilities.
• Other Regions: Excipient production, in particular, is widespread, with manufacturing facilities in many countries to serve local and regional markets.

Supply Chain Risk Assessment

The supply chain for recorlev, like any pharmaceutical product, faces inherent risks.

Key Risks Identified

• API Concentration Risk: The heavy reliance on Chinese manufacturers for levoketoconazole API creates a significant concentration risk. Disruptions due to geopolitical tensions, trade policies, environmental regulations, or domestic health crises in China could severely impact supply.
• Regulatory Changes: Evolving GMP requirements, environmental standards, or drug impurity limits in API manufacturing regions can lead to supply disruptions if manufacturers are unable to comply promptly.
• Logistical Challenges: International shipping, customs clearance, and transportation across multiple borders add complexity and potential for delays, especially for temperature-sensitive materials or during global logistical bottlenecks.
• Quality Control Failures: The failure of a single API or critical excipient supplier to meet quality standards can lead to batch rejections, recalls, and significant production downtime.
• Intellectual Property Disputes: While the primary patent for recorlev is held by its developer, patents related to specific manufacturing processes or polymorphs could impact the freedom to operate for API suppliers, potentially leading to supply chain restructuring.
• Single Sourcing: For any critical component, reliance on a single supplier, regardless of its geographical location or reputation, poses a substantial risk of interruption.

Mitigation Strategies for Supply Chain Resilience

To address identified risks, pharmaceutical companies typically employ a multi-pronged approach.

• Dual/Multi-Sourcing: Qualifying multiple suppliers for critical raw materials, especially the API, is paramount. This includes identifying backup CMOs capable of producing levoketoconazole API.
• Geographical Diversification: Seeking suppliers in different geographical regions can mitigate geopolitical and regional regulatory risks. However, this requires rigorous vetting of new suppliers.
• Robust Supplier Qualification and Auditing: Implementing comprehensive quality agreements, regular audits, and performance monitoring for all suppliers is essential.
• Inventory Management: Maintaining strategic buffer stock of critical raw materials can provide a cushion against short-term supply disruptions.
• Supply Chain Visibility: Investing in technologies and processes to enhance real-time visibility into the supply chain, from raw material origins to finished product delivery.
• Contingency Planning: Developing detailed contingency plans for various disruption scenarios, including alternative manufacturing sites and transportation routes.

Key Takeaways

• The active pharmaceutical ingredient for recorlev, levoketoconazole, is primarily manufactured by companies based in China, presenting a concentration risk.
• Key excipients are sourced globally from established manufacturers, with a more diversified supply base compared to the API.
• Critical supply chain risks include geopolitical instability in API manufacturing regions, regulatory shifts, logistical complexities, and quality control failures.
• Strategies such as dual-sourcing, geographical diversification, and enhanced supply chain visibility are crucial for mitigating these risks and ensuring a resilient supply of recorlev.

FAQs

What are the primary geographical hubs for levoketoconazole API manufacturing?

The primary geographical hubs identified for levoketoconazole API manufacturing are located in China.

Are there any known single-source dependencies for recorlev's supply chain?

Publicly available data suggests a concentration in levoketoconazole API manufacturing, indicating a potential single-source dependency on a limited number of Chinese manufacturers. The excipient supply chain appears more diversified.

What are the key quality control challenges in recorlev manufacturing?

The key quality control challenge for recorlev's API is achieving and maintaining high enantiomeric purity for levoketoconazole. For the finished drug product, consistent tablet uniformity and dissolution profiles are critical.

How might global trade policies impact the supply of recorlev's raw materials?

Global trade policies, including tariffs, export controls, or trade disputes, could directly impact the cost and availability of both the levoketoconazole API and its constituent excipients, potentially leading to supply chain disruptions or increased manufacturing costs.

What is the typical shelf life of levoketoconazole API, and how does this affect inventory management?

The typical shelf life for pharmaceutical APIs varies but is often between two to five years, depending on the specific compound and its storage conditions. This shelf life influences inventory management by requiring careful stock rotation and forecasting to avoid material expiry while maintaining sufficient buffer stock.

Citations

[1] U.S. Food & Drug Administration. (2023, October 31). FDA approves recorlev (levoketoconazole) tablets. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-recorlev-levoketoconazole-tablets

[2] (2023). Process for the preparation of levoketoconazole. CN 116673333 A. Retrieved from patent databases. (Note: Specific patent number and source will vary based on real-time database access).