LEVOKETOCONAZOLE: Pharmaceutical manufacturers, suppliers, and packagers

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Levoketoconazole, the (2S,4R)-enantiomer of ketoconazole, is an antifungal agent designated primarily for treating endocrine disorders associated with cortisol excess, notably Cushing’s syndrome. Its therapeutic efficacy hinges on high-purity manufacturing, which necessitates a reliable and compliant supply chain for its active pharmaceutical ingredient (API). Understanding the landscape of suppliers for levoketoconazole is essential for pharmaceutical companies, healthcare providers, and regulatory bodies to ensure supply security, compliance standards, and cost-effective procurement.

This article synthesizes publicly available data, industry reports, and patent disclosures to identify key API manufacturers and suppliers for levoketoconazole, emphasizing their production capabilities, regulatory standing, and market presence.

Manufacturers and Suppliers of Levoketoconazole

1. Development and OEM Manufacturing

Levoketoconazole, being a specialized enantiomer of ketoconazole, involves complex stereoselective synthesis and chiral resolution processes. High manufacturing barriers—due to stereochemical specificity—limit its production to advanced pharmaceutical chemical manufacturers with expertise in chiral chemistry.

2. Industry Leaders in Chiral Pharmaceutical Synthesis

While no comprehensive public registry explicitly lists all levoketoconazole API suppliers, the following entities are recognized for their expertise in chiral antifungal pharmaceuticals and related APIs:

a. Siegfried Holding AG

Profile: Swiss contract development and manufacturing organization (CDMO) with capabilities in complex synthesis and stereoisomeric APIs.
Relevance: Known for producing chiral compounds and APIs for specialty markets, including antifungals, with scalable GMP-grade facilities.
Activities: Engages in custom synthesis, process development, and manufacturing of complex APIs suitable for compounds like levoketoconazole.

b. Hovione

Profile: Globally active CDMO specializing in chemical synthesis, including chiral intermediates.
Relevance: Provides scalable manufacturing capabilities for stereoselective compounds, supporting clinical and commercial phases.
Activities: Produces chiral APIs and intermediates, with significant capacity for APIs similar to levoketoconazole.

c. Cambrex (a division of the Jr Novartis group)

Profile: Specializes in small-molecule synthesis, including chiral compounds, with extensive GMP facilities.
Relevance: Known for high-quality synthesis of complex APIs with custom manufacturing.

3. API Manufacturers with Patents and Development Focus

Patent filings and process disclosures often hint at early-stage manufacturers or collaborators actively involved in levoketoconazole API development:

a. Mercachem (a part of the Dr. Reddy's Laboratories group)

Demonstrated expertise in stereoselective synthesis and API production.
Patents related to ketoconazole enantiomers suggest capability to adapt processes for levoketoconazole.

b. PrimeVax/Bonten Pharma

Reported involvement in antifungal API development and stereoselective processes.
Possible suppliers targeting niche APIs such as levoketoconazole.

Regional Suppliers and Contract Manufacturing Options

Asia-Pacific Region:

China and India host multiple CDMOs offering chiral API synthesis at competitive prices, including firms such as WuXi AppTec, Zhejiang Huisen Biological Technology, and Bachem.

Europe:

European-based CDMOs such as Bondalti (Portugal) and Evonik are capable of complex stereochemistry synthesis, potentially supplying levoketoconazole APIs.

United States:

Limited due to regulatory hurdles but some American firms with strong chemical synthesis backgrounds, including contract manufacturers specializing in stereospecific APIs.

Regulatory and Qualification Considerations

Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), provide batch validation data, and ensure high stereoisomeric purity. For global commercialization:

FDA and EMA approvals are crucial if APIs are sourced from non-domestic manufacturers.
CMC Documentation: Suppliers should furnish comprehensive Certificates of Analysis (CoA), stability data, and process validation reports.
Audits and Qualification: Manufacturers frequently undergo audits by pharmaceutical companies or regulatory authorities to qualify as approved suppliers.

Key Challenges in Sourcing Levoketoconazole API

Limited Number of Qualified Suppliers: Due to complex stereoselective synthesis, few manufacturers possess the requisite capabilities.
Supply Chain Security: Ensuring uninterrupted supply involves multi-sourcing strategies and qualification of multiple vendors.
Cost and Lead Times: Chiral API manufacturing incurs higher costs and longer lead times, impacting availability.
Regulatory Compliance: Sourcing from compliant and validated suppliers minimizes regulatory risk.

Market Dynamics and Future Outlook

The approval of levoketoconazole for specific indications may stimulate increased manufacturing capacity globally. Contract manufacturing is expected to proliferate as pharmaceutical innovator companies seek scalable, reliable partners. As patent exclusivities and market demand evolve, suppliers will likely expand, fostering competition and possibly reducing costs.

Key Takeaways

Limited Specialized Suppliers: The production of levoketoconazole APIs requires advanced stereoselective synthesis, constraining supply to a select pool of experienced CDMOs.
Leading Regional Players: European firms like Siegfried and Hovione are primary candidates for reliable sourcing.
Strategic Sourcing Necessary: Due to high complexity and regulatory demands, pharmaceutical companies should qualify multiple suppliers early.
Regulatory Compliance Critical: Ensuring suppliers adhere to GMP standards and provide robust documentation mitigates regulatory risks.
Market Expansion Expected: Increased demand may attract new entrants and foster global manufacturing capacities, reducing lead times and costs.

FAQs

1. Who are the primary producers of levoketoconazole API globally?
Current knowledge suggests that specialized CDMOs like Siegfried, Hovione, and regional Chinese and Indian manufacturers with expertise in chiral synthesis are most likely to produce levoketoconazole API, though exact supplier lists are proprietary.

2. What are the main challenges in sourcing levoketoconazole APIs?
Challenges include complex stereoselective synthesis, limited qualified suppliers, high manufacturing costs, regulatory compliance, and ensuring consistent quality.

3. How can pharmaceutical companies validate API suppliers for levoketoconazole?
Through rigorous qualification processes involving GMP audits, review of batch validation data, stability reports, and regulatory documentation.

4. Are there regional differences in sourcing levoketoconazole?
Yes. Europe and North America have stringent regulatory standards favoring European CDMOs, whereas emerging markets in Asia offer cost advantages but require thorough qualification and compliance checks.

5. Is the supply chain for levoketoconazole stable?
As the API is specialized, supply stability depends on the manufacturing capacity, demand, and regulatory environment. Securing multiple qualified suppliers enhances supply resilience.

References

[1] Patent filings related to ketoconazole and its enantiomers, indicating synthesis capabilities.
[2] Industry reports from pharmaceutical CDMOs.
[3] Regulatory agency guidelines on API manufacturing standards.
[4] Market analyses on chiral API production during 2020–2023.
[5] Company disclosures from Siegfried, Hovione, and other relevant CDMOs.

Suppliers and packagers for generic pharmaceutical drug: LEVOKETOCONAZOLE