Suppliers and packagers for generic pharmaceutical drug: OTESECONAZOLE

OTESECONAZOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mycovia Pharms	VIVJOA	oteseconazole	CAPSULE;ORAL	215888	NDA	Mycovia Pharmaceuticals, Inc.	74695-823-18	1 CONTAINER in 1 CARTON (74695-823-18) / 1 BLISTER PACK in 1 CONTAINER / 18 CAPSULE in 1 BLISTER PACK	2022-07-11

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Oteseconazole

Introduction
Oteseconazole, marketed under the trade name VT-1161 among other developmental designations, is an investigational antifungal agent developed primarily by Tetraphase Pharmaceuticals, now part of OrbiMed. It belongs to the tetrazole class of antifungals, designed to inhibit fungal cytochrome P450 enzyme 14α-demethylase, thereby disrupting ergosterol synthesis essential for fungal cell membrane integrity. Oteseconazole exhibits potent activity against Candida species, especially Candida albicans, Candida glabrata, and Candida krusei—pathogens responsible for vulvovaginal candidiasis (VVC), among other fungal infections. As an investigational drug, its primary suppliers are those involved in formulation development, clinical trial material production, and, eventually, commercial manufacturing once approval is secured.

Current Suppliers and Manufacturing Landscape

1. Development and Clinical Supply Contractors
Given that Oteseconazole remains in the clinical development phase (as of the latest available data), active supply partnerships are primarily with Contract Manufacturing Organizations (CMOs). These organizations handle synthesis, formulation, and supply of Investigational New Drug (IND)-phase materials.

• Catalent, Inc.
  Catalent offers comprehensive development and manufacturing services, including small-molecule synthesis and fill-finish capabilities. They have extensive experience in supporting clinical-stage pharmaceuticals, including antifungals similar to oteseconazole. Their facilities in the United States and Europe enable scalable production suitable for clinical trials.

• Thermo Fisher Scientific (Patheon)
  Thermo Fisher’s Patheon division provides CDMO services such as active pharmaceutical ingredient (API) manufacturing and formulation. Their expertise spans small-molecule API synthesis, often supporting antifungal agents in clinical trial phases.

• Lonza
  Lonza is another key CMO specializing in small molecule synthesis and formulation. Their global facilities can undertake the manufacturing of experimental antifungal agents like oteseconazole, ensuring compliance with regulatory standards such as cGMP.

2. API Suppliers
Oteseconazole’s active pharmaceutical ingredient (API) synthesis requires specialized chemical manufacturing, including the procurement of key raw materials and intermediates.

• Contract Suppliers of Intermediates and API:
  Several CMOs in India and China have the capability to produce complex antifungal APIs under strict quality controls. These suppliers are often chosen for their cost efficiency, quality, and capacity to meet clinical trial demands.

  • CSPC Pharmaceutical Group (China): Known for producing a range of APIs, including antifungals and anti-infectives, CSPC has substantial manufacturing capacity and global distribution channels.

  • Hetero Labs (India): Hetero supplies API synthesis services for various antifungal agents, including candidate compounds similar to oteseconazole.

• Raw Material Suppliers
  Some of the chemical raw materials necessary for oteseconazole’s synthesis may be sourced from specialized chemical suppliers such as Sigma-Aldrich, TCI Chemicals, or Alfa Aesar, which provide high-purity reagents conforming to pharmaceutical standards.

3. Commercial-Scale Manufacturing (Post-Approval)
While oteseconazole remains investigational, potential late-stage and commercial suppliers are expected to emerge following regulatory approval (e.g., FDA, EMA).

• Pfizer, GlaxoSmithKline, or Novartis (assumed future players)
  Large pharmaceutical companies with antifungal portfolios could acquire rights or develop their own manufacturing streams for oteseconazole. Their supply chains would include:

  • API production sites: Located globally, particularly in the US, Europe, and Asia.
  • Formulation and Fill-Finish facilities: For oral tablets or other dosage forms, adhering to Good Manufacturing Practice (GMP).

• Specialized Contract Manufacturers
  Smaller, high-quality CMOs such as Recipharm, Aenova, or Boehringer Ingelheim could be contracted for large-scale production once the drug advances toward commercialization.

4. Regulatory and Supply Chain Considerations
To ensure uninterrupted supply, manufacturers often secure multiple sourcing agreements for raw materials and components. Additionally, establishing a diversified supply chain mitigates risks related to geopolitical, logistical, or regulatory disruptions.

Emerging Trends and Future Outlook

• The increasing reliance on regional CMOs, especially in Asia-Pacific, could lower production costs and enhance supply flexibility.
• As the drug progresses through clinical phases, strategic partnerships with global API producers are likely to solidify, ensuring compliance with international standards.
• Post-approval, large pharma involvement becomes essential for widespread distribution, necessitating integration of supply chains across continents.

Conclusion
Suppliers for oteseconazole are predominantly found among contract manufacturing organizations specializing in small-molecule pharmaceuticals. Their roles span from early development through Phase III clinical trials and, ultimately, commercial manufacturing. The landscape is characterized by a mixture of regional API producers, pharmaceutical CMOs, and raw material suppliers aligned to meet rigorous quality and regulatory standards. Building resilient, diversified supply chains remains critical as oteseconazole advances toward market approval, promising an impactful addition to antifungal therapeutics.

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Key Takeaways

• As an investigational product, oteseconazole’s primary suppliers are CMOs handling API synthesis, formulation, and clinical supply.
• Major CMOs supporting early development include Catalent, Thermo Fisher (Patheon), and Lonza, with capabilities spanning API production and fill-finish services.
• Global API suppliers, mainly in India and China, are poised to support scaled manufacturing once clinical and regulatory milestones are achieved.
• Future commercialization will likely involve large pharma companies and specialized CMOs, emphasizing supply chain robustness.
• Diversifying raw material sources and establishing regional manufacturing hubs can mitigate supply risks.

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Frequently Asked Questions (FAQs)

1. When is oteseconazole expected to reach the commercial market?
Oteseconazole remains in clinical development stages, with no definitive date for market approval. Its timeline depends on successful trial outcomes and regulatory review.

2. Which companies are currently involved in producing oteseconazole APIs?
While specific API suppliers are not publicly disclosed, top candidates include Indian and Chinese API manufacturers like Hetero Labs and CSPC, engaged through contractual agreements during development phases.

3. Are there alternative suppliers if one manufacturing source encounters issues?
Yes. Multinational pharmaceutical companies typically establish multiple supply agreements across regions to ensure continuity and mitigate supply chain risks.

4. Will major pharmaceutical firms be involved in the manufacturing of oteseconazole post-approval?
Likely. Once authorized, large pharma entities with antifungal product portfolios will oversee or contract out large-scale manufacturing, ensuring global distribution.

5. How does the supply chain for investigational drugs like oteseconazole differ from commercial drugs?
Investigation-stage supply chains are often more flexible, reliant on contract manufacturers, and involve smaller batch sizes. Commercial supply chains are more complex, requiring scaled-up manufacturing, rigorous quality controls, and complex logistics.

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Sources
[1] ClinicalTrials.gov. "OTSECONAZOLE (VT-1161) Clinical Trials."
[2] Tetraphase Pharmaceuticals. "Pipeline and Development Data."
[3] Contract Manufacturing Organization capabilities: Catalent, Thermo Fisher Scientific, Lonza.
[4] Pharmaceutical raw material suppliers: Sigma-Aldrich, TCI Chemicals, Alfa Aesar.