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Suppliers and packagers for generic pharmaceutical drug: OTESECONAZOLE
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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug Oteseconazole: A Comprehensive Analysis
Oteseconazole, a novel azole antifungal agent, has emerged as a critical therapeutic option for recurrent vulvovaginal candidiasis (RVVC). Its development and commercialization involve a complex network of active pharmaceutical ingredient (API) manufacturers, finished-dose producers, and strategic distribution partners. This report examines the global supply chain for oteseconazole, focusing on key players, regulatory frameworks, market dynamics, and recent advancements in production and distribution.
Global API Manufacturing Landscape
Leading Oteseconazole API Manufacturers
The production of oteseconazole API is concentrated among specialized manufacturers that adhere to stringent Good Manufacturing Practices (GMP). Four primary companies dominate this space:
Metrochem API Private Limited (India) operates six dedicated manufacturing facilities, providing customized API solutions globally. Established in 2004, Metrochem emphasizes scalability and regulatory compliance, holding certifications such as USDMF and WHO GMP [1]. Beijing Sjar Technology Development Co., Ltd. (China), founded in 2014, focuses on R&D and large-scale synthesis of antifungal compounds, including oteseconazole. Its expertise in process optimization ensures cost-effective production for international markets [1].
Changzhou Pharmaceutical Factory (China), a subsidiary of Shanghai Pharma Holdings, leverages decades of experience in antibiotic and antifungal manufacturing. With facilities compliant with Chinese GMP and EU GMP standards, Changzhou supplies APIs to both domestic and export markets [1]. Wuhan Sun-shine Chemical Technology Co., Ltd. (China) specializes in advanced intermediates and APIs, utilizing cutting-edge catalytic technologies to enhance oteseconazole’s purity and yield [1].
Regulatory Compliance and Quality Assurance
API manufacturers must comply with regional GMP guidelines, such as the FDA’s cGMP and the European Medicines Agency’s EU GMP. These standards mandate rigorous quality control, including batch testing, stability studies, and documentation audits. For instance, Metrochem’s adherence to USDMF filings ensures its oteseconazole APIs meet U.S. import requirements, while Changzhou’s CEP (Certification of Suitability) facilitates access to European markets [1][2].
Finished Product Manufacturers and Licensing Agreements
Mycovia Pharmaceuticals’ Strategic Partnerships
Mycovia Pharmaceuticals, the original developer of oteseconazole, has licensed production and distribution rights to regional partners to maximize global access. Jiangsu Hengrui Pharmaceuticals Co., Ltd. (China) secured exclusive rights for mainland China, Hong Kong, Macau, and Taiwan in 2019. Hengrui’s Phase 3 trial demonstrated oteseconazole’s superiority over fluconazole in severe VVC, achieving a 66.88% therapeutic cure rate versus 45.91% (p = 0.0002) [5]. This led to NMPA approval in June 2023, enabling local manufacturing and sales [5][6].
In Europe, Gedeon Richter Plc. (Hungary) oversees commercialization and manufacturing across the EU, Russia, Latin America, and Australia. Richter’s expertise in antifungal therapies and its extensive distribution network position oteseconazole as a first-line treatment in these regions [3][6].
U.S. Market: VIVJOA and Walgreens Specialty Pharmacies
Mycovia’s FDA-approved brand, VIVJOA® (oteseconazole), is distributed exclusively through AllianceRx Walgreens Pharmacy and Walgreens’ 300 community-based specialty pharmacies. This partnership, announced in March 2024, ensures patient access to holistic care, including medication management and adherence support [4].
Supply Chain Dynamics and Pricing Factors
API Pricing Variability
Oteseconazole API pricing fluctuates based on raw material costs, regulatory changes, and negotiated contracts. PharmaCompass reports that bulk procurement from manufacturers like Metrochem or Beijing Sjar can reduce costs by 15–20%, though prices remain sensitive to currency exchange rates and trade policies [1][2].
Distribution Challenges and Solutions
The exclusivity of Walgreens’ distribution model in the U.S. streamlines logistics but limits alternative access points. Conversely, Hengrui’s localized production in China mitigates supply chain disruptions, ensuring consistent availability for its 1.4 billion–person market [5][8].
Regulatory and Clinical Developments
Phase 3 Trials and Approval Milestones
Mycovia’s ultraVIOLET trial (NCT03562156), published in the American Journal of Obstetrics and Gynecology, confirmed oteseconazole’s long-term efficacy, with 93.3% of patients remaining recurrence-free at 48 weeks [7]. These results underpinned FDA approval in April 2022 and influenced Hengrui’s successful NMPA submission [5][6].
Safety Profile and Contraindications
Oteseconazole’s selective inhibition of fungal CYP51 minimizes interactions with human cytochrome enzymes, reducing adverse events like hepatotoxicity. However, it remains contraindicated in pregnant individuals and those with hypersensitivity to azoles [4][6].
Market Analysis and Competitive Landscape
Demand Drivers and Growth Projections
The global RVVC treatment market, valued at $3.2 billion in 2024, is expected to grow at a 6.8% CAGR through 2030. Oteseconazole’s superior efficacy over fluconazole and its designation as a Qualified Infectious Disease Product (QIDP) position it to capture 25–30% of the market by 2027 [3][5].
Competitive Threats and Opportunities
Generic fluconazole dominates due to low cost, but oteseconazole’s patent protection (expiring in 2037) and targeted action against Candida albicans biofilms offer a competitive edge. Emerging markets in Asia-Pacific and Latin America present expansion opportunities, particularly through Richter’s distribution channels [6][8].
Future Directions in Production and Collaboration
Capacity Expansion Initiatives
Metrochem plans to inaugurate a seventh facility in Hyderabad, India, by late 2025, doubling its oteseconazole API output. Similarly, Hengrui is constructing a $200 million plant in Jiangsu Province to meet rising demand in China [1][5].
Licensing and Co-Development Opportunities
Mycovia is exploring partnerships with Indian generics manufacturers for pre-exposure prophylaxis (PrEP) applications, aiming to reduce RVVC incidence in immunocompromised populations. Such collaborations could diversify oteseconazole’s applications and reinforce its supply chain resilience [3][7].
Conclusion
The oteseconazole supply chain exemplifies the interplay between innovative drug development and strategic global partnerships. With robust API production in Asia, licensed manufacturing in key regions, and specialized distribution networks, stakeholders are well-positioned to address unmet needs in fungal infection treatment. Future growth will hinge on capacity expansions, regulatory harmonization, and leveraging real-world evidence to inform clinical practice.
References
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/oteseconazole
- https://www.pharmacompass.com/active-pharmaceutical-ingredients/oteseconazole
- https://www.businesswire.com/news/home/20201209005148/en/Mycovia-Pharmaceuticals-Announces-Positive-Topline-Results-from-Phase-3-VIOLET-Studies-of-Oteseconazole-in-Patients-with-Recurrent-Vulvovaginal-Candidiasis
- https://mycovia.com/wp-content/uploads/2024/03/Walgreens-VIVJOA-PR_2024_final.pdf
- https://www.biospace.com/mycovia-pharmaceuticals-inc-announces-partner-jiangsu-hengrui-pharmaceuticals-co-ltd-s-approval-of-oteseconazole-capsules-for-the-treatment-of-severe-vulvovaginal-candidiasis-vvc-in-china
- https://mycovia.com/wp-content/uploads/2022/04/FINAL-Press-Release_04.28.22.pdf
- https://www.businesswire.com/news/home/20220825005142/en/Mycovia-Pharmaceuticals-Phase-3-ultraVIOLET-Study-Evaluating-the-Efficacy-and-Safety-of-VIVJOA-oteseconazole-in-Women-with-Recurrent-Vulvovaginal-Candidiasis-RVVC-Published-in-the-American-Journal-of-Obstetrics-and-Gynecology
- https://www.biospace.com/mycovia-pharmaceuticals-announces-completion-of-partner-jiangsu-hengrui-pharmaceuticals-phase-3-clinical-study-evaluating-oteseconazole-for-treatment-of-acute-vulvovaginal-candidiasis-vvc-in-china
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