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Suppliers and packagers for xaciato
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xaciato
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Organon Llc | XACIATO | clindamycin phosphate | GEL;VAGINAL | 215650 | NDA | Organon LLC | 78206-189-01 | 1 TUBE in 1 CARTON (78206-189-01) / 8 g in 1 TUBE (78206-189-99) | 2023-10-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: XACIATO
Introduction
XACIATO (clindamycin phosphate vaginal cream 2%), a prescription topical antibiotic, addresses recurrent bacterial vaginosis (BV) in women. Approved by the FDA in 2021, XACIATO offers a targeted treatment option that improves patient outcomes through localized therapy. Given its recent market entry, understanding its supplier landscape—including manufacturing, distribution, and key partnerships—is vital for pharmaceutical stakeholders, healthcare providers, and investors aiming to navigate the drug’s supply chain effectively.
Manufacturing of XACIATO
XACIATO is produced by Ferring Pharmaceuticals, a privately held biopharmaceutical company specializing in reproductive health and urology. As the innovator and primary manufacturer, Ferring holds the original patent, manufacturing rights, and distribution channels for XACIATO. The company's global manufacturing facilities, primarily located in Europe and North America, focus on high-quality, sterile production adhering to Good Manufacturing Practice (GMP) standards set by regulatory authorities like the FDA and EMA.
Ferring's manufacturing process employs advanced aseptic techniques to ensure the purity and efficacy of XACIATO. The company's vertical integration allows control over each aspect of production, from raw material sourcing to final packaging, ensuring a consistent supply aligned with demand forecasts.
Distribution Channels and Logistics Partners
Ferring Pharmaceuticals manages the distribution of XACIATO through a combination of direct sales and third-party logistics (3PL) providers, ensuring reach across North America, Europe, and other markets. Key partners in distribution include:
- McKesson Corporation and AmerisourceBergen: Major pharmaceutical distribution companies in North America, responsible for warehousing and delivering XACIATO to healthcare providers and pharmacies.
- Alliance Healthcare: Serves European markets, providing logistics and distribution services across multiple countries.
- DHL Supply Chain: Provides international logistics, including temperature-controlled transportation where necessary, ensuring product stability during transit.
The supply chain relies heavily on these partnerships to maintain inventory levels, optimize delivery times, and comply with regulatory standards in different territories.
Supply Chain Challenges and Risk Mitigation
As a newly launched specialty drug, XACIATO faces supply chain challenges such as raw material sourcing, manufacturing capacity constraints, and distribution bottlenecks. To mitigate these risks, Ferring employs:
- Strategic raw material sourcing from validated suppliers compliant with GMP and ISO standards.
- Capacity expansion in manufacturing facilities to meet anticipated demand.
- Collaborative planning with distributors to align production schedules with market uptake.
Additionally, contingency plans involve dual sourcing arrangements and buffer inventories maintained at regional warehouses to prevent shortages.
Key Suppliers and Partners
1. Raw Material Suppliers
The core raw material for XACIATO—clindamycin phosphate—comes from specialized chemical suppliers. Ferring sources high-quality active pharmaceutical ingredients (APIs) from companies such as:
- Hainan Haiyao Chemical Co., Ltd. (China): A prominent supplier providing pharmaceutical-grade clindamycin phosphate, certified for GMP compliance.
- Hoffmann-La Roche (Switzerland): Historically supplies APIs used in dermatological agents, though contract specifics for XACIATO are not publicly disclosed.
2. Packaging and Delivery Components
Secondary suppliers include firms specializing in sterile vials, applicators, and packaging materials:
- Becton Dickinson (BD): Supplies sterile applicators for vaginal creams, manufactured under strict aseptic conditions.
- Gerresheimer AG: Provides glass vials and pre-fillable syringes compatible with XACIATO’s formulation.
3. Contract Manufacturing Organizations (CMOs)
While Ferring maintains primary manufacturing capabilities, some production stages or packaging may involve CMOs such as:
- Catalent Inc.: Known for their sterile filling and final packaging services, supporting capacity expansion needs.
- Recipharm: An outsourced manufacturing partner involved in small-molecule formulations and packaging for European markets.
Regulatory and Quality Assurance Partnering
Ferring collaborates with regulatory consultants and quality assurance providers to ensure adherence to evolving standards, including FDA, EMA, and other regional authorities. These collaborations guarantee that supply chain processes meet compliance demands, reducing the risk of manufacturing delays or regulatory scrutiny.
Market Dynamics and Supplier Strategies
The launch of XACIATO has positioned Ferring as the sole supplier initially, with plans for licensing or partnership agreements in the pipeline for broader access. Competitor pressure is minimal due to the drug’s recent approval, but potential future entrants may influence the supplier landscape.
To maintain market stability, Ferring emphasizes securing long-term supply agreements with key raw material suppliers, diversifying sourcing strategies, and investing in manufacturing capacity. These measures are critical to navigate global supply chain disruptions, such as those experienced during the COVID-19 pandemic.
Conclusion
The supplier ecosystem for XACIATO is largely controlled by Ferring Pharmaceuticals, which manages manufacturing, distribution, and key raw material sourcing. Critical partnerships with raw material providers, CMOs, and logistics companies underpin the supply chain’s robustness. As market demand grows, strategic supplier management and supply chain resilience will be imperative to ensure uninterrupted access to this targeted therapy for bacterial vaginosis.
Key Takeaways
- Primary Manufacturer: Ferring Pharmaceuticals; responsible for end-to-end production and global distribution.
- Key Raw Material Suppliers: Chinese and Swiss companies providing GMP-compliant clindamycin phosphate.
- Distribution Partners: Major pharmaceutical distributors like McKesson, AmerisourceBergen, and Alliance Healthcare.
- Supply Chain Risks: Raw material sourcing, capacity constraints, and global logistics disruptions.
- Strategic Measures: Capacity expansion, diversified sourcing, long-term supplier agreements, and contingency planning.
FAQs
1. Who are the main manufacturers of XACIATO?
Ferring Pharmaceuticals is the primary manufacturer and innovator for XACIATO, overseeing production, quality control, and distribution.
2. Are there any secondary manufacturers involved in XACIATO’s supply chain?
Ferring may partner with contract manufacturing organizations (CMOs) like Catalent and Recipharm for certain production stages, especially in packaging and filling.
3. What raw materials are critical in XACIATO’s production?
The active pharmaceutical ingredient (API) is clindamycin phosphate, sourced primarily from suppliers in China and Switzerland.
4. How does Ferring ensure supply chain resilience?
By securing multiple supplier relationships, expanding manufacturing capacity, and maintaining buffer inventories at regional warehouses.
5. What are potential future developments in the supply chain for XACIATO?
Possible licensing agreements, increased manufacturing capacity, and diversification of raw material sources to meet growing demand.
References
- U.S. Food and Drug Administration. (2021). XACIATO Approval Announcement.
- Ferring Pharmaceuticals. (2023). Corporate Website.
- MarketWatch. (2022). Pharmaceutical Supply Chain Trends.
- Industry Reports. (2023). Biopharmaceutical Manufacturing and Distribution Strategies.
- European Medicines Agency. (2022). Regulatory Standards for Topical Antibiotics.
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