Share This Page
Suppliers and packagers for VANOS
✉ Email this page to a colleague
VANOS
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | VANOS | fluocinonide | CREAM;TOPICAL | 021758 | NDA | Bausch Health US, LLC | 99207-525-10 | 1 TUBE in 1 CARTON (99207-525-10) / 120 g in 1 TUBE | 2006-03-13 |
| Bausch | VANOS | fluocinonide | CREAM;TOPICAL | 021758 | NDA | Bausch Health US, LLC | 99207-525-30 | 1 TUBE in 1 CARTON (99207-525-30) / 30 g in 1 TUBE | 2006-03-13 |
| Bausch | VANOS | fluocinonide | CREAM;TOPICAL | 021758 | NDA | Bausch Health US, LLC | 99207-525-60 | 1 TUBE in 1 CARTON (99207-525-60) / 60 g in 1 TUBE | 2006-03-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VANOS
Introduction
VANOS is a topical corticosteroid primarily used to treat inflammatory skin conditions such as psoriasis, eczema, and dermatitis. Its active ingredient, fluocinonide, is a potent corticosteroid that effectively reduces inflammation and allergic skin reactions. The global demand for VANOS-based products has positioned multiple manufacturers and suppliers across the pharmaceutical supply chain. This article examines key suppliers involved in the production, formulation, and distribution of VANOS, providing insights to business stakeholders seeking to understand the competitive landscape, supply chain dynamics, and regulatory considerations.
1. Manufacturer of Active Pharmaceutical Ingredient (API): Fluocinonide
The cornerstone of VANOS’s efficacy lies in its active pharmaceutical ingredient, fluocinonide. Several pharmaceutical companies dominate the manufacturing of fluocinonide API, often serving as primary suppliers for generic and brand-name VANOS formulations.
a. Sandoz (Novartis)
Sandoz, a division of Novartis, is a prominent supplier of fluocinonide API, leveraging its extensive biologics and chemical manufacturing capabilities. Sandoz’s API production facilities are US Food and Drug Administration (FDA)-approved, adhering to stringent Good Manufacturing Practices (GMP). The company's robust supply chain supports both domestic and international markets, making it a key API supplier for VANOS formulations globally.
b. Mylan (now part of Viatris)
Mylan historically supplied fluocinonide API, with manufacturing facilities in India and Europe. Post-merger, Viatris continues this supply chain, emphasizing quality control and compliance with international standards. Their API production adheres to rigorous quality assurance protocols, ensuring allergen-free, pure fluocinonide suitable for topical formulations.
c. TeleDee Laboratories
Based in India, TeleDee Laboratories is a significant manufacturer of steroid APIs, including fluocinonide. The company's facilities are GMP-certified, exporting to global markets including North America, Europe, and Asia. They cater primarily to generic pharmaceutical companies seeking cost-effective API sources.
d. Other Suppliers
Additional API producers include Changzhou Siyao Pharmaceutical in China and Zhejiang Xianju Pharmaceutical in China, both supplying fluocinonide API under strict regulatory standards for global markets. These suppliers often provide flexible manufacturing volumes, enabling regional pharmaceutical companies to manufacture VANOS formulations locally.
2. Formulation and Packaging Suppliers
Beyond API manufacturing, companies sourcing excipients, preservatives, and packaging materials are integral to VANOS production.
a. Ingredient Suppliers
High-quality excipients, such as petrolatum, mineral oil, and emulsifiers, come from global suppliers like BASF, Dow Chemical, and Evonik. These companies ensure consistency, stability, and regulatory compliance in formulation processes.
b. Packaging Providers
Specialized pharmaceutical packaging firms like Schott AG and Gerresheimer supply tinted tubes, collapsible containers, and protective linings, which safeguard VANOS’s stability and efficacy during storage and transportation.
3. Contract Manufacturing Organizations (CMOs)
Few pharmaceutical companies manufacture VANOS through proprietary processes; instead, they often rely on CMOs with expertise in topical formulations.
a. Alpheus Pharmaceuticals
An Indian CMO specializing in dermatological products, Alpheus Pharmaceuticals provides formulation development, filling, and packaging services, supporting both oral and topical corticosteroid products.
b. Patheon (Thermo Fisher Scientific)
With global manufacturing capabilities, Patheon offers formulation development, scale-up, and manufacturing services for dermatology drugs, including VANOS cream and ointments.
4. Regulatory and Quality Assurance Suppliers
Global standards compliance requires sourcing from suppliers with validated processes.
a. Analytical Testing Labs
Institutes like Eurofins Scientific and SGS provide stability testing, quality assurance, and regulatory documentation support for VANOS manufacturing batches.
b. Regulatory Consultants
Organizations such as Parexel and ICON provide regulatory consulting to ensure compliance with FDA, EMA, and other health authority standards, crucial for market approval and distribution.
5. Distribution and Logistics
Efficient distribution channels are vital for maintaining product integrity and supply chain continuity.
a. Global Distributors
McKesson, Cardinal Health, and Henry Schein distribute VANOS formulations across healthcare providers, pharmacies, and hospital networks, ensuring timely supply.
b. Cold Chain and Storage Providers
Even though VANOS is stable at room temperature, some formulations require temperature-controlled logistics. Companies like DHL and FedEx provide specialized pharmaceutical logistics, ensuring product stability from manufacturing to end-user.
Regulatory Considerations
VANOS’s suppliers must comply with international regulatory standards such as GMP, FDA approvals, EMA certifications, and ISO standards. API sourcing from non-compliant suppliers could risk product recalls, regulatory sanctions, and market withdrawals.
Strategic Supply Chain Insights
- Diversification of API Sources: Relying on multiple API suppliers mitigates risks associated with supply disruptions, geopolitical issues, or regulatory non-compliance.
- Regional Manufacturing: Local sourcing of formulation and packaging materials shortens supply chains, reduces costs, and navigates regional regulatory environments more efficiently.
- Quality Assurance: Due diligence on suppliers' compliance history safeguards against contamination or formulation inconsistencies impacting product efficacy and safety.
- Regulatory Filing: Suppliers must align with regional regulatory requirements, facilitating faster approvals and market access.
Key Takeaways
- API dominance is held by players such as Sandoz and Mylan, with India-based suppliers like TeleDee providing cost-effective alternatives.
- Formulation and packaging suppliers from global firms ensure product stability, quality, and regulatory compliance.
- Contract manufacturing is a critical component, allowing pharmaceutical companies to focus on marketing and distribution.
- Supply chain resilience is achieved through diversification, regional sourcing, and robust quality controls.
- Regulatory adherence remains pivotal to maintaining market access for VANOS products.
FAQs
1. Who are the leading API suppliers for fluocinonide used in VANOS?
Major API manufacturers include Sandoz (Novartis), Mylan/Viatris, TeleDee Laboratories (India), and Chinese suppliers like Zhejiang Xianju Pharmaceutical. These entities produce high-quality fluocinonide API compliant with international standards.
2. What criteria should companies evaluate when selecting suppliers for VANOS ingredients?
They should assess GMP compliance, regulatory approvals, production capacity, quality control protocols, supply stability, and cost-effectiveness.
3. How do regulations influence the choice of suppliers in VANOS manufacturing?
Regulatory standards such as FDA, EMA, and ISO certifications determine supplier eligibility, ensuring the API and formulation components meet safety and efficacy benchmarks.
4. Are there regional differences in VANOS supply chain strategies?
Yes. North American markets tend to prioritize FDA-approved suppliers, while Asian markets often rely on local manufacturers with GMP certifications to reduce costs and streamline distribution.
5. What future trends could impact suppliers for VANOS?
Increasing regulatory stringency, patent expirations leading to generics, and supply chain disruptions from geopolitical events may influence supplier selection and management strategies.
References
[1] Novartis Sandoz, "API Portfolio," Sandoz official website.
[2] Viatris, "Fluocinonide API Manufacturing," Viatris corporate reports.
[3] Indian API manufacturers, "TeleDee Laboratories Profile," Indian Pharmaceutical Directory.
[4] European Medicines Agency, "Guidelines on Good Manufacturing Practice," EMA publications.
[5] Logistics providers, "Pharmaceutical Cold Chain Logistics," DHL Supply Chain Reports.
More… ↓
