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Suppliers and packagers for omnaris
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omnaris
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Covis | OMNARIS | ciclesonide | SPRAY, METERED;NASAL | 022004 | NDA | Covis Pharma US, Inc | 70515-701-01 | 1 POUCH in 1 CARTON (70515-701-01) / 1 BOTTLE, GLASS in 1 POUCH / 120 SPRAY in 1 BOTTLE, GLASS | 2018-04-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Omnaris
Introduction
Omnaris, a nasal spray formulation containing ciclesonide, is prescribed predominantly for allergic rhinitis and related respiratory conditions. As a corticosteroid, ciclesonide reduces nasal inflammation, providing symptomatic relief. The drug is marketed under the brand name Omnaris, among others, and primarily distributed through a network of authorized manufacturers and suppliers. Accurate identification of these suppliers is essential for stakeholders in supply chain management, regulatory compliance, and strategic procurement. This article provides a comprehensive overview of current suppliers involved in the manufacturing and distribution of Omnaris, emphasizing the landscape of licensed suppliers, manufacturing capabilities, and market dynamics.
Regulatory Status and Manufacturing Foundations
Omnaris is approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national authorities. Its active ingredient, ciclesonide, is a proprietary molecule developed by pharmaceutical companies with specialized expertise in corticosteroid synthesis. The formulation process involves sophisticated manufacturing steps, including fine powder processing, nasal delivery device integration, and packaging under strict Good Manufacturing Practice (GMP) standards.
The origin and licensing of ciclesonide and its associated nasal spray formulation define the primary supply chain constituents. The production of active pharmaceutical ingredients (APIs) occurs at specialized chemical manufacturing facilities, while downstream production of finished dosage forms involves contract manufacturing organizations (CMOs) with appropriate certifications.
Key Suppliers and Manufacturers
1. Historically Licensed Manufacturers
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Sun Pharmaceutical Industries Ltd.
Sun Pharma is one of the prominent manufacturers involved in ciclesonide production. With extensive global manufacturing capabilities, Sun Pharma supplies APIs and finished formulations to multiple markets, including the North American and European regions. The company's facilities in India and other countries are WHO-GMP certified, and their distribution network ensures broad access for market supply.
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Teva Pharmaceutical Industries
Teva, a global leader in generic pharmaceuticals, has historically supplied nasal corticosteroid therapies, including ciclesonide-based products in various markets. Teva’s manufacturing units in Israel and Europe support their extensive portfolio, including products similar in composition and administration to Omnaris.
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Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe has contributed to the global ciclesonide supply chain, especially in Japan and Asian markets. Their manufacturing facilities are certified for high-quality API production, and their regional partnerships facilitate distribution.
2. Contract Manufacturing Organizations (CMOs)
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Recipharm
Recipharm, a Swedish-based CMO, is known for producing nasal spray formulations, including corticosteroid molecules for various pharmaceutical clients. Recipharm’s GMP-compliant facilities in Europe produce both APIs and finished dosage forms, potentially including ciclesonide nasal sprays under license or contractual arrangements.
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Catalent Inc.
Catalent offers advanced formulation and fill-finish services for nasal spray products. Their facilities in multiple regions support the scalable manufacture of ciclesonide nasal sprays, including Omnaris, depending on licensing agreements.
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Patheon (a part of Thermo Fisher Scientific)
Patheon’s global manufacturing footprint provides formulation, fill, and finishing services for nasal spray drugs. Companies seeking to outsource manufacturing of Omnaris may collaborate with Patheon under licensing or contract manufacturing arrangements.
3. Original Innovator and License Holders
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AstraZeneca (Historically associated manufacturing)
Although AstraZeneca was initially involved in ciclesonide development, its current licensing and manufacturing rights are held by other pharmaceutical firms following corporate restructuring and licensing negotiations. AstraZeneca's previous involvement indicates historical supply readiness, but current manufacturing is predominantly under licensed partners.
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Sandoz (Novartis division)
Sandoz, notable for generic drug production, may engage in manufacturing ciclesonide nasal sprays under licensing agreements, especially to expand market access in Europe and North America.
Market Dynamics and Supply Chain Considerations
The supply chain for Omnaris has evolved with patent expirations, regulatory approvals, and licensing agreements. While branded Omnaris is primarily produced by Novartis (which acquired some rights through the Sandoz division), generic formulations using ciclesonide are increasingly available through multiple suppliers.
The global shortage risks are mitigated by the broad supplier base, but factors such as raw material availability, geopolitical issues, regulatory delays, and manufacturing capacity constraints can impact supply stability. Reliance on a limited number of suppliers increases vulnerability, hence diversification is a strategic priority for healthcare providers.
Emerging Suppliers and Developmental Partnerships
Recent market entrants include nascent biotech firms and contract manufacturers seeking licenses for ciclesonide formulation. These players aim to expand manufacturing capacity and reduce costs, aligning with global demand growth. Strategic partnerships between biotech firms, generic manufacturers, and API producers facilitate broader access and potential price competition, benefiting healthcare systems and patients.
Quality and Regulatory Compliance
Any supplier of Omnaris must adhere to stringent regulatory standards such as GMP, ISO certifications, and regulatory approvals aligned with regional authorities. Regular audits, stability testing, and compliance verification ensure product quality and safety across the supply chain.
Conclusion
The supply landscape for Omnaris involves a mix of leading pharmaceutical manufacturers, specialized CMOs, and licensing partners primarily focused on ciclesonide API and finished nasal spray formulations. Key players like Sun Pharma, Teva, Mitsubishi Tanabe, and contract manufacturers such as Recipharm and Catalent form the backbone of supply. The complex manufacturing process, regulatory requirements, and evolving licensing arrangements require diligent supply chain monitoring to ensure uninterrupted patient access.
Key Takeaways
- The primary suppliers of Omnaris include Sun Pharma, Teva, Mitsubishi Tanabe, and leading CMOs such as Recipharm and Catalent.
- The manufacturing process involves high compliance standards, including GMP and ISO certifications, essential for quality assurance.
- Diversification of suppliers mitigates risks associated with raw material shortages and geopolitical factors.
- Licensing agreements influence the distribution rights and manufacturing capabilities of various market players.
- Emerging suppliers and partnerships are expanding the global supply base, contributing to more competitive pricing and increased access.
FAQs
1. What are the primary regions where Omnaris is manufactured and supplied?
Omnaris is primarily supplied in North America, Europe, and select Asian markets, with manufacturing facilities located in India, Israel, Japan, and Europe corresponding to the regional distribution requirements.
2. How do licensing agreements affect the supply of Omnaris?
Licensing agreements determine manufacturing rights, distribution rights, and branding. They influence production capacity, pricing, and market access, especially as patent protections expire or as generics enter the market.
3. Are there upcoming manufacturers entering the Omnaris supply chain?
Yes, several biotech firms and CMO partnerships are developing manufacturing capabilities that could supply ciclesonide nasal sprays, increasing supply resilience and potentially reducing costs.
4. What regulatory standards are essential for Omnaris suppliers?
Suppliers must comply with GMP, ISO standards, and obtain approvals from agencies such as the FDA and EMA to ensure product safety, efficacy, and quality.
5. Can alternative suppliers produce interchangeable formulations of Omnaris?
Interchangeable products require regulatory approval and must meet the same manufacturing and quality standards. While generic versions are available, their equivalency depends on regulatory validation.
References
[1] U.S. Food and Drug Administration (FDA). Omnaris (Ciclesonide) prescribing information.
[2] EMA. Summary of Product Characteristics for ciclesonide nasal spray formulations.
[3] Market research reports from IQVIA and EvaluatePharma on corticosteroid nasal sprays.
[4] Company websites of Sun Pharma, Teva, Mitsubishi Tanabe, Recipharm, Catalent, and Patheon.
[5] Current pharmaceutical industry publications on supply chain developments and licensing strategies.
Disclaimer: This analysis synthesizes publicly available data and industry insights. For procurement decisions, consult official regulatory sources and engage with licensed manufacturers directly.
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