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Suppliers and packagers for DYMISTA
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DYMISTA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236 | NDA | Viatris Specialty LLC | 0037-0245-23 | 1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | 2016-10-01 |
| Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-3458-23 | 1 BOTTLE in 1 BOX (0378-3458-23) / 120 SPRAY, METERED in 1 BOTTLE | 2020-04-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DYMISTA
Introduction
DYMISTA is a prescription nasal spray used for the treatment of allergic rhinitis, combining two active ingredients: azelastine hydrochloride and fluticasone propionate. It is marketed under the brand DYMISTA by Mylan (now part of Viatris) and other pharmaceutical companies. The manufacturing and distribution of DYMISTA involve a complex supply chain with multiple key suppliers providing active pharmaceutical ingredients (APIs), excipients, packaging materials, and specialized manufacturing services. Understanding the supplier landscape for DYMISTA is crucial for stakeholders involved in procurement, supply chain logistics, and market analysis.
Active Pharmaceutical Ingredient (API) Suppliers
1. Azelastine Hydrochloride
Azelastine hydrochloride, an antihistamine component of DYMISTA, is sourced globally from a handful of specialized API manufacturers.
- Major Suppliers:
- Shaanxi Top Pharm Chemical Co., Ltd. (China) – A prominent supplier, known for bulk manufacturing and export of azelastine APIs.
- Cipla Limited (India) – Engaged in API production, with a focus on high-quality standards compliant with regulatory requirements.
- Hubei Biocause Pharmaceutical Co., Ltd. (China) – Provides APIs to multiple pharmaceutical firms worldwide.
- Others: Smaller API manufacturers in India and China that supply to generic and brand-name pharmaceutical companies.
2. Fluticasone Propionate
Fluticasone propionate is a synthetic corticosteroid with critical anti-inflammatory properties in DYMISTA.
- Major Suppliers:
- GlaxoSmithKline (GSK): As the original innovator, GSK is a primary supplier of high-quality fluticasone propionate, especially in proprietary formulations.
- China-based Manufacturers: Companies like Shandong Xinhua Pharmaceutical Co., Ltd. and Zhejiang Hisun Pharmaceutical Co., Ltd., produce fluticasone APIs for both domestic and export markets.
- Other API Manufacturers: Several Indian firms, including Sun Pharmaceutical Industries Ltd. and Torrent Pharmaceuticals, supply fluticasone API to generic drug manufacturers.
Regulatory and Quality Considerations
All API suppliers must adhere to Good Manufacturing Practices (GMP) and undergo rigorous quality assessments to meet regulatory standards such as FDA, EMA, and PMDA approvals. The API quality and sourcing significantly influence the safety, efficacy, and regulatory approval process of DYMISTA in various markets.
Excipient and Packaging Material Suppliers
Excipients
While DYMISTA’s primary components are APIs, excipients such as propellants, surfactants, stabilizers, and preservatives are essential for spray formulation.
- Common Suppliers:
- BASF SE (Germany) – Supplies stabilizers and excipients.
- Dow Chemical Company (USA) – Provides surfactants and solvents.
- Loba Chemie (India) – Offers range of pharmaceutical excipients.
Packaging Materials
- Component Suppliers:
- Nestlé Purina or other specialized pharmaceutical packaging firms provide nasal spray bottles, actuators, and caps.
- Aluman (India), Coster Tech (USA), and other firms supply high-quality, sterile, and compliant packaging components to prevent contamination and ensure product stability.
Contract Manufacturers and Fill-Finish Service Providers
Manufacturing DYMISTA involves contract manufacturing organizations (CMOs) specializing in sterile and nasal spray formulations.
- Key CMOs:
- Recipharm AB (Sweden) – Known for sterile production and nasal spray fill-finish capabilities.
- Famar Health Care Services (Greece) – Provides comprehensive nasal spray manufacturing.
- Catalent Inc. (USA) – Offers contract manufacturing, including nasal spray formulations and fill-finish services.
CMOs are crucial for scaling production, ensuring regulatory compliance, and maintaining consistent quality standards for DYMISTA.
Distribution and Logistics
Post-manufacture, DYMISTA’s distribution involves regional and global logistics firms:
- Major Distributors:
- McKesson Corporation (USA) – Distributes to the U.S. healthcare market.
- Almac Group (UK) – Handles logistics across Europe.
- Viatris Logistics Division – Manages global distribution, leveraging extensive supply chain networks.
Efficient distribution ensures steady supply to pharmacies, hospitals, and healthcare providers across diverse markets.
Market and Supply Chain Dynamics
The supply chain for DYMISTA is subject to market fluctuations, geopolitical factors, and regulatory changes. The rising demand for allergy medications, especially in emerging markets, has intensified competition among suppliers. Supply disruptions in China or India, key manufacturing hubs for APIs and excipients, can impact global availability.
Viatris, formerly Mylan's manufacturing division, maintains multiple sources for APIs to prevent shortages. However, dependence on regional suppliers necessitates ongoing risk management strategies, including dual sourcing and inventory buffering.
Regulatory Considerations
Suppliers must comply with evolving regulatory standards to ensure uninterrupted approval and market access:
- FDA and EMA inspections – Regular audits of API and excipient manufacturing facilities.
- GMP compliance – Critical for API quality and product safety.
- Environmental and sustainability regulations – Increasingly influence sourcing and manufacturing practices, especially in China and India.
Conclusion
The supply landscape for DYMISTA encompasses a global network of API producers, excipient suppliers, contract manufacturers, and logistics providers. Dominant API suppliers include Chinese firms like Shaanxi Top Pharm for azelastine and multinational companies such as GSK for fluticasone. Excipients and packaging components are sourced from established chemical and packaging suppliers in Europe, India, and the US. CMOs in Europe and the US provide critical fill-finish services, ensuring adherence to strict regulatory standards.
Maintaining a diversified, resilient supply chain is essential for continuous availability, regulatory compliance, and meeting global demand. Strategic sourcing, rigorous quality control, and proactive risk management underpin the effective supply of DYMISTA.
Key Takeaways
- Global sourcing is vital for API procurement, with key suppliers in China, India, and Europe.
- Regulatory compliance is a critical factor influencing supplier selection and supply chain stability.
- Contract manufacturing organizations play a pivotal role in supply, especially for sterile nasal spray formulations.
- Supply chain resilience requires diversification and proactive risk mitigation strategies.
- Regulatory changes and geopolitical factors are influential risks that manufacturers must monitor continuously.
FAQs
1. Who are the primary API suppliers for DYMISTA?
Major API suppliers include Shaanxi Top Pharm for azelastine hydrochloride and GSK or Chinese manufacturers like Shandong Xinhua Pharmaceutical for fluticasone propionate.
2. Are there alternative suppliers for DYMISTA’s API components?
Yes, multiple suppliers in India and China provide APIs, allowing companies to diversify sourcing and reduce supply risks.
3. How does regulatory compliance affect supplier choices?
Suppliers must meet GMP standards mandated by health authorities such as the FDA and EMA. Non-compliance can lead to supply disruptions, regulatory rejection, or product recalls.
4. What role do contract manufacturers play in DYMISTA supply?
They are responsible for formulation, sterile manufacturing, and fill-finish processes, ensuring product quality, scale, and regulatory adherence.
5. How are supply chain disruptions mitigated for DYMISTA?
Companies adopt dual sourcing, maintain safety stock, and develop flexible logistics arrangements to manage risks associated with geopolitical or environmental disruptions.
Sources:
[1] U.S. Food and Drug Administration (FDA). "Active Pharmaceutical Ingredient (API) Manufacturing Standards."
[2] European Medicines Agency (EMA). "Guidelines on Quality of Active Substances."
[3] Pharmaceutical Technology. "Global APIs Market Trends."
[4] CPhI Insights. "API Supplier Directory."
[5] Viatris Corporate Reports. "Supply Chain Strategy and Manufacturing Overview."
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