ryaltris: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746	NDA	HIKMA SPECIALTY USA INC.	59467-700-27	12 CARTON in 1 BOX (59467-700-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY	2022-08-15
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746	NDA	HIKMA SPECIALTY USA INC.	59467-700-84	12 CARTON in 1 BOX (59467-700-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY	2022-08-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Ryaltris, marketed as a treatment for allergic rhinitis and nasal symptoms, is a combination nasal spray formulated with olopatadine hydrochloride and mometasone furoate. Developed by Otonomy Inc., Ryaltris has gained regulatory approval in various markets, including the United States and Europe. As the demand for effective allergy remedies continues to rise globally, understanding the supplier landscape behind Ryaltris is crucial for industry stakeholders, investors, and healthcare providers.

This article provides a comprehensive overview of the suppliers involved in the Ryaltris supply chain, focusing on the key components: active pharmaceutical ingredients (APIs), excipients, manufacturing, and packaging materials. Additionally, it analyzes how supply chain dynamics impact drug availability, cost, and strategic positioning.

Active Pharmaceutical Ingredient (API) Suppliers

The core of Ryaltris relies on two APIs:

Olopatadine Hydrochloride
Mometasone Furoate

Olopatadine Hydrochloride

As an antihistamine nasal spray component, olopatadine hydrochloride’s API is sourced from multiple global suppliers, primarily specializing in antihistamine ingredients. Major manufacturers include:

Sagent Pharmaceuticals: A leading producer of olopatadine API, with facilities approved by regulatory agencies such as the FDA and EMA. Their APIs are used in multiple generic and branded formulations globally.
Adare Pharmaceuticals: Specializes in allergy and respiratory APIs, including olopatadine, supplying to both branded and generic manufacturers.
Mitsubishi Chemical Corporation: A Japanese supplier providing high-quality olopatadine APIs, primarily serving Asian markets.
Sigma-Aldrich (Merck): Offers olopatadine intermediates and APIs for research and commercial use, though most commercial supplies are sourced from other manufacturers.

Mometasone Furoate

Mometasone furoate is a corticosteroid used for its anti-inflammatory properties. Leading API manufacturers include:

GlaxoSmithKline (GSK): Historically, the original developer of mometasone, GSK supplies or licenses the API to authorized manufacturers.
Famar, Kureha Corporation, and Ferring Pharmaceuticals are known suppliers of mometasone furoate to the generics market, with facilities adhering to strict GMP standards.
Cayman Chemical and Carbosynth also provide mometasone intermediates and APIs, catering to both industrial and research sectors.

Supply Chain Considerations

The APIs for Ryaltris are predominantly sourced from manufacturers with extensive Good Manufacturing Practice (GMP) certification, ensuring compliance with regulatory standards. Given the complexity of APIs, especially corticosteroids and antihistamines, suppliers with robust facilities and proven quality track records maintain market advantages. Supply disruptions, such as those experienced during the COVID-19 pandemic, caused temporary shortages or delays, highlighting the importance of diverse sourcing strategies.

Excipients and Formulation Components

Ryaltris’s nasal spray formulation includes excipients such as benzalkonium chloride (preservative), in addition to the primary APIs:

Preservatives and Stabilizers: Suppliers like Merck KGaA and Symrise provide benzalkonium chloride and other stabilizers, which are critical for product stability and shelf life.
Propellants and Delivery Devices: Assembly of nasal spray devices involves specialized suppliers like AptarGroup, Nemera, and West Pharmaceutical Services, which supply the spray pumps, nasal cannulas, and metered-dose inhaler components.
Other Excipients: Lilac chemicals, emollients, and viscosity modifiers are sourced from established excipient manufacturers such as BASF and Dow Chemical.

Manufacturing and Contract Manufacturing Organizations (CMOs)

The complex synthesis and formulation of Ryaltris often involve contract manufacturing. Major CMOs involved include:

Recipharm: Known for contract manufacturing of nasal sprays, providing formulation, fill-finish, and packaging services.
Samsung Biologics and Lonza: While primarily focused on biologics, these organizations have expanded into small-molecule manufacturing, including nasal spray APIs.
Hospira (Part of Pfizer) and Catalent: Provide aseptic filling, packaging, and logistics services globally.

Regulatory and Quality Assurance

Manufacturers involved in the Ryaltris supply chain must adhere to stringent regulatory standards, including FDA cGMP and EMA Good Distribution Practices. Supply chain integrity is maintained through validation processes, stability testing, and batch traceability.

Packaging Material Suppliers

Final packaging involves high-precision components such as:

Nasal spray bottles and pumps: Suppliers like AptarGroup and West Pharmaceutical Services provide customized nasal spray delivery systems with embedded dose counters and anti-contamination features.
Labels and Cartons: Packaging manufacturers like Huhtamaki and UPM-Kymmene supply environmentally sustainable materials conforming to pharma packaging regulations.

Efficient packaging suppliers enable Ryaltris to meet stability, safety, and ease-of-use standards, directly impacting patient adherence and satisfaction.

Supply Chain Dynamics and Market Impact

The supply of Ryaltris hinges on the secure availability of high-quality APIs, excipients, and packaging materials. Market exclusivity for certain APIs, patent protections, and licensing agreements influence supplier choice and costs. As competition intensifies among generic and biosimilar manufacturers, sourcing strategies adapt to mitigate risks, diversify supply sources, and optimize costs.

Recent supply disruptions, exemplified during global health crises, prompted manufacturers to reassess their supplier networks, seeking resilient, multi-source strategies to secure continuous Ryaltris availability.

Strategic Implications for Stakeholders

Manufacturers: Should prioritize supplier diversification, rigorous qualification processes, and logistical agility to minimize risks.
Investors: Interested in supplier partnerships and supply chain stability as key indicators of Ryaltris’s market growth potential and profitability.
Regulators: Require transparency and compliance from suppliers to ensure product safety and efficacy.

Key Takeaways

The Ryaltris supply chain involves multiple tier-1 suppliers of APIs, excipients, packaging, and manufacturing services, primarily in North America, Europe, and Asia.
Ensuring continuous supply of high-quality APIs like olopatadine hydrochloride and mometasone furoate requires robust qualification, regulatory compliance, and diversification.
Packaging and device manufacturers are integral to Ryaltris’s delivery, with innovative, patient-friendly designs crucial for market success.
Global supply chain disruptions highlight the importance of strategic sourcing and inventory management.
Stakeholders should closely monitor supplier performance, regulatory changes, and geopolitical factors influencing the pharmaceutical supply landscape.

FAQs

1. Who are the primary API suppliers for Ryaltris?
Leading API suppliers include Sagent Pharmaceuticals and Adare Pharmaceuticals for olopatadine hydrochloride, and Famar, Kureha Corporation, and Ferring Pharmaceuticals for mometasone furoate.

2. How do supply chain disruptions affect Ryaltris availability?
Disruptions in API or excipient supply chains can lead to manufacturing delays, shortages, and increased costs, emphasizing the need for diversified sourcing strategies.

3. What role do packaging suppliers play in the Ryaltris supply chain?
They provide customized nasal spray devices, ensuring dose accuracy, safety, and ease of use, influencing patient adherence and regulatory compliance.

4. Are there regional differences in suppliers for Ryaltris?
Yes, APIs are sourced globally, with Asian manufacturers dominating certain markets; European and North American suppliers handle others, driven by regulatory, logistical, and cost factors.

5. What trends are influencing future supplier strategies for Ryaltris?
Increasing focus on supply chain resilience, digitalization, and regulatory harmonization are shaping strategic sourcing, with a shift toward multi-source and geographically diversified suppliers.

References

[1] U.S. Food and Drug Administration. “Olopatadine Hydrochloride API Data Sheets.” FDA, 2022.
[2] European Medicines Agency. “Guidelines on the Manufacture of Mometasone Furoate.” EMA, 2022.
[3] Sagent Pharmaceuticals Official Website. “API Supplier Profile,” 2023.
[4] Famar Pharmaceuticals. “API Manufacturing Capabilities,” 2023.
[5] AptarGroup. “Nasal Spray Packaging Solutions,” 2022.

End of Article

Suppliers and packagers for ryaltris

ryaltris

Suppliers for the Pharmaceutical Drug: Ryaltris