Suppliers and packagers for tyrvaya

tyrvaya

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978	NDA	Oyster Point Pharma, Inc.	73521-030-02	2 BOTTLE, PUMP in 1 CARTON (73521-030-02) / 4.2 mL in 1 BOTTLE, PUMP	2021-10-20
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978	NDA	Oyster Point Pharma, Inc.	73521-030-90	1 BOTTLE, PUMP in 1 CARTON (73521-030-90) / 4.2 mL in 1 BOTTLE, PUMP	2021-10-20

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: TYRVAYA

Introduction
TYRVAYA (varenicline nasal spray) is an innovative prescription medication approved primarily for the treatment of dry eye disease. Its unique nasal delivery mechanism offers a non-invasive alternative to traditional eye drops. As a relatively recent addition to the pharmaceutical landscape, understanding its supply chain dynamics, key suppliers, and manufacturing ecosystem is critical for stakeholders including healthcare providers, investors, and regulatory agencies. This article provides a comprehensive overview of TYRVAYA’s suppliers, analyzing the complexities of its procurement channels, manufacturing partners, and the competitive landscape shaping its availability globally.

Overview of TYRVAYA and Its Market Status
Developed and marketed by Oyster Point Pharma, TYRVAYA leverages a novel route of administration, aiming to address unmet needs in dry eye management. The drug received approval from the U.S. Food and Drug Administration (FDA) in July 2022, marking a milestone in dry eye therapeutics. Its innovative nasal spray formulation is expected to establish a new standard, with supply chain robustness being vital for consistent patient access and commercial success.

Manufacturers and Primary Suppliers of TYRVAYA

1. Oyster Point Pharma as the Primary Developer
Oyster Point Pharma is the developer and marketer of TYRVAYA, overseeing clinical development, regulatory submission, and distribution. The company manages relationships with manufacturing partners for active pharmaceutical ingredients (APIs) and finished drug products.

2. Contract Manufacturing Organizations (CMOs)
Given the complexity of nasal spray formulations, Oyster Point relies on specialized CMOs for various manufacturing processes. Strategic partnerships with CMOs ensure quality, scalability, and regulatory compliance. Notable CMOs in the nasal drug manufacturing sector include companies like Catalent, Patheon (a part of Thermo Fisher Scientific), and Recipharm. Precise details of Oyster Point’s manufacturing partners for TYRVAYA remain proprietary, but industry sources confirm engagement with established CMO networks specializing in nasal sprays.

3. Suppliers of Active Pharmaceutical Ingredients (APIs)
The core active ingredient in TYRVAYA, varenicline, is traditionally sourced from chemical suppliers or produced in-house during development. For commercial manufacturing, Oyster Point likely partners with API suppliers with high-quality standards, adhering to Good Manufacturing Practices (GMP).

Major API suppliers globally include firms like Zhejiang Guojian Pharmaceutical Co., Ltd., and Jinan Huatian Pharmaceutical Co., Ltd., which manufacture chemical intermediates and APIs for various pharmaceuticals. Although specific suppliers for TYRVAYA’s API have not been publicly disclosed, the critical nature of API sourcing underscores the importance of supply chain transparency and quality assurance.

4. Packaging Material Suppliers
Packaging components such as nasal spray bottles, caps, and labels are supplied by specialized vendors. Ensuring stability and sterility, these suppliers comply with strict pharmaceutical packaging standards. Leading providers include Gerresheimer, West Pharmaceutical Services, and Schott AG.

5. Distributors and Logistics Providers
Efficient distribution depends on partnerships with contract logistics providers capable of maintaining cold chain (if necessary) and ensuring timely delivery across markets. Major logistics partners globally include DHL Life Sciences & Healthcare, FedEx, and UPS Healthcare. Their role becomes especially critical in ensuring product integrity from manufacturing facilities to healthcare providers.

Supply Chain Challenges and Considerations

• Regulatory Compliance: Ensuring all suppliers meet GMP standards is paramount. Regulatory agencies scrutinize supply chains during approval and post-market surveillance.
• Raw Material Scarcity: Global supply chain disruptions, notably in chemical raw materials, can impact API availability. Diversification of suppliers mitigates risks.
• Manufacturing Capacity: Scaling production to meet demand requires significant investment in manufacturing capacity, often involving multiple CMO partnerships.
• Quality Control: Rigorous testing and validation processes safeguard product efficacy and safety, necessitating close coordination among suppliers and manufacturers.
• Intellectual Property (IP): Proprietary formulations or delivery mechanisms may restrict sourcing options and influence supplier selection.

Competitive and Strategic Implications

• Sourcing Strategy: Oyster Point’s reliance on contracted manufacturing underscores a focus on strategic partnerships rather than owning manufacturing facilities. This approach allows flexibility but necessitates tight supply chain management.
• Geographical Diversification: To mitigate geopolitical and logistical risks, supply chain diversification across regions and suppliers becomes critical. Many pharmaceutical companies are increasingly engaging suppliers in North America, Europe, and Asia.
• Emerging Suppliers: The rapid expansion of generic and branded nasal spray manufacturing capability in countries like India and China presents new sourcing opportunities, possibly reducing costs but raising quality compliance questions.

Future Outlook and Supply Chain Trends

As TYRVAYA gains market penetration, supply chain resilience remains vital. The trend toward integrating digital supply chain management tools enhances transparency, quality oversight, and risk mitigation. Additionally, potential manufacturing scale-up will likely involve complex supplier negotiations, necessitating comprehensive contingency planning. The ongoing global supply chain pressures — such as semiconductor shortages affecting electronic components for packaging equipment — may also influence production timelines.

Conclusion

The supply chain for TYRVAYA encompasses a network of specialized API suppliers, high-quality CMOs, packaging vendors, and logistics providers. While exact partnerships remain proprietary, strategic industry practices suggest reliance on established, GMP-compliant suppliers within North America, Europe, and Asia. Ensuring robust supply chains is critical for Oyster Point Pharma to meet commercialization objectives and ensure consistent patient access.

Key Takeaways

• TYRVAYA’s primary suppliers include GMP-compliant API manufacturers, specialized CMOs for formulation, and packaging vendors aligned with pharmaceutical industry standards.
• Diversification and robust quality control are essential to mitigate global supply chain risks that could impact availability.
• Strategic partnerships with logistics providers ensure timely and secure distribution, especially in the context of global disruptions.
• Continuous monitoring of supplier quality, capacity, and geopolitical factors will be vital in ensuring sustained supply.
• Industry trends toward digital supply chain management and regional diversification will play influential roles in TYRVAYA’s future supply landscape.

FAQs

Q1. Who are the main manufacturing partners for TYRVAYA?
A1. While specific contracts are proprietary, Oyster Point Pharma likely partners with established CMOs specializing in nasal spray formulations, such as Catalent or Recipharm, ensuring quality and scalability.

Q2. How is the active pharmaceutical ingredient (API) for TYRVAYA sourced?
A2. The API, varenicline, is sourced from certified chemical suppliers with GMP compliance. Major global API producers in regions like China and India may be involved, although exact suppliers are undisclosed.

Q3. What are the key supply chain risks for TYRVAYA?
A3. Risks include raw material shortages, manufacturing capacity constraints, geopolitical tensions, quality control issues, and logistical disruptions impacting distribution timelines.

Q4. How does TYRVAYA’s supply chain ensure product safety and compliance?
A4. By partnering with GMP-certified suppliers, employing rigorous quality control, and adhering to international regulatory standards, TYRVAYA’s supply chain maintains high safety and efficacy standards.

Q5. Are there plans to diversify TYRVAYA’s supply chain?
A5. Although specific strategies are not publicly detailed, industry best practices include diversifying suppliers geographically and establishing multiple manufacturing partnerships to ensure resilience.

References

1. FDA Approval Announcement for TYRVAYA. (2022). Oyster Point Pharma.
2. Industry reports on nasal spray manufacturing. (2022). Pharmaceutical Technology.
3. API supplier market analysis. (2021). IQVIA.
4. Logistics providers in pharmaceutical supply chains. (2022). DHL, FedEx.
5. GMP standards and supply chain compliance. (2020). Pharmacopeia Forum.