Suppliers and packagers for vuity

vuity

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	214028	NDA	AbbVie Inc.	0074-7098-01	1 BOTTLE in 1 BOX (0074-7098-01) / 2.5 mL in 1 BOTTLE (0074-7098-02)	2021-10-28
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	214028	NDA	AbbVie Inc.	0074-7098-03	3 BOTTLE in 1 BOX (0074-7098-03) / 2.5 mL in 1 BOTTLE (0074-7098-02)	2021-10-28
Abbvie	VUITY	pilocarpine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	214028	NDA	AbbVie Inc.	0074-7098-04	1 BOTTLE in 1 CARTON (0074-7098-04) / 2.5 mL in 1 BOTTLE (0074-7098-02)	2021-10-28

Suppliers for the Pharmaceutical Drug: Vuity

Last updated: July 27, 2025

Introduction

Vuity, a novel ophthalmic solution formulated for the treatment of presbyopia, has garnered significant attention in the pharmaceutical landscape since its approval by the FDA. As a prescription eye drop developed by Allergan Aesthetics, a division of AbbVie Inc., Vuity represents a breakthrough approach to managing age-related near vision loss, offering an alternative to corrective lenses and surgical solutions. Understanding the supply chain for Vuity—spanning active pharmaceutical ingredient (API) sourcing, formulation components, packaging, and distribution—is essential for stakeholders aiming to evaluate market sustainability, risk, and competitive positioning. This analysis provides a comprehensive overview of Vuity’s key suppliers, emphasizing critical supply chain components, strategic partnerships, and potential vulnerabilities.

Active Pharmaceutical Ingredient (API) Suppliers

Pilocarpine as the API

Vuity's primary active component is pilocarpine, a parasympathomimetic agent historically utilized in glaucoma therapy. The pharmaceutical industry relies on specific suppliers for high-quality pilocarpine to formulate Vuity’s eye drops. Notable API manufacturers include:

• Shaanxi Fuheng (Fuheng Pharma): A leading Chinese API producer with capabilities in pilocarpine synthesis, Fuheng has established supply agreements that cater to global pharmaceutical firms due to cost efficiency and reliable quality standards.
• Xinfa Pharmaceutical: Another Chinese manufacturer specializing in cholinergic compounds, Xinfa supplies high-purity pilocarpine under strict regulatory standards, including cGMP-compliant processes.
• Taj Pharmaceuticals: An Indian API manufacturer with a robust portfolio in ophthalmic active ingredients, Taj Pharmaceuticals offers pilocarpine with global regulatory approvals, including FDA and EMA.

Supply Chain Considerations

Global supply chain disruptions, such as COVID-19 impacts, geopolitical tensions, and regulatory shifts, influence API availability. Chinese and Indian suppliers dominate pilocarpine production, presenting geopolitical and quality control considerations. AbbVie's procurement strategies likely include diversified supplier relationships to mitigate risks associated with geographic concentration.

Formulation Components and Excipients

Vuity’s formulation includes various excipients that ensure stability, bioavailability, and proper eye drop function. Major suppliers for these components include:

• Preservatives: Such as benzalkonium chloride, sourced from chemical intermediates supplied by companies like Ashland or BASF.
• Buffer Solutions: Suppliers like Johnson Matthey and Evonik provide buffering agents to maintain pH stability.
• Viscosity-enhancing agents: Like hypromellose, supplied by Dow Chemical and Shin-Etsu Chemical, ensuring appropriate eye drop viscosity.

Regulatory compliance for excipients is critical; therefore, suppliers are often selected based on their proven track record of cGMP adherence and safety profiles.

Packaging and Delivery Systems

Vuity’s packaging involves sterile ophthalmic bottles, dropper tips, and secondary packaging. Key suppliers include:

• Amcor and Gerresheimer: Leading manufacturers of ophthalmic packaging solutions, providing sterilized, leak-proof bottles that meet regulatory standards.
• West Pharmaceutical Services: Supplies advanced sealing and closure systems to prevent contamination and maintain stability during transit.

Packaging contributes significantly to product stability, patient safety, and user experience, making supplier quality paramount.

Manufacturing and Contract Manufacturing Organizations (CMOs)

External manufacturing plays a vital role in scaling production:

• Catalent: Known for their expertise in sterile ophthalmic formulation manufacturing, Catalent likely supports large-scale production of Vuity.
• Recipharm: A European CMO with capabilities in ophthalmic drug production, potentially involved in formulation scaling or fill-finish processes.

AbbVie’s strategic partnerships with CMOs facilitate rapid scale-up while maintaining stringent quality standards. These alliances often involve technology transfer, process validation, and regulatory compliance management.

Distribution and Logistics

Efficient distribution channels are vital for timely patient access:

• Pharmaceutical wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen distribute Vuity to pharmacies nationwide.
• Logistics providers like DHL, FedEx, and UPS manage temperature-sensitive transport, ensuring product integrity.

Supply chain resilience hinges on the robustness of these distribution networks, especially considering the high-volume roll-out following regulatory approval.

Regulatory and Quality Assurance

Suppliers must meet rigorous regulatory standards, including:

• FDA cGMP compliance for APIs, excipients, and packaging components.
• ISO certifications (e.g., ISO 9001, 13485) for manufacturing and quality management.
• Audited supplier qualifications by AbbVie to uphold product safety and efficacy.

Compliance ensures the consistent quality of Vuity and uninterrupted supply cycles, crucial amidst increasing demand.

Potential Supply Chain Risks and Mitigation

• Geopolitical Tensions: Reliance on Chinese and Indian API suppliers introduces risks linked to tariffs, export restrictions, and geopolitical conflicts. Diversification strategies include establishing closer ties with alternative suppliers in Europe or North America.
• Regulatory Changes: Stricter API or excipient regulations could impact sourcing; proactive engagement with regulatory agencies mitigates these risks.
• Manufacturing Capacity Constraints: The burgeoning demand for presbyopia treatments strains manufacturing capacity, prompting AbbVie to expand its network of CMOs and increase inventory buffers.
• Supply Chain Disruptions: COVID-19 underscored the importance of diversifying sources and maintaining contingency inventories.

Conclusion

The supply chain for Vuity encompasses a complex network of high-quality API manufacturers, excipient suppliers, packaging providers, and logistical partners. The API, pilocarpine, is predominantly sourced from established Chinese and Indian producers, with strategic alliances helping ensure support during market expansion. Packaging and manufacturing involve specialized pharmaceutical firms with proven regulatory compliance. While the supply chain currently functions effectively, ongoing geopolitical, regulatory, and capacity challenges necessitate diligent risk management to sustain Vuity’s market presence.

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Key Takeaways

• Diverse API sourcing is essential to mitigate geopolitical risks; current reliance on Chinese and Indian suppliers highlights the need for contingency planning.
• Strategic partnerships with CMOs provide flexibility for scaling production and maintaining quality.
• Regulatory compliance across all supply chain stages is critical for product approval and patient safety.
• Robust logistics and distribution networks ensure timely delivery and availability.
• Proactive risk mitigation strategies include supplier diversification, capacity expansion, and regulatory engagement to safeguard supply continuity.

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FAQs

1. Who are the primary suppliers of pilocarpine for Vuity?
Chinese firms like Shaanxi Fuheng and Indian companies such as Taj Pharmaceuticals are major API suppliers, providing high-purity pilocarpine compliant with international standards.

2. How does AbbVie ensure quality across its Vuity supply chain?
AbbVie maintains rigorous qualification processes, requiring suppliers to meet cGMP standards, ISO certifications, and undergo regular audits to uphold global quality standards.

3. Are there alternative APIs or formulations for presbyopia treatment?
Currently, Vuity's active is pilocarpine; alternative compounds are under research but lack regulatory approval. Supply chain stability depends on pilocarpine sourcing.

4. What risks could disrupt Vuity’s supply chain?
Potential risks include geopolitical tensions, API shortages, manufacturing capacity constraints, regulatory changes, and global logistic disruptions.

5. How does supply chain management impact Vuity’s market access?
Efficient supply chain management ensures product availability, regulatory compliance, and cost control, directly influencing market penetration and patient access.

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Sources:

[1] Abbott Laboratories, "Vuity (pilocarpine hydrochloride ophthalmic solution) prescribing information," 2021.
[2] chemical and pharmaceutical industry reports, "Global API Market Analysis," 2022.
[3] U.S. FDA Database, "Approved Ophthalmic Drugs," 2023.
[4] Pharmaceutical supplier directories and public company disclosures.