Suppliers and packagers for inveltys

inveltys

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon Labs Inc	INVELTYS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210565	NDA	ALCON LABORATORIES, INC.	71571-121-20	2.8 mL in 1 BOTTLE, DROPPER (71571-121-20)	2018-08-22
Alcon Labs Inc	INVELTYS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210565	NDA	ALCON LABORATORIES, INC.	71571-121-28	1 BOTTLE, DROPPER in 1 CARTON (71571-121-28) / 2.8 mL in 1 BOTTLE, DROPPER	2018-08-22

Suppliers for the Pharmaceutical Drug: INVELTYS

Last updated: July 29, 2025

Introduction

INVELTYS (loteprednol etabonate ophthalmic suspension) is a prescription corticosteroid formulated to treat postoperative inflammation and pain associated with ocular surgery. Approved by the U.S. Food and Drug Administration (FDA) in 2018, INVELTYS has become a significant product in ophthalmology, particularly for ophthalmic surgical recovery. As the demand for this drug grows, understanding its supply chain and key suppliers becomes critical for stakeholders including healthcare providers, distributors, and investors. This analysis delves into the manufacturing landscape, supply chain dynamics, and primary suppliers involved in the production of INVELTYS.

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Manufacturing and Formulation Overview

INVELTYS is developed and marketed by Kala Pharmaceuticals, a biopharmaceutical company specializing in innovative ocular therapies. The active pharmaceutical ingredient (API), loteprednol etabonate, is a corticosteroid with a favorable safety profile, formulated as an ophthalmic suspension with proprietary delivery technology.

The manufacturing of INVELTYS involves multiple suppliers specializing in the synthesis of APIs, excipients, and specialized formulation components. Given the complexity of ophthalmic drug production, the supply chain necessitates high-quality standards and regulatory compliance across all suppliers to ensure product safety and efficacy.

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Key Suppliers of Active Pharmaceutical Ingredient (API)

Loteprednol etabonate, the API in INVELTYS, is synthesized typically in specialized chemical manufacturing facilities across North America, Europe, and Asia. Although Kala Pharmaceuticals does not publicly disclose all API suppliers, industry patterns suggest the following key players:

• BASF: A major supplier of pharmaceutical-grade chemicals and APIs, BASF has facilities capable of producing corticosteroid APIs to strict regulatory standards. Its extensive global network supports high-volume, reliable supply chains essential for ophthalmic products like INVELTYS.

• Suzuki (JRS Pharma): Known for producing corticosteroid APIs, JRS Pharma offers high-purity loteprednol etabonate synthesis, suitable for ophthalmic formulations. Their expertise in corticosteroid chemistry aligns with the quality requirements for INVELTYS.

• TAPI (Tapi Industries): An Indian chemicals manufacturer with API production capabilities and low-cost manufacturing, TAPI supplies APIs to global markets, including corticosteroids. Their role in INVELTYS's supply chain is speculative but plausible given industry trends.

Note: The exact API suppliers for INVELTYS remain proprietary, with Kala Pharmaceuticals likely relying on multiple validated suppliers to mitigate supply risks.

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Excipients and Formulation Components

INVELTYS’s formulation includes various excipients such as preservatives, stabilizers, and suspending agents. Notable suppliers in this area include:

• Dow Chemical (now Dow Inc.): Supplies pharmaceutical-grade excipients and stabilizers critical to ophthalmic suspensions. Their broad catalog includes surfactants, viscosity modifiers, and preservatives.

• Ashland Global Holdings: Offers specialty excipients, such as viscosity-modifying agents and buffers compatible with ophthalmic formulations.

• Daicel Corporation: Produces sterilization-friendly excipients and preservatives formulated specifically for ophthalmic use.

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Manufacturing and Packaging Facilities

Kala Pharmaceuticals operates its own production facilities for the manufacturing, aseptic processing, and packaging of INVELTYS. To meet stringent quality control standards, the company partners with contract manufacturing organizations (CMOs) possessing advanced sterile manufacturing capability.

Key external partners may include:

• Lonza: A global leader in API synthesis and contract manufacturing, including ophthalmic products.

• Recipharm: Specializes in sterile ophthalmic formulations and high-quality fill/finish operations.

These partnerships ensure scalability and compliance with Good Manufacturing Practices (GMP), vital for ophthalmic corticosteroids.

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Supply Chain Dynamics and Risks

Given the critical nature of ophthalmic medications, the supply chain for INVELTYS incorporates multiple layers:

• Multiple API suppliers: To reduce risk, companies often source APIs from more than one manufacturer, maintaining continuity amid geopolitical or supply disruptions.

• Global procurement: Sourcing excipients and formulation components internationally helps optimize costs but introduces additional risks related to customs, tariffs, and geopolitical stability.

• Regulatory Compliance: Suppliers must adhere to GMP, ISO standards, and regional regulatory frameworks (FDA, EMA, etc.). Regulatory compliance influences supplier selection and ongoing quality assurance processes.

Risks include dependency on specific suppliers, geopolitical tensions disrupting raw material supply, or manufacturing delays. Building a robust supply chain with diversified suppliers is essential for continuous availability.

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Strategic Suppliers and Industry Trends

Major pharmaceutical companies producing corticosteroid APIs, such as BASF and JRS Pharma, are integral to the supply of raw materials like loteprednol etabonate globally. Contract manufacturing organizations facilitating sterile ophthalmic formulations, including Lonza and Recipharm, play vital roles in ensuring manufacturing scalability and quality.

Furthermore, there is an increasing trend toward vertical integration or strategic partnerships to secure supply chains, driven by the rising demand for ophthalmic corticosteroids post-surgical.

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Pricing and Market Impact of Supplier Relationships

The number and quality of suppliers directly influence the pricing, availability, and competitive positioning of INVELTYS. Efficient supply chains enable Kala Pharmaceuticals to manage costs and ensure transparent pricing. Conversely, supply disruptions could lead to shortages, affecting physician prescribing patterns and patient access.

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Regulatory and Quality Assurance

Suppliers involved in the manufacturing of INVELTYS must comply with stringent regulatory standards. The FDA and EMA conduct regular audits, and suppliers must maintain validation records, batch consistency, and safety data. This compliance underscores the importance of select, validated suppliers with proven track records.

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Conclusion

The supply chain for INVELTYS encompasses multiple tiers: API manufacturers, excipient suppliers, and contract manufacturing organizations. While specific supplier identities remain proprietary, industry patterns highlight significant involvement from companies such as BASF, JRS Pharma, Dow Inc., Ashland, and Lonza. Ensuring a diversified, compliant, and responsive supply base is essential to maintain the availability of INVELTYS amid increasing demand and evolving regulatory landscapes.

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Key Takeaways

• Primary API suppliers, including industry leaders like BASF and JRS Pharma, are likely involved but remain undisclosed.
• Diversification of suppliers for APIs and excipients minimizes risks associated with production disruptions.
• Strategic partnerships with CMOs like Lonza and Recipharm are vital for sterile ophthalmic manufacturing scalability.
• Regulatory compliance is a critical factor influencing supplier selection and quality assurance.
• Supply chain resilience underpins the market stability and pricing of INVELTYS amid growing ophthalmic surgical needs.

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FAQs

1. Are the API suppliers for INVELTYS publicly disclosed?
No, the specific API suppliers for INVELTYS have not been publicly disclosed. However, industry analysts suggest involvement of major chemical manufacturers like BASF and JRS Pharma, based on industry patterns and procurement standards.

2. How does supply chain diversification impact the availability of INVELTYS?
Diversifying suppliers reduces dependency on single sources, minimizing risks of shortages due to geopolitical, logistical, or manufacturing issues, thus maintaining consistent product availability.

3. What role do contract manufacturing organizations play in INVELTYS production?
CMOs like Lonza and Recipharm provide sterile filling and final formulation services, ensuring scalable and compliant manufacturing of INVELTYS batches.

4. How important is regulatory compliance for suppliers involved in INVELTYS?
Regulatory compliance is critical; suppliers must meet GMP and other standards mandated by agencies such as the FDA and EMA to ensure the safety, efficacy, and quality of the ophthalmic product.

5. Are there risks associated with the global supply chain of ophthalmic corticosteroids?
Yes, risks include geopolitical tensions, raw material shortages, manufacturing delays, and regulatory hurdles. Building resilient, diversified supply chains mitigates these risks.

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References

1. FDA. (2018). Indication for INVELTYS (loteprednol etabonate ophthalmic suspension).
2. Kala Pharmaceuticals. (2022). Corporate website and product pipeline information.
3. Industry reports on ophthalmic drug manufacturing.
4. BASF. (2021). API production and pharmaceutical chemicals.
5. JRS Pharma. (2022). Corticosteroid API manufacturing capabilities.