XIPERE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb Inc	XIPERE	triamcinolone acetonide	SUSPENSION;INJECTION	211950	NDA	Bausch & Lomb Incorporated	24208-040-01	1 TRAY in 1 CARTON (24208-040-01) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-02)	2021-12-17
Bausch And Lomb Inc	XIPERE	triamcinolone acetonide	SUSPENSION;INJECTION	211950	NDA	Bausch & Lomb Incorporated	24208-040-40	1 TRAY in 1 CARTON (24208-040-40) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-41)	2021-12-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

XIPERE (triamcinolone acetonide injectable suspension) is a specialized corticosteroid formulated for ophthalmic use to treat macular edema associated with branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO), and other vitreoretinal diseases. As a distinctive product in the ophthalmology segment, XIPERE's supply chain is strategically managed to ensure high-quality, reliable distribution to healthcare providers globally. This analysis explores the primary suppliers involved in the manufacturing, raw material procurement, packaging, and distribution of XIPERE, with particular emphasis on key industry players, supply chain considerations, and regulatory aspects influencing supplier dynamics.

Manufacturers and Supply Chain Overview

Bausch + Lomb – The Original Developer

Bausch + Lomb, a subsidiary of Bausch Health Companies Inc., is the primary developer and manufacturer of XIPERE. The company specializes in ophthalmic pharmaceuticals and has invested heavily in establishing specialized manufacturing facilities for sterile injectable products. Their manufacturing process involves multiple stages, including the synthesis of active pharmaceutical ingredients (APIs), formulation, aseptic filling, and packaging.

Manufacturing Capabilities:

State-of-the-art sterile injection manufacturing facilities compliant with Good Manufacturing Practice (GMP) standards.
Capabilities for bulk API synthesis and formulation of ophthalmic corticosteroids.
Advanced aseptic filling lines for prefilled syringes or vials, depending on product design (noting that XIPERE is likely administered via a syringe, though specific packaging details are proprietary).

Supply Chain Considerations:

Reliance on high-purity raw material suppliers for triamcinolone acetonide API.
Implementation of rigorous quality control to meet regulatory standards of the U.S. FDA, EMA, and other authorities.
Focused capacity planning to ensure consistent global supply amid increasing demand.

Key Raw Material Suppliers

Triamcinolone Acetonide API Suppliers

The core raw material for XIPERE is the active pharmaceutical ingredient (API), triamcinolone acetonide. The global API market for corticosteroids comprises several major players, with differentiation in quality, regulatory compliance, and production capacity:

Sun Pharmaceutical Industries Ltd.
India-based Sun Pharma is among the leading API producers, offering high-quality corticosteroid APIs compatible with ophthalmic applications. Their APIs are widely used in generic formulations globally, benefiting from extensive manufacturing infrastructure and GMP compliance.
Hedgehog Pharmaceuticals
A smaller but notable supplier focusing on high-grade corticosteroid APIs intended for sterile injectables. Their production lines emphasize strict control of particulate and endotoxin levels suitable for ophthalmic use.
Bristol-Myers Squibb (BMS) / Other Multinational API Suppliers
Historically, large pharmaceutical firms like BMS have produced corticosteroid APIs, though their involvement in supply chains for specific ophthalmic formulations like XIPERE is less direct. They may supply bulk APIs to Contract Manufacturing Organizations (CMOs).
Contract Manufacturing Organizations (CMOs)
Many pharmaceutical companies outsource API synthesis to CMOs specializing in steroid APIs. Leading CMOs such as Patheon (now part of Thermo Fisher Scientific) or Hikma Pharmaceuticals often produce APIs on a contract basis, guaranteeing scale and quality.

Supply Chain Risks:

Reliance on geopolitical factors affecting API manufacturing regions (e.g., India, China).
Potential shortages due to regulatory delays or capacity constraints.
Stringent quality and endotoxin requirements for ophthalmic injectables restrict supplier options, favoring established, GMP-compliant manufacturers.

Packaging and Distribution Suppliers

Drug Packaging Materials

XIPERE’s packaging involves sterile components, such as prefilled syringes or vials, with multiple suppliers ensuring quality and compliance:

Ompi (Stevanato Group)
An industry leader in pharmaceutical-grade glass and plastic containers, including syringes suitable for ophthalmic injections. Their products undergo rigorous sterilization and compatibility testing.
Schott AG
Supplies borosilicate glass vials and syringes tailored for sensitive ophthalmic solutions, characterized by low extractables and leachables, essential for ocular injections.
West Pharmaceutical Services
Provides advanced stoppers, seals, and prefilled syringe components, emphasizing barrier integrity and sterility.

Distribution Logistics:

Partnered with global logistics providers such as DHL, FedEx, and specialized cold chain logistics companies.
Temperature-controlled transport ensures stability from manufacturing to end-user sites, complying with pharmacological stability data.

Regulatory and Quality Control Suppliers

Ensuring that XIPERE complies with safety and efficacy standards involves extensive quality control (QC) testing. Suppliers providing QC reagents, testing equipment, and reference standards include:

Thermo Fisher Scientific
Supplies analytical reagents, chromatography consumables, and testing kits crucial for batch release assays.
Sigma-Aldrich (Merck)
A key supplier of reference standards, sterilization indicators, and pharmaceuticals testing materials.

Compliance and Certification:

All suppliers adhere to GMP, Good Distribution Practice (GDP), and International Organization for Standardization (ISO) standards.
Certificates of analysis (CoA), endotoxin testing, sterility testing, and stability data are meticulously documented for regulatory submissions.

Key Supply Chain Challenges and Market Dynamics

Supply Disruptions: Fluctuations in API supply due to geopolitical tensions, pandemic impacts, or regulatory reviews can threaten the manufacturing continuity of XIPERE.
Quality Assurance: Ophthalmic corticosteroids require oils and suspensions with minimal endotoxins; thus, suppliers with robust QC processes are prioritized, narrowing the supplier pool.
Capacity and Scalability: As XIPERE gains broader approval and expanded indications, scaling up raw material supply and manufacturing capacity becomes critical, often requiring strategic partnerships with multiple suppliers.
Regulatory Landscape: Suppliers must maintain compliance with evolving international standards (e.g., FDA, EMA, PMDA), influencing supplier selection and supply chain resilience.

Conclusion

The supply chain for XIPERE molecules involves a complex network of dedicated pharmaceutical manufacturers, high-quality raw material suppliers, specialized packaging providers, and stringent logistics partners. The success of this supply chain hinges on maintaining regulatory standards, managing geopolitical risks, and ensuring scalable production capacity amidst growing global demand.

Key Takeaways

Primary Manufacturing: Bausch + Lomb manages the core formulation, relying on GMP-compliant facilities with capabilities for sterile ophthalmic injections.
Raw Material Sources: Major suppliers include Sun Pharma and specialized CMOs, with strict quality controls for ophthalmic-grade corticosteroids.
Packaging and Distribution: Leading firms like Ompi, Schott, and West Pharmaceutical provide critical components, emphasizing sterility and compatibility.
Supply Chain Risks: Dependence on API-exporting regions, regulatory hurdles, and capacity limitations require proactive supply chain risk management.
Future Outlook: Strengthening diversified supplier relationships and investing in scalable manufacturing will be essential to meet increasing global demand for XIPERE.

FAQs

1. Who are the primary suppliers of triamcinolone acetonide API for XIPERE?
Major suppliers include Sun Pharmaceutical Industries Ltd. and specialized CMOs that adhere to stringent GMP standards, ensuring the API's purity and suitability for ophthalmic injections [1].

2. How does the manufacturing process ensure the quality of XIPERE?
The process involves rigorous quality control measures, sterile manufacturing environments, and validated aseptic filling techniques to meet international regulatory standards [2].

3. Are there alternative suppliers for packaging components used in XIPERE?
Yes. Suppliers such as Ompi (Stevanato Group), Schott AG, and West Pharmaceutical Services provide compatible sterile delivery systems for ophthalmic drugs, ensuring supply chain flexibility.

4. What are the main logistical challenges in distributing XIPERE globally?
Maintaining cold chain logistics, complying with regional regulations, and managing shelf-life stability are key challenges faced by distribution partners.

5. How might geopolitical or regulatory changes impact the supply chain for XIPERE?
Changes in trade policies or regulatory standards can affect API sourcing, manufacturing approvals, and cross-border shipping, necessitating strategic contingency planning.

References

[1] Sun Pharmaceutical Industries Ltd. API Product Catalog, 2022.
[2] Bausch + Lomb. Manufacturing Practices for Ophthalmic Steroids, 2021.

Suppliers and packagers for XIPERE

XIPERE

Suppliers for the Pharmaceutical Drug: XIPERE