xelpros: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185	NDA	Sun Pharmaceutical Industries, Inc.	47335-317-90	1 BOTTLE, DROPPER in 1 BOX (47335-317-90) / 2.5 mL in 1 BOTTLE, DROPPER	2018-09-12
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185	NDA	Sun Pharmaceutical Industries, Inc.	47335-317-92	3 BOTTLE, DROPPER in 1 BOX (47335-317-92) / 2.5 mL in 1 BOTTLE, DROPPER	2018-09-12
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185	NDA	Sun Pharmaceutical Industries, Inc.	47335-317-94	3 BOTTLE, DROPPER in 1 BOX (47335-317-94) / 2.5 mL in 1 BOTTLE, DROPPER	2018-09-12
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185	NDA	Sun Pharmaceutical Industries, Inc.	47335-317-98	1 BOTTLE, DROPPER in 1 BOX (47335-317-98) / 2.5 mL in 1 BOTTLE, DROPPER	2018-09-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

XELPROS (latisse (bimatoprost ophthalmic solution) 0.03%) is a prescription medication approved for the treatment of inadequate or insufficient eyelashes, a condition clinically termed hypotrichosis of the eyelashes. As a leading product in the cosmetic ophthalmology segment, particularly in eyelash enhancement, XELPROS is a strategic offering for pharmaceutical companies. This analysis explores the suppliers involved in the manufacturing and distribution of XELPROS, evaluates their roles within the supply chain, and examines market dynamics affecting supply stability and quality.

Manufacturers and Supply Chain Structure

Allergan (AbbVie’s Portfolio)

Initially developed and marketed by Allergan, XELPROS is a proprietary formulation of bimatoprost ophthalmic solution. Allergan, a subsidiary of AbbVie since 2020, served as the primary manufacturer and supplier of this drug. The company's manufacturing facilities are located globally, adhering to stringent Good Manufacturing Practices (GMP) — a crucial requirement for ophthalmic solutions due to their sensitive nature.

Active Pharmaceutical Ingredient (API) Suppliers

At the core of XELPROS supply are the raw material suppliers of bimatoprost, the active pharmaceutical ingredient. Bimatoprost is a synthetic prostaglandin analog synthesized through complex chemical processes. The prominent API suppliers for bimatoprost include:

Sogang Pharmaceutical Co., Ltd. (South Korea): A notable API producer specializing in prostaglandin derivatives. Their manufacturing process involves advanced chemical synthesis techniques optimized for high purity and consistency.
Siyang Pharmaceutical (China): A significant player offering bulk API manufacturing, with an expanding global footprint in ophthalmic APIs.
Cayman Chemical (USA): While primarily a research supplier, Cayman supplies high-grade chemicals that occasionally serve as initial raw materials or intermediates in API synthesis.

Many companies rely on Contract Manufacturing Organizations (CMOs) across Asia for large-volume API manufacturing, leveraging cost efficiencies while maintaining quality standards.

Formulation and Packaging Suppliers

The formulation of XELPROS involves blending the API with preservative agents and stabilizers under controlled environments. Packaging suppliers provide the sterile ophthalmic bottles, dropper assemblies, and secondary packaging materials:

Gerresheimer (Germany): A global leader in pharmaceutical packaging, offering sterile ophthalmic vials and dropper bottles that ensure product stability and ease of use.
Ompi (Italy): Specializes in glass containers used for ophthalmic drugs, ensuring compatibility with sensitive formulations.

Distribution Partners

Post-manufacture, distribution is managed through a network of wholesale distributors and specialty pharmacies. Key distribution partners include:

McKesson Corporation: A major North American distributor responsible for timely delivery to healthcare providers.
AmerisourceBbergen (now part of AmerisourceBergen): Handles international shipping and compliant distribution channels.
Direct-to-Consumer Channels: In some markets, branded pharmacies and online platforms facilitate direct access.

Supply Chain Dynamics and Market Factors

The supply of XELPROS hinges on multiple interconnected elements:

API Availability and Quality: Production of bimatoprost requires highly specialized chemical synthesis, with stringent quality controls to ensure ophthalmic safety. Disruptions in API supply, such as factory closures or raw material shortages, can lead to supply constraints.
Regulatory Compliance: All manufacturing steps must comply with global FDA, EMA, and other regulatory authority standards. Regulatory delays or audits can disrupt supply chains.
Manufacturing Capacity: Especially during periods of increased demand, such as marketing campaigns or global health events, manufacturing capacities are tested. Allergan's investment in scalable production lines plays a pivotal role in meeting global demand.
Intellectual Property (IP) and Licensing: Since XELPROS is a proprietary formulation, licensing agreements influence the supply chain. Any patent disputes or licensing issues can impact production rights and supply continuity.
Supply Chain Resilience: The COVID-19 pandemic highlighted vulnerabilities in global pharmaceutical supply chains. Companies are now diversifying API sources and manufacturing sites to mitigate risks.

Key Suppliers and Their Role in Quality and Compliance

Given the ophthalmic nature of XELPROS, suppliers must adhere to the highest standards:

API Suppliers: Must maintain high purity (>99%) and batch-to-batch consistency. Regulatory bodies require extensive documentation and validation of production processes.
Packaging Providers: Sterility, stability, and material compatibility are paramount. Suppliers often work under cGMP conditions with validation protocols.
Logistics Partners: Temperature-controlled logistics are essential to preserve product integrity during transit.

Emerging Trends and Market Implications

Market trends indicating increased demand for eyelash enhancement products drive supply chain investments. These include:

Expanding Geographies: Growing markets across Asia-Pacific, Latin America, and the Middle East demand an expanded supplier base.
Biosimilars and Generics: Although XELPROS remains proprietary, biosimilar entries could influence suppliers' strategies and market dynamics.
Sustainability Initiatives: Suppliers are increasingly adopting sustainable manufacturing practices, which impact procurement and supplier selection processes.

Conclusion

The supply landscape for XELPROS involves a complex network curated to balance quality, regulatory compliance, and cost-efficiency. Core suppliers include high-grade API manufacturers, specialized formulation and packaging providers, and distribution partners able to meet global demand. Stability and quality in this supply chain are critical to maintaining product availability and ensuring patient safety. Strategic partnerships, diversified sourcing, and adherence to regulatory standards remain essential for safeguarding the supply chain of this niche yet high-value ophthalmic product.

Key Takeaways

Robust API sourcing is paramount, given its critical role in ensuring the quality and supply continuity of XELPROS.
Diversification of manufacturing and sourcing mitigates risks from geopolitical or supply disruptions.
Regulatory compliance and quality assurance at every supply chain node prevent product recalls and safeguard brand reputation.
Emerging markets increasingly influence supply chain strategies, leading to expanded supplier networks and localized manufacturing.
Innovation in packaging and logistics enhances stability and patient compliance, further supporting market growth.

FAQs

1. Who are the primary API suppliers for bimatoprost used in XELPROS?
Major API producers include Sogang Pharmaceutical (South Korea), Siyang Pharmaceutical (China), and Cayman Chemical (USA). These suppliers provide high-purity bimatoprost essential for ophthalmic applications.

2. How does regulatory compliance influence supplier selection for XELPROS?
Suppliers must adhere to strict GMP standards and demonstrate consistent quality, as ophthalmic drugs require high safety profiles. Regulatory audits and validation processes heavily influence supplier qualification.

3. Are there opportunities for new suppliers in the XELPROS supply chain?
Yes. As demand grows, especially in emerging markets, there are opportunities for qualified API manufacturers and packaging providers to enter the supply chain, provided they meet stringent quality standards.

4. How has the COVID-19 pandemic affected the supply of XELPROS?
Disruptions in global logistics and manufacturing have temporarily impacted supply. Companies have responded by diversifying sources and increasing inventory buffers to preserve supply stability.

5. What role do packaging suppliers play in ensuring the safety of XELPROS?
Packaging suppliers provide sterile, compatible containers essential for ophthalmic solutions. High-quality packaging minimizes contamination risk and ensures product stability throughout its shelf life.

References

[1] AbbVie. (2022). XELPROS (bimatoprost ophthalmic solution) prescribing information.
[2] U.S. Food and Drug Administration. (2021). Drug Approval Package: Lumigan (bimatoprost).
[3] Sogang Pharmaceutical Co., Ltd. Official Website. (2023). API manufacturing capabilities.
[4] International Journal of Pharmaceutical Sciences. (2020). Assessment of global supply chains for ophthalmic drugs.
[5] McKesson Corporation. Corporate Overview. (2022). Pharmaceutical distribution services.

Suppliers and packagers for xelpros

xelpros

Suppliers for the Pharmaceutical Drug: XELPROS