NETARSUDIL MESYLATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon Labs Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254	NDA	Alcon Laboratories, Inc.	70727-497-25	1 BOTTLE in 1 CARTON (70727-497-25) / 2.5 mL in 1 BOTTLE	2017-12-18
Alcon Labs Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254	NDA	Alcon Laboratories, Inc.	70727-497-99	1 BOTTLE in 1 CARTON (70727-497-99) / 2.5 mL in 1 BOTTLE	2017-12-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: October 20, 2025

Introduction

Netarsudil mesylate, marketed under the brand name Rhopressa, is a topical ocular hypotensive agent approved by the U.S. Food and Drug Administration (FDA) for reducing intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. As a Rho kinase inhibitor, it enhances aqueous humor outflow through the trabecular meshwork, providing an alternative mechanism to traditional therapies like beta-blockers, prostaglandin analogs, and alpha agonists. The global landscape for suppliers of netarsudil mesylate encompasses pharmaceutical manufacturers, specialty chemical traders, and intermediaries. This report meticulously examines these suppliers, focusing on their manufacturing capabilities, geographic presence, regulatory compliance, and strategic positioning within the ophthalmic pharmaceutical supply chain.

Manufacturers of Netarsudil Mesylate

1. Aerie Pharmaceuticals

Overview:
Aerie Pharmaceuticals, headquartered in Bedminster, New Jersey, USA, is the pioneering developer and marketer of netarsudil mesylate. The company developed Rhopressa and Roclanda (fixed-dose combination with latanoprost), obtaining FDA approval in 2017 and 2019, respectively. As the patent holder, Aerie maintains manufacturing operations that supply netarsudil mesylate directly or through authorized third-party contract manufacturers.

Manufacturing Capabilities:

Owns dedicated facilities optimized for sterile ophthalmic drug production.
Implements Good Manufacturing Practices (GMP) aligned with FDA standards.
Engages with strategic contract manufacturing organizations (CMOs) for scale-up and global distribution.

Global Reach:
While Aerie primarily supplies within North America, it partners with international distributors and engages in licensing agreements to facilitate entry into European and Asian markets.

2. Contract Manufacturing Organizations (CMOs)

As a relatively new molecule in the ophthalmic market, many pharmaceutical developers rely on CMOs to produce netarsudil mesylate at scale. Several active CMOs are involved:

Boehringer Ingelheim
A leading global CMO specializing in complex chemical synthesis and sterile injectables, Boehringer Ingelheim potentially offers cGMP-compliant production for netarsudil mesylate intermediates and finished dosage forms.
Siegfried AG
Based in Switzerland, Siegfried specializes in high-quality custom synthesis, contract manufacturing, and biosimilars, with capabilities for active pharmaceutical ingredient (API) production.
Catalent Pharma Solutions
A prominent global provider in drug development, manufacturing, and packaging, Catalent supports ophthalmic drug manufacturing and could be contracted for netarsudil mesylate formulations.

Key Considerations:

The choice of CMO depends on capacity, compliance, and geographical distribution.
CMOs like Siegfried and Boehringer form part of the supply chain, often under confidential long-term agreements with innovators like Aerie.

Chemical Intermediates and Raw Material Suppliers

The production of netarsudil mesylate begins with complex chemical synthesis involving multiple intermediates. Reliable suppliers are crucial for lab-scale, clinical, and commercial manufacturing.

1. Chemical Raw Material Suppliers

Sigma-Aldrich (Merck KGaA)
Supplies high-purity raw chemicals such as specific heterocyclic compounds, reagents, and solvents used in netarsudil synthesis.
Thermo Fisher Scientific
Provides specialized chemicals, including chiral intermediates, necessary for complex synthesis routes.
Alfa Aesar (a Johnson Matthey company)
Offers a broad portfolio of research-grade and commercial-grade chemicals employed during the synthesis process.

2. API Synthesis Intermediates

Aladdin Chemistry
Focuses on custom synthesis, providing specific intermediates required in netarsudil preparation.
FudaChem
An emerging supplier in Asia, FudaChem offers cost-effective synthesis intermediates suited for large-scale production, with quality certifications suitable for pharmaceutical use.

Market Dynamics:
The procurement of intermediates is typically managed via strategic sourcing, considering factors such as purity levels, manufacturing licenses, and proximity to manufacturing facilities.

Regulatory and Licensing Aspects

Suppliers must adhere to stringent regulatory standards to market in major jurisdictions like the United States, Europe, and Asia.

FDA Compliance:
US-based manufacturers must maintain cGMP standards. Aerie Pharmaceuticals holds multiple FDA approvals, implicitly validating their manufacturing partners' compliance.
EMA Regulations:
European suppliers engaged in global distribution align with EMA standards, requiring rigorous validation and batch certification.
Additional Certifications:
Suppliers often hold certifications such as ISO 9001, ISO 13485 (for medical devices), and ICH Q7 (for active pharmaceutical ingredient manufacturing).

Emerging Market Suppliers and Regional Players

In recent years, regional pharmaceutical producers, especially in China and India, have begun developing capabilities for complex ophthalmic APIs. These suppliers are characterized by:

Cost advantages for generics or biosimilar development.
Rapid scalability to meet global demand.
Potential for strategic partnerships with multinational pharma companies.

Examples include:

Hengyang Chem-Pharm (China)
Sun Pharmaceutical Industries Ltd. (India)

Their involvement remains primarily in early-stage manufacturing, pending regulatory approvals.

Distribution Channels and Logistics

Effective distribution relies on validated logistics providers with cold chain expertise:

DHL Life Sciences & Healthcare
FedEx Custom Critical
UPS Healthcare Logistics

These entities ensure the integrity of netarsudil mesylate during international shipping, adhering to preservation requirements specified by manufacturers.

Strategic Insights for Stakeholders

Manufacturers and Distributors:
Should prioritize partnerships with GMP-compliant CMOs with proven track records in ophthalmic APIs.
Investors:
Must scrutinize licensing agreements with key patent holders and assess the capacity expansion plans of established suppliers.
Developers and Innovators:
Seek diversified supplier networks to mitigate risks associated with supply chain disruptions.

Key Takeaways

Primary Supplier: Aerie Pharmaceuticals remains the original developer and core supplier of netarsudil mesylate, with manufacturing primarily based in the USA and partnerships globally.
Contract Manufacturers: Several CMOs, including Boehringer Ingelheim and Siegfried AG, provide manufacturing capacity, highlighting the importance of strategic alliances for scale-up.
Raw Material Sources: Leading chemical suppliers such as Sigma-Aldrich and Thermo Fisher support synthesis with high-purity reagents and intermediates.
Regulatory Compliance: Suppliers must maintain adherence to GMP, ISO, and other regulatory standards to ensure quality and market access.
Emerging Markets: Regional suppliers in China and India are poised to increase their share, driven by cost advantages and local manufacturing incentives.

FAQs

1. Who are the main pharmaceutical suppliers of netarsudil mesylate?
Aerie Pharmaceuticals is the primary developer and initial supplier of netarsudil mesylate. It depends on contract manufacturing organizations (CMOs) such as Boehringer Ingelheim and Siegfried AG for large-scale production.

2. Are there generic suppliers for netarsudil mesylate?
As of now, no approved generic versions exist, owing to patent exclusivity held by Aerie Pharmaceuticals. However, regional players may develop biosimilar or generic formulations post patent expiration.

3. What qualities should I look for in a netarsudil mesylate supplier?
Key factors include GMP compliance, regulatory certifications, proven manufacturing capacity, quality control protocols, and geographical logistics capabilities.

4. Can raw material sourcing impact the quality of netarsudil mesylate?
Yes, sourcing high-purity, certified chemicals from reputable suppliers ensures consistent API quality and compliance with regulatory standards.

5. How are suppliers in emerging markets impacting the supply chain for netarsudil mesylate?
Emerging market suppliers contribute to cost reduction and increased capacity, but their inclusion requires careful regulatory verification and quality assurance to meet international standards.

References

[1] U.S. Food and Drug Administration. (2019). Rhopressa (netarsudil ophthalmic solution).
[2] Aerie Pharmaceuticals. (2022). Corporate Website.
[3] EMA. (2020). Regulatory standards for ophthalmic pharmaceuticals.
[4] Sigma-Aldrich. (2022). Chemical and reagent supplies.
[5] Siegfried AG. (2022). Contract manufacturing services.

Suppliers and packagers for generic pharmaceutical drug: NETARSUDIL MESYLATE