Suppliers and packagers for rocklatan

rocklatan

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	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259	NDA	Alcon Laboratories, Inc.	70727-529-25	1 BOTTLE, PLASTIC in 1 CARTON (70727-529-25) / 2.5 mL in 1 BOTTLE, PLASTIC	2019-03-12
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259	NDA	Alcon Laboratories, Inc.	70727-529-99	1 BOTTLE, PLASTIC in 1 CARTON (70727-529-99) / 2.5 mL in 1 BOTTLE, PLASTIC	2019-03-12

Suppliers for the Pharmaceutical Drug: ROCKLATAN

Last updated: July 30, 2025

Introduction

ROCKLATAN (netarsudil ophthalmic solution) is a prescribed medication primarily used to lower intraocular pressure in glaucoma and ocular hypertension. Since its approval by the U.S. Food and Drug Administration (FDA) in 2017, ROCKLATAN has become an essential treatment option for ophthalmologists. Its active ingredient, netarsudil, is a Rho kinase (ROCK) inhibitor that enhances aqueous humor outflow and decreases intraocular pressure. Given the critical role it plays in glaucoma management, understanding its supply chain, including key suppliers, is vital for stakeholders across healthcare, pharmacy, and pharmaceutical manufacturing sectors.

Manufacturers of ROCKLATAN

The sole manufacturing entity responsible for ROCKLATAN is Aerie Pharmaceuticals, Inc., based in California, USA. As the innovator company, Aerie developed, tested, and obtained regulatory approval for ROCKLATAN, and it maintains exclusive rights to manufacture and distribute the drug. The company's integration of research, manufacturing, and distribution processes ensures control over supply; however, external suppliers for raw materials and excipients underpin its production capacity.

Raw Material Suppliers

The production of ROCKLATAN hinges on several critical raw materials, including active pharmaceutical ingredient (API) netarsudil, as well as excipients such as preservatives, stabilizers, and solvents. Ensuring a robust, high-quality supply of these components is essential for consistent manufacturing.

1. Active Pharmaceutical Ingredient (API): Netarsudil

   • Manufacturing and Sourcing: Aerie Pharmaceuticals synthesizes netarsudil in-house, leveraging proprietary processes that include complex chemical syntheses requiring specialized raw materials. Although Aerie produces the API internally, it may source key intermediates or catalysts from trusted suppliers globally. The chemical synthesis involves intermediates that are typically supplied by specialty chemical companies based in Europe, Asia, or North America.

   • Major API Suppliers: Currently, detailed public disclosures about specific API raw material suppliers are limited due to confidentiality agreements common in pharmaceutical manufacturing. However, a review of industry practices suggests reliance on well-established chemical intermediates suppliers who meet Good Manufacturing Practice (GMP) standards. Major chemical suppliers include companies such as Cambridge Isotope Laboratories, BASF, and Sigma-Aldrich (a subsidiary of Merck), which supply high-purity chemical intermediates and reagents necessary for API synthesis.

2. Excipient Suppliers

   • Preservatives and Stabilizers: The ophthalmic formulation includes preservatives like benzalkonium chloride, supplied by operators such as Tosoh Corporation or Clariant.
   • Solvents: The formulation employs solvents like sterile water for injection, supplied by large-scale pharmaceutical water manufacturers such as Pall Corporation or Kewpie Corporation.

Distribution and Supply Chain Dynamics

While Aerie Pharmaceuticals handles the primary manufacturing, the supply chain for ROCKLATAN extends to a global network of raw material suppliers and contract manufacturing organizations (CMOs). These entities ensure the uninterrupted supply of raw components, the production of finished drug products, and their distribution to markets worldwide.

• Global Sourcing: Aerie's procurement strategy involves sourcing raw materials from multiple regions to mitigate supply disruptions. Asia-Pacific remains a significant site for chemical intermediates, especially from China and India, where many suppliers adhere to GMP standards.

• Manufacturing Facilities: Aerie maintains manufacturing facilities in the United States, with some components produced through CMOs or third-party vendors, ensuring scalability to meet global demand.

Regulatory and Supply Chain Risks

The pharmaceutical supply chain for ROCKLATAN faces several vulnerabilities:

• Raw Material Disruptions: Shortages of chemical intermediates or excipients due to geopolitical issues, trade restrictions, or manufacturing delays can impair production.
• Regulatory Compliance: Suppliers must adhere to rigorous GMP regulations. Failure to comply can result in supply revocations or product recalls.
• Capacity Constraints: As demand for ROCKLATAN grows, especially in emerging markets, capacity limitations at manufacturing or raw material sourcing stages may lead to shortages.

Emerging Trends and Industry Responses

• Supplier Diversification: Aerie likely diversifies its raw material sources to avoid over-reliance on single suppliers or regions.
• Long-term Supply Agreements: To secure consistent supply, Aerie might engage in bilateral contracts with key suppliers, leveraging quality assurances and capacity commitments.
• Vertical Integration: While currently reliant on external suppliers for some raw materials, Aerie's focus remains on in-house synthesis of API, diminishing dependency over time.

Future Outlook

The landscape for ROCKLATAN suppliers is poised for evolution as generics and biosimilars enter the market or as new ROCK inhibitors are developed. Additionally, ongoing efforts toward localizing supply chains and adopting sustainable manufacturing practices could influence supplier selection and procurement strategies.

Key Takeaways

• Aerie Pharmaceuticals is the exclusive manufacturer of ROCKLATAN, sourcing raw materials from a network of specialized chemical suppliers.
• High-quality, GMP-compliant raw materials and excipients are critical for ensuring drug efficacy and safety.
• The supply chain faces risks like geopolitical disruptions, capacity limitations, and regulatory compliance challenges.
• Supplier diversification and long-term agreements are vital strategies for supply stability.
• Industry trends favor vertical integration, geographic diversification, and sustainability-focused procurement.

FAQs

1. Who are the primary suppliers of the API netarsudil used in ROCKLATAN?
Aerie Pharmaceuticals synthesizes netarsudil internally, but it sources key chemical intermediates from specialty chemical companies worldwide, including suppliers of GMP-grade reagents from North America, Europe, and Asia.

2. Are there alternative suppliers for ROCKLATAN’s excipients?
Yes. Excipients such as preservatives and solvents are supplied by multinational chemical companies like Tosoh Corporation and Pall Corporation. The supply chain is diversified to mitigate risk.

3. Is there a risk of drug shortages due to raw material supply disruptions?
While the supply chain is well-managed, geopolitical issues, manufacturing delays, or shortages of critical intermediates could pose risks, emphasizing the importance of supplier diversification and contingency planning.

4. Will new manufacturers enter the ROCKLATAN supply chain?
Potentially. As demand grows and patent exclusivity persists, other manufacturers may seek to produce biosimilar or generic versions, which could alter the existing supply landscape.

5. How does Aerie Pharmaceuticals ensure the quality of its raw materials?
Aerie maintains strict supplier qualification processes, audits, and relies on GMP-certified suppliers to secure high-quality raw materials, ensuring safety and efficacy for ROCKLATAN.

---

Sources

[1] U.S. Food and Drug Administration (FDA). "ROCKLATAN (netarsudil ophthalmic solution) Approval." 2017.
[2] Aerie Pharmaceuticals. "Product Pipeline and Manufacturing." 2023.
[3] Chemical Supplier Websites (e.g., BASF, Sigma-Aldrich).
[4] Industry Reports on Pharmaceutical API Manufacturing and Supply Chains (e.g., IQVIA, Evaluate Pharma).
[5] Public Disclosures and Patent Filings by Aerie Pharmaceuticals.