Suppliers and packagers for XELPROS

XELPROS

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

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

XELPROS (latanoprost ophthalmic solution) Supply Chain Analysis

Last updated: February 19, 2026

XELPROS, a prostaglandin analog used to treat open-angle glaucoma and ocular hypertension, relies on a specialized supply chain for its active pharmaceutical ingredient (API) and finished drug product. This analysis details key suppliers and manufacturing processes critical to XELPROS production.

What is the API for XELPROS?

The active pharmaceutical ingredient in XELPROS is latanoprost. Latanoprost is a prostanoic acid derivative that increases intraocular pressure (IOP) by increasing the outflow of aqueous humor. The synthesis of latanoprost is a complex multi-step process requiring specialized chemical manufacturing capabilities.

Who Manufactures Latanoprost API?

The production of latanoprost API is concentrated among a limited number of specialized chemical manufacturers globally. These companies possess the expertise in chiral synthesis and the infrastructure to handle the specific chemical reactions and purification steps involved.

Key manufacturers and their approximate market share or identified capabilities include:

• Thermo Fisher Scientific (Patheon): A major contract development and manufacturing organization (CDMO) with a significant presence in API production. Patheon has been identified as a supplier for latanoprost. [1] Their facilities are equipped for complex organic synthesis.
• Wuxi AppTec: Another prominent global CDMO that offers comprehensive API development and manufacturing services. Wuxi AppTec has the capacity to produce complex APIs like latanoprost.
• Specific Chemical Synthesis Companies: While not always publicly disclosed for proprietary reasons, several specialized chemical synthesis firms in Europe and Asia are known to produce prostaglandin intermediates and APIs. These may include companies with expertise in steroid chemistry and chiral resolution.

The precise identity of all API suppliers for XELPROS is proprietary information held by the drug's marketer. However, the landscape for prostaglandin analog APIs is generally dominated by a few key players due to the specialized nature of the chemistry.

What are the Key Manufacturing Steps for Latanoprost API?

The synthesis of latanoprost involves a series of intricate chemical transformations. While specific routes are proprietary, common steps in prostaglandin synthesis include:

1. Core Structure Synthesis: Building the fundamental carbon skeleton of the prostaglandin molecule, often starting from readily available precursors.
2. Chiral Synthesis/Resolution: Introducing specific stereocenters to achieve the desired biologically active isomer. This often involves asymmetric synthesis or the separation of racemic mixtures.
3. Functional Group Manipulation: Adding and modifying hydroxyl, carboxyl, and other functional groups at precise positions on the molecule.
4. Esterification: Forming the isopropyl ester moiety, which is characteristic of latanoprost.
5. Purification: Rigorous purification steps, including chromatography and crystallization, are essential to achieve the high purity required for pharmaceutical use.

The synthesis demands strict control over reaction conditions, temperature, pressure, and reagent stoichiometry to ensure yield and purity. Quality control checkpoints are embedded throughout the process.

Who Manufactures XELPROS Finished Drug Product?

XELPROS is an ophthalmic solution. The formulation of eye drops requires specialized sterile manufacturing facilities and aseptic processing techniques. The marketer of XELPROS, currently Sun Pharmaceutical Industries, outsources the finished drug product manufacturing to contract manufacturing organizations (CMOs) with this specific expertise.

Identified CMOs involved in the production of XELPROS or similar ophthalmic formulations include:

• Catalent Pharma Solutions: A leading global provider of drug manufacturing and development services. Catalent operates sterile manufacturing facilities capable of producing ophthalmic solutions. They are known to manufacture for numerous pharmaceutical companies, including for Sun Pharma. [2]
• PCI Synthesis: Engaged in the development and manufacturing of sterile liquid and semi-solid dosage forms. PCI Synthesis has the capabilities for aseptic filling of ophthalmic products.
• Other Specialized Ophthalmic CMOs: The market for sterile ophthalmic manufacturing includes several niche players with dedicated cleanroom facilities and expertise in eye drop formulation and filling.

The selection of a CMO is based on adherence to Current Good Manufacturing Practices (cGMP), regulatory compliance (FDA, EMA), sterile fill-finish capabilities, and the ability to handle the specific viscosity and stability requirements of XELPROS.

What are the Key Components of the XELPROS Formulation?

Beyond the API (latanoprost), XELPROS is an ophthalmic solution that contains several excipients to ensure stability, solubility, and patient comfort. These include:

• Solvents: Typically purified water for injection.
• Buffering Agents: To maintain a specific pH for ocular comfort and drug stability (e.g., sodium phosphate, monobasic; disodium phosphate, dibasic).
• Tonicity Agents: To adjust the osmotic pressure of the solution to be isotonic with tears (e.g., sodium chloride).
• Preservatives: To prevent microbial contamination in multi-dose containers (e.g., benzalkonium chloride). The use and concentration of preservatives are critical for ophthalmic products.
• Solubilizers/Emulsifiers: Though less common in simple solutions, these might be used if solubility is a challenge.

The sourcing of these excipients is also a critical aspect of the supply chain. Pharmaceutical-grade excipients must meet stringent purity standards and come from qualified suppliers with robust quality management systems.

What are the Regulatory Requirements for XELPROS Manufacturing?

The manufacturing of XELPROS, from API synthesis to finished product, is subject to stringent regulatory oversight by health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Key requirements include:

• Current Good Manufacturing Practices (cGMP): All manufacturing facilities must adhere to cGMP regulations, which govern quality control, facility design, equipment validation, personnel training, and documentation.
• Drug Master Files (DMFs): API manufacturers typically maintain DMFs that contain detailed information about the manufacturing process, quality control, and stability of the API. These DMFs are referenced in the drug application of the finished product marketer.
• Process Validation: Manufacturing processes for both API and finished product must be validated to demonstrate consistency and reproducibility.
• Sterile Manufacturing Standards: Ophthalmic products require adherence to specialized sterile manufacturing standards, including aseptic processing and environmental monitoring of cleanrooms.
• Supply Chain Security: Measures to ensure the integrity and traceability of raw materials and finished products throughout the supply chain are essential to prevent counterfeiting and diversion.

Compliance with these regulations is audited regularly by regulatory agencies. Any deviations can lead to product recalls, import alerts, or manufacturing suspensions.

How is the XELPROS Supply Chain Managed?

The management of the XELPROS supply chain involves several critical functions:

• Supplier Qualification and Auditing: Rigorous selection and ongoing auditing of API manufacturers, excipient suppliers, and CMOs to ensure quality and compliance.
• Inventory Management: Maintaining adequate stock levels of API, intermediates, and finished product to meet market demand while minimizing obsolescence and holding costs.
• Logistics and Distribution: Managing the secure and timely transportation of materials and finished goods from manufacturing sites to distribution centers and ultimately to pharmacies. Cold chain management may be required depending on product stability.
• Quality Assurance and Control: Implementing comprehensive quality systems at all stages of the supply chain to monitor and ensure product quality and safety.
• Regulatory Affairs: Ensuring all aspects of the supply chain comply with relevant pharmaceutical regulations in all markets where XELPROS is sold.

Given the specialized nature of ophthalmic drugs and prostaglandin synthesis, supply chain disruptions can have significant impacts. Dual sourcing strategies for critical components are often employed to mitigate these risks.

Key Takeaways

• XELPROS's active pharmaceutical ingredient is latanoprost, a complex prostaglandin synthesized by specialized chemical manufacturers.
• Finished drug product manufacturing for XELPROS ophthalmic solution is conducted by contract manufacturing organizations with sterile fill-finish capabilities.
• Key suppliers include global CDMOs and CMOs like Thermo Fisher Scientific (Patheon) and Catalent Pharma Solutions, alongside specialized chemical synthesis firms.
• The supply chain is governed by strict regulatory requirements, including cGMP, and relies on robust quality assurance and supplier qualification processes.
• Management focuses on supplier qualification, inventory control, secure logistics, and ensuring end-to-end compliance.

Frequently Asked Questions

What is the typical lead time for sourcing latanoprost API?

The typical lead time for sourcing complex APIs like latanoprost can range from 6 to 12 months, depending on the manufacturer's existing capacity, batch size, and production schedule.

How does Sun Pharma ensure the quality of its XELPROS supply chain partners?

Sun Pharma employs a rigorous supplier qualification program that includes site audits, review of quality systems, analytical testing of materials, and ongoing performance monitoring to ensure adherence to cGMP and product specifications.

Are there alternative suppliers for latanoprost API if a primary supplier faces disruption?

The pharmaceutical industry often seeks to qualify secondary or tertiary suppliers for critical APIs to mitigate supply chain risks. The process of qualifying a new API supplier can take 18-24 months.

What are the primary risks associated with the XELPROS supply chain?

Primary risks include API manufacturing capacity constraints, geopolitical instability affecting raw material sourcing, regulatory changes impacting manufacturing sites, and potential quality deviations from any supply chain partner.

Can generic manufacturers easily replicate the XELPROS supply chain upon patent expiry?

While the chemical synthesis of latanoprost can be replicated with sufficient expertise, establishing the same level of quality, regulatory compliance, and cost-efficiency in the supply chain, particularly for sterile ophthalmic manufacturing, requires significant investment and time.

Citations

[1] Thermo Fisher Scientific. (n.d.). APIs and Small Molecules. Retrieved from https://www.thermofisher.com/us/en/home/products-and-services/manufacturing/api-and-small-molecule-manufacturing.html [2] Catalent Pharma Solutions. (n.d.). Ophthalmic Solutions. Retrieved from https://www.catalent.com/capabilities/drug-manufacturing/ophthalmic-solutions/