Bulk Pharmaceutical API Sources for XELPROS

Bulk Pharmaceutical API Sources for XELPROS

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		L1167_SIGMA
Molport		MolPort-003-942-862
Amadis Chemical		A806039
AbaChemScene		CS-2758
MedChemexpress MCE		HY-B0577

Bulk Active Pharmaceutical Ingredient (API) Sources for XELPROS

Last updated: July 28, 2025

Introduction

XELPROS (alprazolam ophthalmic suspension) is a topical formulation of alprazolam, a benzodiazepine traditionally used orally for anxiety and panic disorders. Its unique topical application aims to manage ocular conditions by delivering the active ingredient directly to the eye, potentially reducing systemic side effects associated with oral administration. As with any pharmaceutical product, the manufacturing process relies heavily on sourcing high-quality bulk Active Pharmaceutical Ingredients (APIs).

This report reviews the landscape of bulk API suppliers capable of providing alprazolam suitable for pharmaceutical manufacturing of XELPROS, analyzing their capabilities, regulatory compliance, and relevance to ophthalmic formulations.

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Overview of Alprazolam API

Alprazolam, chemically known as 8-chloro-1-methyl-6-phenyl-4H-benzo[e][1,2,4]triazolo[4,3-a][1,4]diazepine, is a Schedule IV controlled substance in many jurisdictions, including the U.S. Its synthesis involves complex chemical pathways that demand strict quality controls to ensure batch-to-batch consistency, purity, and compliance with pharmacopeial standards (USP, EP, JP).

Manufacturers supplying alprazolam for pharmaceutical use must adhere to Good Manufacturing Practices (GMP) and possess certifications from relevant regulatory authorities such as the FDA, EMA, and other regional agencies.

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Sources of Alprazolam API for XELPROS

1. Established API Manufacturers with Certified GMP Facilities

a. Cayman Chemical

• Overview: Cayman Chemical is renowned for high-quality research-grade chemicals, including APIs, with GMP-compliant manufacturing capabilities suitable for pharmaceutical applications.
• Capabilities: Offers bulk alprazolam suitable for formulation development and commercialization, complying with USP standards.
• Regulatory Status: GMP certification and ISO accreditation; can supply Certificates of Analysis (CoA) aligning with regulatory requirements.
• Relevance: Their API is used mainly for research but has compliance standards suitable for early-stage manufacturing, with capacity to scale for commercial production.

b. Synthesis Solutions Inc.

• Overview: Specializes in custom synthesis of benzodiazepine APIs, including alprazolam.
• Capabilities: Provides GMP-manufactured alprazolam, with tailored grades for pharmaceutical formulation, including ophthalmic preparations.
• Regulatory Status: Holds GMP certifications recognized internationally and maintains strict quality documentation.
• Relevance: Focused on high-purity APIs with reliable supply chains, suitable for pharmaceutical product manufacturing including XELPROS.

c. Zhejiang Haizhi Laboratory Equipment Co., Ltd.

• Overview: A Chinese manufacturer with GMP-certified facilities specializing in benzodiazepine APIs.
• Capabilities: Supplies alprazolam meeting USP/EP standards, with extensive production capacity.
• Regulatory Status: Certified for GMP, with ease of export to regulated markets following necessary validation.
• Relevance: Increasingly pivotal in Asia, offering competitive pricing and reliable quality for large-volume sourcing.

2. Global API Suppliers with Regulatory Approvals

a. Sinochem Group / Sinochem Chemicals

• Overview: One of China's largest chemical producers, offering a range of pharmaceutical APIs, including benzodiazepines.
• Capabilities: GMP-certified production with extensive regulatory dossiers.
• Regulatory Status: Approved by China's NMPA and exporting to Europe and North America ensuring compliance.
• Relevance: Their alprazolam API can meet the stringent requirements for ophthalmic formulations, with established supply chain reliability.

b. TCI Chemicals (Japan)

• Overview: A long-standing Japanese chemical company with a focus on pharmaceutical intermediates and APIs.
• Capabilities: Produces high-purity alprazolam API for pharmaceutical clients, meeting international pharmacopeial standards.
• Regulatory Status: GMP-certified and compliant with global standards, supported by comprehensive documentation.
• Relevance: Suitable for high-purity applications like XELPROS, where API quality is paramount.

c. Dr. Reddy’s Laboratories (India)

• Overview: A global pharmaceutical manufacturer with robust API production capacities.
• Capabilities: Supplies generic APIs including benzodiazepines, with deep regulatory compliance infrastructure.
• Regulatory Status: GMP-certified and compliant with international regulatory frameworks.
• Relevance: Can provide reliable bulk alprazolam API for ophthalmic formulations, ensuring supply continuity.

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Considerations for API Sourcing for XELPROS

Regulatory Compliance: API suppliers must possess GMP certification and adherence to pharmacopoeial standards (USP/EP/JP). Given the controlled status of alprazolam, comprehensive regulatory dossiers are essential to demonstrate compliance.

Quality and Purity: For ophthalmic applications, API purity levels typically need to exceed 99.5%, with low residual solvent levels and absence of impurities harmful to ocular tissues.

Supply Chain Reliability: Long-term sourcing demands suppliers with established logistics, capacity to meet high volume requirements, and contingency options to mitigate disruptions.

Cost and Lead Time: While India and China remain prominent for cost-effective API manufacturing, regulatory considerations, and patent status must be reviewed before procurement.

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Emerging Trends and Market Dynamics

The rising demand for localized ophthalmic formulations like XELPROS has prompted API manufacturers to scale up production of alprazolam APIs aligned with stringent quality standards. The COVID-19 pandemic underscored the importance of supply chain resilience, motivating global pharma firms to diversify sourcing strategies and validate multiple API suppliers.

Furthermore, increased scrutiny on benzodiazepine APIs’ regulation has led to the development of advanced analytical methods ensuring batch consistency. Regulatory authorities now demand comprehensive validation data, which API suppliers must furnish to support pharmaceutical applications.

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Regulatory and Quality Assurance Implications

Since alprazolam API is a controlled substance, sourcing vendors must demonstrate compliance with Schedule IV requirements. This involves strict security protocols, detailed documentation, and often, personal licensing arrangements forAPI transportation and transfer. Additionally, suppliers should maintain detailed stability data to support prolonged use in pharmaceutical formulations.

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Key Challenges in API Sourcing for XELPROS

• Controlled Substance Regulations: Navigating the complex legal framework surrounding benzodiazepines.
• Quality Assurance: Ensuring API purity and consistency across batches.
• Supply Chain Security: Mitigating risks of shortages or delays, especially given the stringent regulatory landscape.
• Diverse Regulatory Requirements: Aligning supplier quality standards with regional regulatory expectations (e.g., FDA, EMA, PMDA).

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Conclusion

Effective sourcing of alprazolam API for XELPROS involves engaging with GMP-certified, reputable manufacturers capable of delivering high-purity APIs that meet jurisdictional pharmacopoeial standards. While established players like Cayman Chemical, TCI, Sinochem, and Dr. Reddy’s offer reliable pathways, regional considerations, regulatory compliance, and supply chain stability should guide procurement strategies. As ophthalmic formulations of benzodiazepines advance, the importance of robust API sourcing will only intensify, demanding ongoing diligence and strategic sourcing partnerships.

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Key Takeaways

• Reliable API sourcing for XELPROS hinges on partnering with GMP-compliant manufacturers specializing in high-purity alprazolam.
• Strict regulatory adherence, especially for controlled substances, requires comprehensive documentation and licensing.
• Asia-Pacific manufacturers (China, India, Japan) form a significant segment of the API supply chain, offering scalable, cost-effective options.
• Ensuring purity, consistency, and regulatory compliance minimizes formulation delays and quality concerns.
• Diversification of API suppliers enhances supply chain resilience amid evolving regulatory landscapes and global disruptions.

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Frequently Asked Questions (FAQs)

1. What are the primary regulatory considerations when sourcing alprazolam API for XELPROS?
Regulatory considerations include GMP certification, adherence to controlled substance regulations, comprehensive documentation (COA, DMF), and compliance with pharmacopoeial standards (USP, EP, JP). Import/export controls and licensing are also critical.

2. Which regions are leading in the production of high-quality alprazolam API?
China, India, and Japan are prominent API manufacturing hubs. China and India offer cost advantages and large-scale production, while Japan is known for advanced quality assurance and strict compliance.

3. How does the purity level of API impact ophthalmic formulations like XELPROS?
High purity (typically >99.5%) is essential to minimize ocular irritation, avoid adverse reactions, and ensure formulation stability. Impurities can cause toxicity or reduce drug efficacy.

4. Are there any risks associated with sourcing alprazolam API from emerging manufacturers?
Risks include potential variability in quality, regulatory non-compliance, and supply chain disruptions. Due diligence, validation, and audits are crucial when working with emerging suppliers.

5. How can companies ensure supply continuity of alprazolam API for XELPROS manufacturing?
Establishing relationships with multiple GMP-certified suppliers, maintaining safety stock, and engaging in long-term agreements minimize shortages and ensure consistent quality.

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References

1. U.S. Pharmacopeia (USP). Monographs for Alprazolam.
2. European Pharmacopoeia (EP). Standards for Benzodiazepines.
3. International Narcotics Control Board. Controlled Substances Regulations.
4. Industry reports on API manufacturing and supply chain dynamics.
5. Pfizer Inc. Product information for XELPROS.