Bulk Pharmaceutical API Sources for PROLENSA

Bulk Pharmaceutical API Sources for PROLENSA

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS016008745
Molport		MolPort-027-948-611
AvaChem Scientific		91714-93-1
AvaChem Scientific		2601

Bulk Active Pharmaceutical Ingredient (API) Sources for: PROLENSA (TELEPERSEPT)

Last updated: July 28, 2025

Introduction
Prolensa, marketed as TELEPERSEPT in some regions, is a non-steroidal anti-inflammatory drug (NSAID) primarily containing bromfenac sodium as its active ingredient. As an ophthalmic solution for pain and inflammation associated with ocular surgery, ensuring a reliable supply of its active pharmaceutical ingredient (API), bromfenac sodium, is crucial for manufacturers, health authorities, and stakeholders throughout the supply chain. This article offers a comprehensive analysis of bulk API sources for bromfenac sodium, examining key manufacturers, geographic considerations, regulatory factors, and supply chain dynamics essential for strategic procurement and risk management.

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1. Overview of Bromfenac Sodium as API for PROLENSA

Bromfenac sodium is a brominated NSAID with high potency and stability suitable for ophthalmic formulations. It functions by inhibiting cyclooxygenase enzymes involved in prostaglandin synthesis, thereby reducing ocular inflammation and pain. The manufacturing complexity of bromfenac sodium involves multi-step chemical synthesis, requiring high-quality controls to meet pharmacopeial standards (e.g., USP, EP).

The demand for bromfenac sodium API is driven by the ophthalmic segment, with growth propelled by aging populations, increasing prevalence of ocular surgeries, and expanding indications for NSAID eye drops. Ensuring a diversified supply base mitigates risks related to production disruptions, regulatory hurdles, or geopolitical uncertainties.

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2. Leading API Manufacturers for Bromfenac Sodium

The global API landscape includes several prominent producers specializing in NSAID APIs, including bromfenac sodium. The most notable sources are concentrated in Asia, particularly India, China, and South Korea, with some players in Europe and North America. Key manufacturers include:

a. BOS Chemicals (India)

BOS Chemicals offers comprehensive API manufacturing, including bromfenac sodium, targeting global markets. Their state-of-the-art facilities adhere to GMP standards, and they possess a robust export record to North America, Europe, and Asia. They emphasize product quality, regulatory compliance, and supply reliability.

b. Hunan Lijun Pharmaceutical Co., Ltd. (China)

This Chinese manufacturer supplies high-purity bromfenac sodium API with competitive pricing. Their manufacturing process is optimized for large-scale production, supported by strong R&D capabilities for custom synthesis. They have achieved API certifications aligned with international standards (e.g., ISO, GMP).

c. Hanmi Pharmaceutical (South Korea)

Hanmi specializes in ophthalmic APIs, including bromfenac derivatives. Their facilities in Korea are certified by the Korean Ministry of Food and Drug Safety (MFDS) and hold international certifications like cGMP, facilitating exports globally.

d. Siegfried AG (Switzerland)

While primarily a specialty chemical company, Siegfried offers APIs for select NSAIDs, including bromfenac sodium, with high-quality standards suitable for ophthalmic formulations. Their strategic partnerships with major pharmaceutical firms enhance their market penetration for niche APIs.

e. Other Notable Asian Suppliers

• Jiangsu Hengrui Medicine Co., Ltd. (China): Focused on high-value APIs for oncological and ophthalmic indications, with premium quality standards.
• Alfa Aesar (a division of Thermo Fisher Scientific): Distributes pharmaceutical-grade bromfenac sodium API sourced from certified manufacturers globally.

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3. Geographic and Regulatory Considerations

The API sourcing strategy should account for geographic and regulatory factors influencing supply security:

• India and China Domination: The majority of affordable bromfenac sodium APIs originate here, benefitting from extensive manufacturing infrastructure but facing geopolitical considerations and varying regulatory compliance standards.

• European and North American Suppliers: Limited but high-quality European and American API producers emphasize stricter regulatory oversight (e.g., EMA, FDA) ensuring compliance but often at higher costs.

• Regulatory Approvals and Certifications: Suppliers with cGMP certification, ISO standards, and compliance with the United States Pharmacopeia (USP) or European Pharmacopoeia (EP) foster confidence in quality and facilitate regulatory registration.

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4. Supply Chain Dynamics and Risks

In sourcing bromfenac sodium API at scale, stakeholders must navigate several risks:

• Supply Disruptions: Dependence on regional hubs (e.g., Chinese API manufacturers) exposes supply chains to geopolitical tensions, export restrictions, or pandemic-related disruptions.

• Quality Variability: Ensuring consistent quality requires rigorous qualification processes, audits, and supplier validation.

• Price Volatility: Commodity prices for raw chemicals fluctuate with global market conditions; strategic inventory management buffers against sudden price spikes.

• Regulatory Barriers: Navigating complex import/export regulations and achieving approval in target markets require tailored compliance strategies with each supplier.

To mitigate these risks, a diversified supplier base, robust supplier qualification programs, and strategic stockpiling are essential.

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5. Strategic Sourcing and Partnership Recommendations

• Multi-Source Strategy: Engage multiple qualified API suppliers spanning different regions to ensure supply continuity and negotiate favorable terms.

• Supplier Qualification: Prioritize suppliers holding GMP, ISO certifications, and comprehensive quality documentation.

• Long-term Agreements: Formalize supply commitments through contracts to lock in pricing, ensure priority during shortages, and facilitate technical support.

• Collaborative R&D: Work with suppliers on process improvements and custom synthesis to enhance yield, purity, and cost-effectiveness.

• Monitoring and Compliance: Regularly review supplier regulatory standing, production capacity, and geopolitical developments impacting supply.

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6. Future Outlook and Market Trends

The demand for bromfenac sodium API is expected to grow paralleling ophthalmic surgical volumes and emerging indications. Innovation in synthetic routes may introduce new suppliers or improve existing processes. Regulatory harmonization efforts could streamline cross-border approvals, enhancing supply resilience. Additionally, regional API manufacturing hubs are likely to expand capacity to reduce dependence on traditional centers like China and India.

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Key Takeaways

• The primary bulk API sources for PROLENSA (bromfenac sodium) are predominantly based in India, China, and South Korea, with European and North American suppliers offering high-quality alternatives.
• Ensuring supply security requires a diversified sourcing strategy, emphasizing suppliers with GMP and international certifications.
• Geopolitical and regulatory factors significantly influence API sourcing, demanding ongoing monitoring and risk mitigation strategies.
• Strategic partnerships, long-term agreements, and quality audits underpin resilient API procurement for ophthalmic formulations like PROLENSA.
• Future supply chain stability hinges on expanding regional manufacturing, process innovation, and regulatory harmonization.

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FAQs

Q1: What factors should I consider when selecting an API supplier for bromfenac sodium?
A1: Key factors include regulatory compliance (GMP, ISO), product quality and purity, manufacturing capacity, supply reliability, price, and geographic considerations. Audits and certifications ensure adherence to international standards.

Q2: How does geopolitical tension impact API sourcing for ophthalmic drugs?
A2: It can cause import/export restrictions, supply disruptions, or increased costs. Diversifying suppliers and maintaining regional manufacturing partnerships mitigate these risks.

Q3: Are there alternatives to traditional Asian API sources for bromfenac sodium?
A3: Yes. European and North American manufacturers offer high-quality APIs, though often at higher costs. Recent developments aim to establish regional manufacturing hubs to reduce dependence.

Q4: What regulatory certifications should an API supplier ideally have?
A4: Certifications such as cGMP, ISO 9001, and compliance with pharmacopeial standards (USP, EP) are critical, especially for products used in ophthalmic applications.

Q5: What future trends will influence bromfenac sodium API procurement strategies?
A5: Increasing regional manufacturing capacity, process innovations, regulatory harmonization, and evolving global trade policies will shape sourcing approaches, emphasizing diversification and quality assurance.

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References

[1] U.S. Pharmacopeia, "Bromfenac Sodium," USP Monographs, 2021.
[2] Industry Reports, "Global NSAID API Market Outlook," IQVIA, 2022.
[3] SinoChem, "Chinese API Manufacturing Standards," 2022.
[4] Hanmi Pharmaceutical Official Website, "Ophthalmic API Capabilities," 2023.
[5] European Medicines Agency, "API Certification Guidelines," 2022.