Bulk Pharmaceutical API Sources for LACRISERT

Bulk Pharmaceutical API Sources for LACRISERT

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Bulk Active Pharmaceutical Ingredient (API) Sources for: LACRISERT

Last updated: July 30, 2025

Introduction

LACRISERT (keratoconjunctivitis sicca's treatment) is a prescriptive ophthalmic insert containing hydroxypropyl cellulose (HPMC), used to manage dry eye disease. Its efficacy depends on delivering a consistent, high-quality API—hydroxypropyl cellulose (HPMC)—manufactured under strict pharmacopeial conditions. As a semi-synthetic polymer rather than a traditional small-molecule API, sourcing HPMC involves a specialized supply chain emphasizing pharmaceutical grade quality, regulatory compliance, and manufacturing stability.

Understanding Hydroxypropyl Cellulose as API for LACRISERT

HPMC functions as a viscosity-enhancing and film-forming agent within LACRISERT. While not a conventional API in the classical pharmacological sense, HPMC serves as a critical active component that modulates drug delivery, bioavailability, and therapeutic performance. Its quality directly impacts the safety and efficacy of the final ophthalmic product.

Major Suppliers of HPMC for Pharmaceutical Use

The global supply chain for pharmaceutical-grade HPMC comprises several reputable manufacturers recognized for their high-purity products, regulatory compliance, and consistent supply capabilities. Below, we analyze leading API sources suitable for LACRISERT production.

1. Ashland Global Holdings Inc.

Overview:
Ashland is a leading provider of HPMC, with extensive experience in supplying pharmaceutical-grade polymers. Their HPMC products, marketed under the brand name "Benecel," are approved for ophthalmic and other medicinal applications.

Strengths:

• Stringent quality control aligned with USP, EP, and other pharmacopeias.
• Proven track record for supply stability and regulatory compliance.
• Wide range of grades tailored for ophthalmic applications, including clear, low-amine, and high-viscosity options.

Regulatory and Quality Certifications:

• ISO 9001:2015 certified manufacturing facilities
• US FDA-approved manufacturing facilities for pharmaceutical excipients

2. Dow Wolff Cellulosics (DuPont) – presently part of Ineos

Overview:
Dow's HPMC, marketed as "Pharmacoat," supplies high-quality cellulose derivatives used in ophthalmic and other pharmaceutical formulations.

Strengths:

• Extensive research and development backing.
• Compliant with pharmacopeial standards (USP, EP).
• Proven manufacturing consistency and product purity suitable for ophthalmic insert formulations.

Certifications:

• cGMP-compliant manufacturing facilities
• Regulatory approvals for pharmaceutical applications in the US, EU, and globally

3. Shin-Etsu Chemical Co., Ltd.

Overview:
Shin-Etsu offers pharmaceutical-grade HPMC with a focus on high-purity polymers suitable for ophthalmic devices like LACRISERT.

Strengths:

• Advanced synthesis process yielding consistent product quality.
• Extensive portfolio of HPMC grades tailored to eye drops, gels, and insert formulations.
• Commitment to regulatory compliance and global distribution.

Certifications:

• GMP-certified manufacturing sites
• Compliant with international pharmacopeias

4. MedPharm Ltd.

Overview:
A contract manufacturer specializing in pharmaceutical excipients, MedPharm sources high-grade HPMC suitable for ophthalmic applications.

Strengths:

• Customizable grades and formulations for niche applications.
• Strict adherence to GMP and pharmacopeial standards.
• Established relationships with major pharmaceutical companies for supply chain security.

Regulatory Standing:

• ISO 9001 and 13485 certifications
• Supply approvals for regulated markets

5. DAIFUKU Co., Ltd.

Overview:
While primarily a packaging and manufacturing company, DAIFUKU also distributes pharmaceutical excipients, including HPMC, with a focus on Asian markets.

Strengths:

• Competitive sourcing options for regional production.
• Quality assurance aligned with local regulatory standards.

Limitations:

• May require validation for global regulatory submissions due to regional sourcing.

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Criteria for Selecting API Suppliers for LACRISERT

Choosing the appropriate bulk HPMC supplier involves stringent criteria:

• Regulatory Compliance: Suppliers must furnish documentation demonstrating conformity with USP, EP, JP, or other relevant pharmacopeias.
• Quality Assurance: Certificates of Analysis (CoA), lot traceability, and stability data are crucial.
• Manufacturing Standards: Suppliers must operate GMP-compliant facilities adhering to international standards.
• Supply Stability: Ability to supply consistent batches over extended periods, reducing risk for LACRISERT manufacturing.
• Product Purity and Compatibility: Grade selection should ensure minimal endotoxin, heavy metals, residual solvents, and appropriate viscosity.

Emerging and Regional API Sources

Some regional manufacturers in India, China, and Eastern Europe are developing pharmaceutical-grade HPMC, often at more competitive prices. However, rigorous validation and qualification processes are essential before integrating these sources into commercial manufacturing.

Regulatory and Logistical Considerations

For ophthalmic applications like LACRISERT, regulatory authorities scrutinize excipient sourcing. Suppliers must provide comprehensive documentation such as:

• Manufacturing process details
• Analytical test reports
• Stability data
• Regulatory approvals or certifications

Importantly, the selection process should include auditing supplier facilities and validating consistency through stability and compatibility studies.

Conclusion

Hydroxypropyl cellulose remains the predominant API component for LACRISERT, with key global suppliers like Ashland, Dow, and Shin-Etsu offering high-quality, regulated-grade products. The choice of supplier impacts product safety, regulatory approval, and manufacturing stability. Pharmaceutical companies must perform comprehensive due diligence, encompassing quality specifications, regulatory status, and supply chain resilience, to optimize APIs procurement for ophthalmic inserts.

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Key Takeaways

• High-Quality Sourcing: For LACRISERT, secure pharmaceutical-grade HPMC from established suppliers with proven regulatory compliance and manufacturing excellence.
• Regulatory Readiness: Ensure supplier documentation meets stringent pharmacopeia standards and aligns with target markets' regulatory requirements.
• Supply Chain Security: Prioritize suppliers with demonstrated capacity for consistent, long-term supply to mitigate production risks.
• Qualification and Validation: Conduct thorough qualification, including analytical testing, stability, and compatibility assessments, before vendor qualification.
• Regional Considerations: While emerging regional APIs may offer cost advantages, rigorous validation is essential for global regulatory acceptance.

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FAQs

1. Is hydroxypropyl cellulose considered an active pharmaceutical ingredient for LACRISERT?
Yes. Although it is a polymer and not a traditional small-molecule API, HPMC acts as the critical active component influencing the performance of LACRISERT.

2. Can I source HPMC from regional suppliers for ophthalmic applications?
Regional suppliers may offer competitive options; however, due diligence regarding quality, regulatory compliance, and supply stability is crucial before qualification for ophthalmic use.

3. What quality standards should HPMC suppliers meet for ophthalmic product manufacturing?
Suppliers should furnish GMP certification and documentation demonstrating compliance with pharmacopeial standards such as USP, EP, or JP, ensuring purity, safety, and consistency.

4. How does the choice of HPMC supplier affect the regulatory approval of LACRISERT?
Utilizing suppliers with approved, GMP-compliant, and well-documented HPMC batches facilitates smoother regulatory submission processes and reduces approval timelines.

5. Are there any specific grades of HPMC recommended for LACRISERT production?
Yes. Grades characterized by low endotoxin levels, appropriate viscosity (e.g., 10-100 mPa·s), and high purity are preferred to ensure compatibility and safety in ophthalmic formulations.

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References

[1] Ashland Global Holdings Inc. Technical datasheets on pharmaceutical-grade HPMC.
[2] Dow Wolff Cellulosics product specifications for ophthalmic applications.
[3] Shin-Etsu Chemical Co., Ltd. pharmacopeial standards and product datasheets.
[4] USP Monograph on Hydroxypropyl Methylcellulose, USP-NF.
[5] Regulatory guidelines on pharmaceutical excipient sourcing for ophthalmic products.