Bulk Pharmaceutical API Sources for pemirolast potassium

Bulk Pharmaceutical API Sources for pemirolast potassium

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		443866
MolPort		MolPort-005-934-473
ISpharm		I14-14049

Bulk Active Pharmaceutical Ingredient (API) Sources for Pemirolast Potassium

Last updated: August 2, 2025

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Introduction

Pemirolast potassium is an anti-allergic agent classified under mast cell stabilizers, primarily utilized in ophthalmic and allergic conditions. As a critical component in pharmaceutical manufacturing, sourcing high-quality bulk active pharmaceutical ingredients (APIs) like pemirolast potassium is essential for drug safety, efficacy, and regulatory compliance. This article evaluates the global landscape of API suppliers, examining manufacturing locations, quality standards, and strategic considerations for pharmaceutical companies seeking reliable sources.

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Overview of Pemirolast Potassium

Pemirolast potassium is a synthetic anti-allergic compound that stabilizes mast cells, preventing the release of histamine and other inflammatory mediators. Its therapeutic applications predominantly include allergic conjunctivitis, allergic rhinitis, and certain inflammatory ocular conditions (1). The API’s chemical purity, bioavailability, and consistent supply chain are fundamental for successful formulation and commercialization.

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Global API Manufacturing Landscape

1. Major API Manufacturing Regions

The production of pemirolast potassium is concentrated in key regions with established specialty chemical and pharmaceutical manufacturing sectors:

• India: Emerging as a dominant API supplier with several GMP-compliant manufacturers leveraging cost-effective manufacturing and robust regulatory frameworks.
• China: Leading producer with large-scale facilities offering competitive pricing and extensive manufacturing capacity, though regulatory transparency varies.
• Europe: Focused on high-quality, cGMP-compliant suppliers, often serving premium markets with strict regulatory standards.
• United States: Limited direct manufacturing of APIs like pemirolast potassium; instead, US-based companies often source from Asia or Europe and perform final formulation locally.

2. Key Manufacturers and Suppliers

The list below highlights notable API manufacturers for pemirolast potassium across the primary regions:

• Indian Manufacturers:
  • Sun Pharmaceutical Industries Ltd. — Certified GMP facilities with extensive experience in antihistamines and mast cell stabilizers.
  • Glenmark Pharmaceuticals — Known for robust R&D and high-quality APIs.
  • Aurobindo Pharma — Offers API manufacturing with a focus on compliance and reliability.
• Chinese Manufacturers:
  • Huzhou Lianyang Pharmaceutical Co., Ltd. — Specializes in anti-allergic and ophthalmic APIs; GMP-certified.
  • Shandong Lijie Chemical Co., Ltd. — Competitive pricing and large-scale production capacity suggest broader supply options.
• European Suppliers:
  • Sanofi Specializes in high-purity APIs, primarily serving European markets and global clients requiring strict regulatory adherence.
• United States:
  • Typically, US companies import from Asian or European manufacturers; few domestic API producers supply pemirolast potassium directly.

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Quality Standards and Regulatory Considerations

Quality assurance is paramount when sourcing APIs:

• GMP Certification: Ensures manufacturing adherence to Good Manufacturing Practices, critical for regulatory approval.
• Pharmacopoeial Compliance: APIs must meet specifications outlined in pharmacopeial standards like USP, EP, or JP.
• Documentation: Certificates of Analysis (CoA), Batch Records, and Toxicology Data are essential for validation.
• Supplier Audits: Due diligence involves factory audits and testing samples independently to verify purity and stability.

Sourcing from certified and reputable suppliers minimizes regulatory risks and secures consistent product quality.

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Supply Chain Dynamics and Strategic Sourcing

1. Factors Influencing Source Selection

• Cost Efficiency: Asian manufacturers often offer competitive pricing due to lower production costs.
• Quality and Compliance: European and North American suppliers may command premium prices but ensure higher assurance levels.
• Supply Stability: Long-term contracts or multiple sourcing strategies mitigate risks of shortages.
• Regulatory Support: Suppliers with established regulatory documentation streamline process validation and registration.

2. Challenges in Sourcing Pemirolast Potassium APIs

• Regulatory Variability: Differing standards across jurisdictions necessitate rigorous quality control.
• Supply Chain Disruptions: Geopolitical issues, manufacturing bottlenecks, or external shocks can affect availability.
• Intellectual Property: While APIs like pemirolast potassium are generally off-patent, due diligence ensures compliance with licensing restrictions.

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Emerging Trends and Future Outlook

The API market is evolving with increased emphasis on:

• Regulatory Harmonization: Global standards aim to streamline approvals and enhance API quality.
• Supply Chain Digitization: Use of digital platforms facilitates supplier verification and real-time tracking.
• Sustainable Manufacturing: Growing focus on environmentally responsible practices influences sourcing decisions.

Forecasts indicate a continued expansion in API production capacity in India and China, aligned with global pharmaceutical demand growth.

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Key Factors for Effective API Sourcing

• Prioritize suppliers with proven compliance and GMP standards.
• Maintain diversified supplier networks to mitigate risks.
• Conduct rigorous quality assessments and audits.
• Align sourcing strategies with regulatory pathways in target markets.
• Embrace supply chain transparency and traceability solutions.

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Conclusion

Sourcing bulk pemirolast potassium APIs requires a strategic approach emphasizing quality, regulatory compliance, cost, and supply stability. Leading manufacturers in India, China, and Europe offer extensive options, with India and China dominating the market due to their manufacturing capacity and cost advantages. Pharmaceutical companies should perform diligent supplier evaluations, prioritize GMP-certified facilities, and establish long-term partnerships to ensure uninterrupted supply and regulatory compliance.

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Key Takeaways

• India and China are primary global sources for bulk pemirolast potassium, offering cost-effective, large-scale manufacturing.
• European suppliers provide high-purity APIs aligned with stringent regulatory standards, suitable for premium markets.
• Quality assurance, GMP compliance, and thorough supplier vetting are crucial to mitigate regulatory and supply chain risks.
• Diversified sourcing and digital supply chain management enhance resilience.
• The API market will continue evolving towards greater regulatory harmonization and sustainable manufacturing practices.

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Frequently Asked Questions (FAQs)

1. Is pemirolast potassium API widely available globally?
Yes, major API manufacturers in India, China, and Europe supply pemirolast potassium, ensuring broad availability provided quality standards are met.

2. What should companies prioritize when selecting an API supplier for pemirolast potassium?
Quality assurance, GMP certification, compliance with pharmacopeial standards, supply stability, and transparent documentation are top priorities.

3. Are there regulatory hurdles associated with sourcing pemirolast potassium APIs from Asia?
Potential hurdles include differing regulatory standards; however, GMP-certified suppliers and comprehensive documentation mitigate these concerns.

4. How does the COVID-19 pandemic impact the supply of pemirolast potassium APIs?
Disruptions may occur due to manufacturing shutdowns, logistical challenges, and increased demand, making supply chain diversification critical.

5. Will the demand for pemirolast potassium APIs increase in the future?
With rising prevalence of allergic conditions and expanding ophthalmic applications, API demand is expected to grow steadily.

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Sources
[1] U.S. Pharmacopeia, "Pemirolast Potassium," USP.