Bulk Pharmaceutical API Sources for PATADAY ONCE DAILY RELIEF

Bulk Pharmaceutical API Sources for PATADAY ONCE DAILY RELIEF

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246802
Hangzhou Trylead Chemical Technology		TL8000904
NovoSeek		5282402

Bulk Active Pharmaceutical Ingredient (API) Sources for Pataday Once Daily Relief

Last updated: July 28, 2025

Introduction

Pataday Once Daily Relief, a widely used antihistamine ophthalmic solution, provides effective allergy symptom relief, specifically targeting allergic conjunctivitis. The active pharmaceutical ingredient (API) in this product is Olopatadine hydrochloride, a selective mast cell stabilizer and antihistamine. Ensuring a reliable, high-quality supply of Olopatadine hydrochloride is critical for pharmaceutical companies to meet global demand while maintaining safety and efficacy standards. This article examines the primary sources of bulk Olopatadine hydrochloride, addressing their regulatory compliance, manufacturing capacity, supply stability, and strategic considerations for procurement.

Overview of Olopatadine Hydrochloride as API

Olopatadine hydrochloride, chemically known as 4-(1H-imidazol-4-yl)-3'-hydroxy-1,1'-biphenyl-2-carboxylic acid, is synthesized via complex chemical pathways involving multiple steps. It functions as a selective antagonist of the H1-receptor, inhibiting the release of allergic mediators and alleviating ocular allergy symptoms. The API’s purity and consistency are critical, necessitating sourcing from reputable manufacturers with robust quality assurance systems.

Global API Manufacturing Landscape

The production of Olopatadine hydrochloride is geographically dispersed. Major API manufacturers are located in regions with advanced chemical manufacturing infrastructure, including India, China, Europe, and the United States. These regions host facilities complying with Good Manufacturing Practice (GMP) standards, essential for APIs destined for ophthalmic products.

1. Indian API Manufacturers

India is a leader in generic API manufacturing, offering cost-effective solutions with significant capacity expansion in recent years.

• Sun Pharmaceutical Industries Ltd.
  A prominent player with a diversified product portfolio, Sun Pharma manufactures Olopatadine hydrochloride in compliance with international standards, catering to global markets.

• Aarti Drugs Ltd.
  These facilities are USP- and EP-compliant, with proven scale and quality control measures, offering reliable supply chains.

• Ipca Laboratories
  Recognized for high-volume production of ophthalmic APIs, Ipca's facilities are GMP-certified, making them a preferred source for multinational companies.

2. Chinese API Manufacturers

China remains a key source of active pharmaceutical ingredients, with a focus on cost efficiencies.

• Qingdao Huanghe Chemical Co., Ltd.
  An established manufacturer with ISO and GMP certifications, offering Olopatadine hydrochloride with documented quality.

• Shandong Lunan Pharmaceutical Industry Co., Ltd.
  Has capacities dedicated to ophthalmic API production, emphasizing process control and purity standards.

• Jiangxi Sanzikanghua Pharmaceutical Co., Ltd.
  Combines cost advantage with compliance to international quality standards, serving export markets.

3. European and United States API Suppliers

While the European and US markets tend to focus more on high-quality, transparent supply chains, fewer domestic manufacturers produce Olopatadine hydrochloride at large scale, often relying on imports.

• LKT Laboratories, Inc. (USA)
  An established supplier of ophthalmic APIs, providing high-purity Olopatadine hydrochloride for regulatory-approved products.

• Recipharm (Sweden)
  Offers contract manufacturing of APIs, including Olopatadine hydrochloride, emphasizing GMP compliance and rigorous testing.

4. Regulatory and Quality Considerations

For Pataday Once Daily Relief, quality assurance is paramount. Sources must demonstrate compliance with:

• GMP Certification: Essential for APIs used in ophthalmic products, ensuring consistent quality and safety.

• Pharmacopoeial Standards: API must meet USP, EP, or other recognized pharmacopoeias' standards for purity, potency, and stability.

• Environmental and Ethical Standards: Suppliers should adhere to environmental regulations and ethical manufacturing practices, including responsible resource use and waste management.

• Traceability and Documentation: Full batch documentation, certificates of analysis (CoA), and stability data are non-negotiable prerequisites.

5. Supply Chain and Capacity Considerations

In today’s volatile global supply chains, diversifying API sources mitigates risk associated with geopolitical tensions, natural disruptions, or compliance issues.

• Manufacturing Capacity Expansion: Leading producers are expanding capacity to meet increasing ophthalmic API demand, enabled by technological advancements such as continuous manufacturing.

• Long-term Supply Agreements: Establishing strategic partnerships and long-term contracts with certified manufacturers ensures supply stability and price predictability.

• Qualification and Validation: Due diligence in qualifying suppliers involves audits, sampling, and process validation to confirm capacity and compliance.

Emerging Trends in API Sourcing

• API Contract Manufacturing: Outsourcing to Contract Manufacturing Organizations (CMOs) can reduce capital expenditure and accelerate time-to-market.

• Nearshoring: Some firms explore nearshore sourcing for faster logistics and regulatory familiarity.

• Sustainable Synthesis Methods: Increasing emphasis on green chemistry reduces environmental impact and improves supply chain sustainability.

Conclusion

The primary sources of bulk Olopatadine hydrochloride for Pataday Once Daily Relief include well-established pharmaceutical manufacturers in India, China, Europe, and the United States. Each region offers unique advantages in terms of cost, capacity, and compliance. Ensuring a continuous, high-quality supply relies on rigorous qualification processes, strategic supplier partnerships, and adherence to regulatory standards. As the demand for ophthalmic antihistamines grows, manufacturers and procurement professionals must remain vigilant, balancing cost, quality, and supply chain resilience.

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Key Takeaways

• Olopatadine hydrochloride is the core API for Pataday Once Daily Relief, requiring suppliers complying with GMP and pharmacopoeial standards.
• Indian and Chinese manufacturers dominate global supply, offering cost advantage and scalable capacity, but require thorough qualification.
• European and US-based API suppliers focus on high-quality assurance, suitable for brands prioritizing purity and compliance.
• Diversifying API sources mitigates risk; long-term partnerships with certified suppliers ensure supply stability.
• Emerging manufacturing trends include contract manufacturing and green chemistry, supporting sustainable, reliable API sourcing.

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FAQs

1. What are the primary regions producing Olopatadine hydrochloride for ophthalmic use?
India and China are the leading suppliers globally, with Europe and the US offering high-quality, regulated APIs primarily through contract manufacturing organizations.

2. What quality standards should API suppliers for Pataday meet?
Suppliers must adhere to GMP regulations, and APIs should comply with USP, EP, or other recognized pharmacopoeial standards, ensuring purity, stability, and safety.

3. How can pharmaceutical companies mitigate risks in API sourcing?
By diversifying suppliers across regions, establishing long-term contracts, conducting rigorous qualification audits, and monitoring supply chain stability.

4. Are there emerging trends affecting API sourcing for ophthalmic drugs?
Yes, trends include increased use of contract manufacturing, sustainable synthesis methods, and nearshoring to enhance supply resilience and environmental sustainability.

5. What role does OEM relationship management play in API procurement?
Strong OEM relationships facilitate better communication, adherence to quality standards, and contingency planning, ensuring consistent supply and rapid response to manufacturing needs.

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References

[1] U.S. Pharmacopeia (USP). Olopatadine Hydrochloride Monograph. 2022.
[2] World Health Organization (WHO). Guidelines on Good Manufacturing Practices for Active Pharmaceutical Ingredients. 2021.
[3] Sun Pharmaceutical Industries Ltd. Official Website.
[4] Ipca Laboratories Limited. Official Website.
[5] Qingdao Huanghe Chemical Co., Ltd. Official Certification Data.