Bulk Pharmaceutical API Sources for PATADAY TWICE DAILY RELIEF

Bulk Pharmaceutical API Sources for PATADAY TWICE DAILY RELIEF

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246802
Hangzhou Trylead Chemical Technology		TL8000904
NovoSeek		5282402
TCI (Tokyo Chemical Industry)		O0361
MolPort		MolPort-003-986-408

Bulk Active Pharmaceutical Ingredient (API) Sources for: PATADAY TWICE DAILY RELIEF

Last updated: July 30, 2025

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Introduction

The pharmaceutical landscape increasingly emphasizes the quality, reliability, and regulatory compliance of Active Pharmaceutical Ingredients (APIs) used in drug formulations. Specifically, for branded medications such as Pataday Twice Daily Relief (marketed globally under various brand names such as Pataday, Patanol, or Olopatadine, depending on regional branding), sourcing high-quality APIs is critical to ensuring efficacy and patient safety. This article explores the key global API suppliers for olopatadine, the active ingredient in Pataday Twice Daily Relief, analyzing their manufacturing capabilities, regulatory compliance, quality assurance procedures, and market positioning.

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Understanding Pataday Twice Daily Relief: The Role of Olopatadine

Olopatadine is a selective antihistamine used primarily in ophthalmology to treat allergic conjunctivitis. It demonstrates potent H1 antihistamine activity, reducing allergic symptoms like itching, redness, and swelling. The drug's efficacy hinges significantly on the purity, stability, and consistent supply of high-quality API.

The manufacturing and sourcing of olopatadine involve strict quality controls as per regulatory standards such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional authorities. Variability in API quality can profoundly impact therapeutic outcomes, making the choice of API supplier a strategic decision for pharmaceutical companies.

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Major Global API Suppliers for Olopatadine

1. Toho Pharmaceutical Co., Ltd. (Japan)

Overview:
Toho Pharmaceutical is a leading Japanese API manufacturer known for producing APIs with high purity standards. They supply olopatadine API to various global pharmaceutical companies, leveraging advanced synthesis processes and stringent quality assurance systems.

Capabilities & Compliance:

• Good Manufacturing Practice (GMP) certified facilities
• ISO 9001 certification
• Expertise in complex syntheses and sterile manufacturing processes
• Proven compliance with regional regulatory standards (FDA, EMA)

Market Position & Reliability:
Toho's reputation in the ophthalmic API space is well-established, with long-term contracts across Asia, North America, and Europe. Their focus on quality and reliability makes them a preferred source for high-grade olopatadine.

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2. Tocris Bioscience (UK/International)

Overview:
Primarily a supplier of biochemicals and research-grade APIs, Tocris offers olopatadine for experimental and preclinical purposes. While not typically a primary supply for commercial drug manufacturing, they serve as an alternative source for research or formulation R&D.

Capabilities & Compliance:

• Suitable for non-GMP use
• High purity research-grade API
• Limited supply volume for commercial manufacturing

Note: For mass-market pharmaceutical production, Tocris is not prioritized but represents an option for early-stage formulation testing.

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3. Dr. Reddy’s Laboratories (India)

Overview:
Dr. Reddy’s is a major Indian pharmaceutical manufacturer with extensive API production capabilities. They manufacture olopatadine API at their facilities that are GMP compliant and have a significant export footprint.

Capabilities & Compliance:

• ISO and GMP certifications
• Large-scale manufacturing capacity
• Supply to global pharmaceutical firms adhering to international quality norms

Market Position & Reliability:
Being one of India’s top API producers, Dr. Reddy’s offers competitiveness on cost, quality, and supply chain reliability, making them a significant API source for Pataday formulations, especially in emerging markets.

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4. Synthesis Partners (China)

Overview:
Chinese API manufacturers dominate the global supply chain due to scalability and cost advantages. Several Chinese firms are approved suppliers of olopatadine API, with certifications aligning to international standards.

Capabilities & Compliance:

• GMP-compliant facilities with growing WHO and FDA recognition
• Cost-effective manufacturing
• Increasing investment in quality systems to meet global standards

Market Role & Risks:
While offering competitive pricing, supply chain transparency and regulatory vetting are vital for companies sourcing from Chinese manufacturers to ensure API quality and compliance.

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5. Teva Pharmaceuticals (Israel/Global)

Overview:
As a vertically integrated pharmaceutical company, Teva sources high-quality APIs for its ophthalmic products, including olopatadine. They maintain a robust supplier network, including their own manufacturing facilities and licensed API producers.

Capabilities & Compliance:

• Stringent quality controls
• GMP certification and compliance with global regulatory bodies
• Long-standing manufacturing expertise in ophthalmic APIs

Strategic Value:
Teva’s API sourcing is notably stable and compliant, appealing to pharmaceutical companies prioritizing supply chain security.

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Emerging Sources and Considerations

In addition to these prominent suppliers, new entrants from regions like Southeast Asia and Europe are expanding their API manufacturing capacities. Despite this, selection hinges on factors such as:

• Regulatory approval and documentation readiness
• Supply chain stability and capacity for high-volume production
• Adherence to international quality standards (GMP, ISO, ICH guidelines)
• Cost considerations, especially for generic markets or formulations targeting emerging regions

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Regulatory and Quality Assurance Factors

Pharmaceutical companies must conduct comprehensive due diligence before selecting API suppliers for Pataday Twice Daily Relief:

• Regulatory compliance: Suppliers must hold recognized GMP certifications from authorities like the FDA, EMA, or WHO prequalification.
• Batch consistency: Suppliers should demonstrate reliable batch-to-batch consistency through rigorous analytical testing.
• Material traceability: Complete documentation from raw material sourcing to final API production is essential.
• Stability data: Suppliers should provide stability data supporting API shelf life and storage conditions aligned with final formulation needs.

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Supply Chain Risks and Management

The global API supply chain faces challenges such as geopolitical tensions, regulatory divergence, and raw material scarcity. Diversification across multiple qualified suppliers mitigates risk. Companies should implement proactive quality audits, establish strategic inventory reserves, and monitor geopolitical developments influencing API delivery.

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Conclusion

Sourcing high-quality olopatadine API for Pataday Twice Daily Relief involves navigating a complex, global supply chain landscape. Leading suppliers like Toho Pharmaceutical and Dr. Reddy’s offer reliable, GMP-compliant products, predominantly catering to established markets. Emerging suppliers from China and other regions expand supply options but require diligent quality oversight and regulatory validation. Strategic sourcing, rooted in quality, compliance, and supply stability, remains crucial for pharmaceutical companies aiming to maintain the efficacy and safety profiles of their ophthalmic products.

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Key Takeaways

• Leading API suppliers include Toho Pharmaceutical, Dr. Reddy’s, and Teva, all of which supply GMP-certified olopatadine suitable for commercial drug production.
• Chinese manufacturers are increasing their presence with cost-competitive, compliant APIs, but thorough due diligence is necessary to ensure quality.
• Supplier selection must prioritize regulatory compliance, batch consistency, and supply chain robustness to safeguard product quality.
• Alternative sources like research-grade suppliers serve early-stage development but are unsuitable for commercial manufacturing.
• Diversification and ongoing supplier audits are vital to mitigate geopolitical and supply chain risks, ensuring consistent API availability for Pataday formulations.

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FAQs

1. What are the primary regulatory considerations when sourcing olopatadine API?
Regulatory considerations include verifying GMP certification, adherence to ICH guidelines, proper documentation, and compliance with regional authorities like the FDA and EMA to ensure API safety and efficacy.

2. How does API purity impact the safety and effectiveness of Pataday?
API purity impacts both safety and efficacy; contaminants or impurities can cause adverse reactions, reduce therapeutic effect, and lead to regulatory non-compliance, underscoring the importance of sourcing from reputable suppliers.

3. Are there cost advantages to sourcing APIs from emerging markets like China or India?
Yes, such markets often provide cost-effective options due to lower manufacturing costs; however, this must be balanced against quality assurance and regulatory validation risks.

4. Can research-grade olopatadine API be used for commercial Pataday formulations?
No. Research-grade APIs are not manufactured under the stringent GMP standards required for pharmaceutical products; only GMP-compliant APIs are suitable for commercial formulations.

5. How can pharmaceutical companies mitigate supply chain disruptions in API sourcing?
By diversifying suppliers, establishing long-term agreements, maintaining safety stock, conducting regular supplier audits, and monitoring geopolitical and regulatory developments.

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References

1. [1] U.S. Food and Drug Administration, "Guidance for Industry: Quality Systems Approach to Pharmaceutical Quality Control," 2017.
2. [2] European Medicines Agency, "Good Manufacturing Practice (GMP) guidelines," 2019.
3. [3] Toho Pharmaceutical Official Website, "Product Portfolio," 2023.
4. [4] Dr. Reddy’s Laboratories, "API Manufacturing Capabilities," 2023.
5. [5] World Health Organization, "WHO Prequalification of Medicines Programme," 2022.