Bulk Pharmaceutical API Sources for OLOPATADINE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for OLOPATADINE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246802
Hangzhou Trylead Chemical Technology		TL8000403
Hangzhou Trylead Chemical Technology		TL8000904
NovoSeek		5281071
NovoSeek		5282402
TCI (Tokyo Chemical Industry)		O0361
MolPort		MolPort-003-986-254

Bulk Active Pharmaceutical Ingredient (API) Sources for: Olopatadine Hydrochloride

Last updated: July 29, 2025

Introduction

Olopatadine Hydrochloride, a selective histamine H1 receptor antagonist, is primarily used in treating allergic conjunctivitis and allergic rhinitis. As a critical component in ophthalmic and nasal formulations, the quality and reliability of bulk API sourcing are paramount for pharmaceutical manufacturers. This article provides a comprehensive overview of global sources of Olopatadine Hydrochloride, emphasizing quality standards, geographic distribution, and supply chain considerations relevant to pharmaceutical industry stakeholders.

Manufacturers and Suppliers of Olopatadine Hydrochloride

Several pharmaceutical API manufacturers operate globally, offering Olopatadine Hydrochloride in various grades, including pharmaceutical, clinical, and research grades. The primary regions with active production facilities are Asia-Pacific, Europe, and North America. Key manufacturers include:

1. Sun Pharmaceutical Industries Ltd. (India): Among the largest API producers globally, Sun Pharma manufactures Olopatadine Hydrochloride, adhering to stringent cGMP standards suitable for ophthalmic formulations [1].

2. Yung Shin Pharmaceuticals Industrial Co., Ltd. (Taiwan): A prominent manufacturer with a comprehensive portfolio of APIs, Yung Shin supplies Olopatadine Hydrochloride globally, with a focus on quality and consistency [2].

3. Hetero Labs Ltd. (India): Known for producing a range of antihistaminic APIs, Hetero’s Olopatadine Hydrochloride complies with international pharmacopeias and offers competitive pricing.

4. MingFang Pharma (China): An emerging supplier providing Olopatadine Hydrochloride for global export markets, with manufacturing facilities certified according to international standards.

5. APS Pharma (India): Specialized in ophthalmic APIs, APS Pharma supplies pharma-grade Olopatadine Hydrochloride with ISO and GMP certifications.

Quality Standards and Certification

Reliable API sources must adhere to rigorous quality standards, including compliance with:

• United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.): Many suppliers produce Olopatadine Hydrochloride meeting these monographs for purity, potency, and impurity profiles.

• ISO Certifications: Certification for Quality Management (ISO 9001), Good Manufacturing Practice (GMP), and other relevant standards underpin supplier credibility.

• Regulatory Approvals: Suppliers with approvals from agencies such as the FDA, EMA, or PMDA facilitate smoother registration and compliance processes.

Supply Chain Considerations

Global supply chain dynamics significantly influence sourcing decisions:

• Geopolitical Stability: Manufacturers situated in politically stable regions tend to ensure consistent supply.

• Manufacturing Capacity and Scalability: Suppliers with large-scale production capabilities can meet increasing demand and provide supply continuity.

• Lead Time & Logistics: Efficient logistics and warehousing reduce lead times, essential for manufacturing continuity, especially during supply disruptions like the COVID-19 pandemic.

• Pricing and Contract Terms: Competitive pricing models, flexible payment conditions, and long-term supply agreements are key considerations.

Trends in API Sourcing for Olopatadine Hydrochloride

• Shift to Asia-Pacific: The region continues to dominate API manufacturing due to cost advantages, expanding capacities, and technological advancements [3].

• Increasing Focus on Quality & Regulatory Compliance: Post-2019, emphasis on cGMP compliance and transparency has heightened, with manufacturers investing in quality systems.

• Emerging Supply Chain Risks: Geopolitical tensions, raw material shortages, and regulatory changes pose ongoing risks that companies seek to mitigate through diversified supplier bases.

Major API Marketplaces and Distributors

Additionally, several intermediaries and global commodity marketplaces, including:

• Alibaba and IndiaMART: Platforms where verified API manufacturers and suppliers list Olopatadine Hydrochloride offerings.

• PharmAlibaba and ChemShuttle: Specialized chemical and pharmaceutical marketplaces providing supply chain visibility and quality assurance data.

Regulatory and Intellectual Property (IP) Landscape

Sourcing from reputable manufacturers ensures compliance with pharmaceutical regulations and mitigates infringement risks. Patents related to Olopatadine formulations may influence sourcing choices, particularly concerning generic vs. branded APIs [4].

Conclusion

Ensuring a reliable, high-quality supply of Olopatadine Hydrochloride requires careful evaluation of manufacturers based on quality standards, regulatory compliance, capacity, and supply chain stability. Asia-Pacific remains the primary hub for API production due to economic advantages, but European and North American sources offer high-quality options with advanced regulatory standing. Developing a diversified supplier base mitigates risks associated with geopolitical instabilities and market fluctuations.

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Key Takeaways

• Global Sourcing Options: Asia-Pacific, especially India and China, dominate Olopatadine Hydrochloride API manufacturing, complemented by European and North American suppliers focusing on high compliance standards.

• Quality & Regulatory Adherence: Suppliers with USP, Ph. Eur., ISO, and GMP certifications ensure API quality and facilitate regulatory approval processes.

• Supply Chain Resilience: Diversification across multiple suppliers enhances resilience against geopolitical and logistical disruptions.

• Market Trends: Increased scrutiny on quality standards and regulatory compliance in API sourcing is driving supplier selection criteria.

• Strategic Procurement: Establishing long-term agreements with trusted manufacturers and verifying certification credentials optimize supply stability.

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FAQs

1. What are the primary regions producing Olopatadine Hydrochloride API?
The main manufacturing regions include India, China, Taiwan, and certain European countries, with Asia-Pacific dominating due to cost efficiency and capacity.

2. How can pharmaceutical companies verify the quality of Olopatadine Hydrochloride API?
Verification involves checking supplier compliance with pharmacopeias (USP, Ph. Eur.), reviewing GMP certifications, audit reports, and conducting analytical testing of batches.

3. Are there regulatory restrictions on sourcing Olopatadine Hydrochloride API from certain regions?
Regulations vary; some regions may have restrictions or preferential acceptance depending on local regulatory policies and supplier certifications.

4. How do supply chain disruptions impact the availability of Olopatadine Hydrochloride API?
Disruptions, such as raw material shortages or geopolitical tensions, can lead to delays or shortages, emphasizing the importance of a diversified supplier portfolio.

5. What role do intermediaries and marketplaces play in sourcing Olopatadine Hydrochloride API?
They facilitate supplier discovery, provide quality assurance through verified listings, and streamline procurement processes for qualified APIs.

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References

[1] Sun Pharmaceutical Industries Ltd. Website. Available at: https://sunpharma.com
[2] Yung Shin Pharmaceuticals. Corporate website. Available at: https://yungshin.com
[3] IQVIA, Global API Market Trends, 2022.
[4] U.S. Patent and Trademark Office. Overview of patent landscape related to Olopatadine.