Bulk Pharmaceutical API Sources for ticagrelor

Bulk Pharmaceutical API Sources for ticagrelor

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS015900739
MedChemexpress MCE		HY-10064
AbaChemScene		CS-0619
Molport		MolPort-023-329-971
BOC Sciences		274693-27-5

Bulk Active Pharmaceutical Ingredient (API) Sources for: Ticagrelor

Last updated: July 28, 2025

Introduction

Ticagrelor, marketed primarily under the brand name Brilinta, is an antiplatelet agent indicated for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS). As a potent reversible P2Y12 receptor antagonist, ticagrelor plays a pivotal role in secondary prevention of myocardial infarction and stroke. The production and procurement of high-quality bulk Active Pharmaceutical Ingredient (API) are critical to ensuring drug efficacy, safety, regulatory compliance, and cost-effectiveness. This article explores the global landscape of ticagrelor API sourcing, assessing manufacturers’ profiles, geographic distribution, regulatory considerations, and market dynamics.

Manufacturers of Ticagrelor API: Key Players

1. Original Equipment Manufacturer (OEM): AstraZeneca

AstraZeneca holds exclusive rights to ticagrelor’s synthesis, manufacturing, and marketing—having developed the molecule through extensive R&D investment, culminating in the FDA approval in 2011 and subsequent global approvals. The company maintains control over the supply chain, ensuring API quality and compliance with regulatory standards. While AstraZeneca primarily supplies ticagrelor for its branded formulations, it may also engage in licensed manufacturing agreements with third-party manufacturers for generic or OEM production, subject to licensing, patent rights, and regional regulations.

2. Contract Manufacturing Organizations (CMOs)

In recent years, the outsourcing trend has seen several CMOs and chemical producers establish capabilities to synthesize ticagrelor API either temporarily or permanently. These third-party suppliers often serve generic manufacturers or research institutions:

• Dr. Reddy’s Laboratories: Known for developing APIs in cardiovascular domains, Reddy’s has capacity to produce ticagrelor API, potentially leveraging proprietary process routes or licensing agreements.

• Cipla Limited: As part of its extensive API portfolio, Cipla claims manufacturing capabilities for complex APIs, possibly including ticagrelor, adhering to cGMP standards.

• Biotech and Chemical Contract Manufacturers: Several East Asian, Indian, and European API producers, such as Zhejiang Hisun Pharmaceutical Co., Ltd., and Zhejiang Huahai Pharmaceutical Co., Ltd., have expanded their portfolio to include ticagrelor API, driven by regional market demands.

Geographic Distribution of Ticagrelor API Suppliers

Asia-Pacific Region

Indian and Chinese chemical firms dominate the API manufacturing landscape, given their cost efficiencies, mature chemical synthesis infrastructure, and growing API export capabilities. Indian firms like Torrent Pharmaceuticals, Sun Pharmaceutical Industries, and Aurobindo Pharma have either developed or are capable of producing ticagrelor API, aligning with India’s broader pharmaceutical export strategy.

Chinese manufacturers such as Zhejiang Hisun and Zhejiang Huahai possess scalable synthetic routes, often employing cost-effective chemical processes to meet global demand. These suppliers typically adhere to ICH guidelines and are inspected periodically by regulatory agencies such as the FDA and EMA, facilitating their export to markets requiring strict compliance.

Europe and North America

While fewer European and North American manufacturers produce ticagrelor API directly, some engage in licensing, contract synthesis, or market-specific manufacturing. AstraZeneca's in-house facility remains the primary North American source, ensuring high quality and regulatory compliance.

Latin America and Africa

Regional API production remains limited due to market size and infrastructure constraints, often relying on imported APIs from Asia-Pacific or licensed manufacturing arrangements to meet local demand.

Regulatory and Quality Considerations

API sourcing strategies must address regulatory requirements—particularly, compliance with current Good Manufacturing Practices (cGMP), active pharmaceutical ingredient standards (such as USP, EP, JP), and dossier submissions. Many Asian suppliers have achieved approvals or prequalification statuses from WHO, USFDA, and EMA, which are prerequisites for global distribution.

Quality assurance extends to impurity profiling, solvent residues, and batch-to-batch consistency. Manufacturers qualified for high-volume production often hold certifications such as ISO 9001, ISO 13485, and sometimes possess process patents that influence licensing and pricing.

Market Dynamics and Sourcing Strategies

The patent exclusivity of ticagrelor, held by AstraZeneca until 2022-2023, initially limited generic production. Post patent expiry, multiple generic manufacturers entered the market, employing different sourcing strategies:

• Licensed manufacturing: Generics companies obtaining licensed API from AstraZeneca or its authorized suppliers.

• In-house synthesis: Larger pharmaceutical firms investing in establishing their own API synthesis capabilities to ensure supply chain control.

• Third-party API sourcing: Reliance on external API manufacturers, especially in India and China, for cost reduction and flexible supply.

The ongoing trend favors diversification of suppliers to reduce supply chain risks, ensure competitive pricing, and meet regional regulatory requirements.

Supply Chain Considerations and Challenges

Supply chain resilience factors, such as geopolitical tensions, trade tariffs, and raw material availability, influence API sourcing choices for ticagrelor. COVID-19 pandemic disruptions highlighted vulnerabilities, prompting companies to diversify suppliers and establish regional manufacturing hubs. Ensuring quality compliance during rapid scale-up remains a challenge, necessitating close regulatory oversight and supplier audits.

Emerging Trends and Future Outlook

• Increased localization: Some regions aim to develop domestic ticagrelor API manufacturing to reduce dependency on Asian suppliers and improve supply security.

• Process innovation: Continuous advancements in synthetic routes aim to improve yields, reduce costs, and minimize environmental impact, broadening supplier options.

• Regulatory harmonization: Adoption of common standards simplifies cross-border API sourcing, facilitating more flexible supply chains.

• Patent landscape evolution: As patents expire and generic competition intensifies, sourcing strategies will shift toward more cost-effective, high-volume API suppliers.

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Key Takeaways

• Dominant manufacturers: AstraZeneca remains the primary source for ticagrelor API under patent protection; post-expiry, Indian and Chinese producers have expanded their capabilities, providing cost-effective alternatives.

• Geographic diversity: Asian manufacturers, particularly from India and China, lead API production with compliant, scalable processes, supported by international regulatory recognition.

• Regulatory compliance: Ensuring API suppliers meet cGMP standards, quality certifications, and have robust validation processes is critical to supply chain security.

• Market dynamics: Post-patent expiry, sourcing strategies diversify, emphasizing licensing, contract manufacturing, and in-house capacity to balance cost, quality, and supply risks.

• Future trends: Process innovations, regional manufacturing initiatives, and regulatory harmonization are shaping ticagrelor API supply landscape, with an increasing emphasis on supply resilience and cost efficiency.

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FAQs

1. Who manufactures the original ticagrelor API?
AstraZeneca holds exclusive rights to the original ticagrelor API manufacturing process, utilizing its proprietary synthetic route through authorized facilities.

2. Are there generic ticagrelor APIs available on the market?
Yes, following patent expiry, multiple generic manufacturers in India and China have developed licensed or self-developed APIs, subject to regional regulatory approvals.

3. What are the key regulatory considerations when sourcing ticagrelor API?
Suppliers should demonstrate compliance with cGMP standards, hold relevant certifications (e.g., USFDA, EMA, WHO approvals), and provide batch documentation, impurity profiles, and stability data consistent with regulatory expectations.

4. How does API quality impact drug safety and efficacy?
High-quality APIs prevent impurity-related adverse effects, ensure consistent pharmacological activity, and streamline regulatory approval processes. Defects or variability in API quality can compromise drug performance and patient safety.

5. What factors influence the choice of API supplier for ticagrelor?
Factors include regulatory compliance, cost, supply reliability, quality standards, geographic location, manufacturing capacity, and the supplier’s history of quality assurance.

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References

[1] AstraZeneca. (2011). Brilinta (ticagrelor) prescribing information.
[2] US Food and Drug Administration. (2022). Approved Drugs Database.
[3] World Health Organization. (2020). WHO Prequalified Essential Medicines.
[4] Market research reports on API manufacturing trends.
[5] Industry publications on recent patent expiries and generic competition.