Bulk Pharmaceutical API Sources for tirofiban hydrochloride

Bulk Pharmaceutical API Sources for tirofiban hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-006-823-927
Amadis Chemical		A807902
AbaChemScene		CS-0948
MedChemexpress MCE		HY-17369
AstaTech, Inc.		40294
Finetech Industry Limited		FT-0631165

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

Last updated: August 1, 2025

---

Introduction

Tirofiban hydrochloride is a potent antiplatelet agent used primarily in the management of acute coronary syndromes (ACS), including unstable angina and non-ST elevation myocardial infarction (NSTEMI). Its mechanism, a reversible antagonist of the glycoprotein IIb/IIIa receptor, inhibits platelet aggregation, reducing thrombotic events. Given its critical role in cardiovascular therapy, high-quality bulk API sourcing is vital to meet strict regulatory standards and ensure consistent drug efficacy.

This article provides a comprehensive overview of the leading global sources of tirofiban hydrochloride API, considering quality, regulatory compliance, manufacturing capabilities, and supply stability to assist pharmaceutical companies in strategic sourcing decisions.

---

Global API Manufacturing Landscape for Tirofiban Hydrochloride

1. Contract Manufacturing Organizations (CMOs)

Major pharmaceutical manufacturers outsource API production to specialized CMOs, which often operate under rigorous quality standards such as cGMP (current Good Manufacturing Practice). Several prominent CMOs globally have established capabilities for tirofiban hydrochloride synthesis, with a focus on ensuring adherence to regulatory requirements of major markets including the U.S., EU, and Asia.

Key CMO Sources:

• Fujifilm Diosynth Biotechnologies (U.S., UK)
  While predominantly biopharmaceuticals-focused, Fujifilm's chemical manufacturing division produces small-molecule APIs, including complex peptides and thrombotic agents. Their high-quality standards and extensive regulatory experience make them a significant provider for specialized APIs, including tirofiban hydrochloride, especially for clients prioritizing supply reliability and compliance.

• Bachem (Switzerland, U.S.)
  Recognized for peptide synthesis expertise, Bachem supplies customized APIs and intermediates. Although their core is peptide chemistry, they have expanded into small molecule APIs, including agents like tirofiban hydrochloride, with strong GMP certifications and quality assurance records.

• WuXi AppTec (China)
  As a leading global contract manufacturer, WuXi provides comprehensive API synthesis services, including complex cardiovascular drugs. Their large-scale facilities, compliance with global standards, and capacity for large-volume production position them as a top Asian API supplier.

• Hikal Ltd. (India)
  Specializing in custom synthesis and API manufacturing, Hikal offers bulk tirofiban hydrochloride at competitive prices, with certifications aligned to international regulatory standards. They emphasize stringent quality control and robust supply chains.

• Shandong Jida Pharmaceutical Co., Ltd. (China)
  Focused on cardiovascular API production, this manufacturer is known for affordable manufacturing costs, strategic Asian-market supply, and compliance with cGMP and ISO standards, making them a key regional source.

---

2. Market-Leading API Suppliers

Independent API suppliers with extensive regulatory dossiers and reputation for quality control are preferred sources. These organizations often serve as primary vendors globally or as regional suppliers in Asia, Europe, and North America.

Prominent Global API Vendors:

• Viatris (formerly Mylan and Pfizer API divisions)
  Viatris maintains a robust portfolio of cardiovascular APIs, including tirofiban hydrochloride, with production sites compliant with major regulatory agencies. Their focus on quality and supply chain stability makes them a preferred choice for multinational pharmaceutical companies.

• Sun Pharmaceutical Industries Ltd.
  An Indian-based pharmaceutical giant with extensive API manufacturing facilities, Sun Pharma supplies tirofiban hydrochloride with validated quality systems and a focus on cost-effective supply.

• Aurobindo Pharma
  An established Indian API manufacturer, Aurobindo offers high-quality tirofiban hydrochloride, leveraging extensive manufacturing experience and proven compliance records.

• Hikma Pharmaceuticals
  Though primarily known for branded generics, Hikma also supplies bulk APIs with high regulatory standards, including cardiovascular agents like tirofiban hydrochloride, serving both domestic and export markets.

---

3. Regulatory Considerations for API Sourcing

Regulatory compliance determines the acceptability of APIs across key markets. Suppliers must demonstrate adherence to cGMP standards, complete validation dossiers, and rigorous quality control.

• USFDA-Registered Suppliers: These providers ensure compliance with the Food and Drug Administration, facilitating easier registration and market approval.

• EMA and MHRA Certification: European suppliers possessing certifications from the European Medicines Agency or the UK's MHRA are advantageous for exporting to Europe.

• ISO and Other Certifications: ISO 9001, ISO 13485 (for medical devices), and related certifications affirm quality management processes, crucial for internationally compliant API manufacturing.

---

4. Supply Chain Stability & Capacity

The global pharmaceutical supply chain faces ongoing challenges, including geopolitical influences and raw material availability. Leading API manufacturers have diversified manufacturing locations, capacity expansion initiatives, and inventory management strategies to guarantee continuous supply.

• Asia-Pacific: China and India dominate API manufacturing for tirofiban hydrochloride, offering cost advantages and large-scale production. However, regulatory nuances may require diligent supplier vetting.

• North America and Europe: While fewer in number, these regions focus on high-quality, validated production sites meeting stringent regulatory standards, often at higher costs but with enhanced supply security.

Manufacturers with demonstrated ability to scale production in response to demand surges provide added value for high-volume therapeutic applications.

---

5. Quality Assurance & Certification

High product quality hinges on comprehensive quality assurance protocols, validated manufacturing processes, and consistent batch-to-batch reproducibility. Suppliers with extensive validation histories, stability data, and robust analytical testing frameworks are preferred.

Certifications not only indicate regulatory compliance but also reflect a supplier’s commitment to manufacturing excellence:

• cGMP Compliance
• ISO 9001 Certification
• Good Laboratory Practice (GLP) adherence
• Validated analytical procedures

---

6. Strategic Sourcing Recommendations

Pharmaceutical companies should evaluate potential API suppliers based on:

• Regulatory Track Record: Suppliers with approved dossiers and a history of regulatory compliance streamline registration processes.

• Manufacturing Capacity: Capability for large-volume, consistent supply reduces risk of shortages.

• Quality Certifications: Prioritize suppliers with cGMP, ISO, and other relevant certifications.

• Cost and Lead Time: Balance cost efficiency with supply reliability; regions with stable political environments and mature manufacturing standards are favorable.

• Technical Capabilities: Verify supplier expertise in complex peptide synthesis and hydrochloride salt formulations crucial for tirofiban.

---

Conclusion

Reliable sourcing of tirofiban hydrochloride API hinges on selecting reputable manufacturers with proven regulatory compliance, manufacturing capacity, and supply chain resilience. Leading global providers—ranging from large CMOs in China and India to specialized European and North American suppliers—offer diverse options, each with distinct advantages aligned to specific market requirements.

For pharmaceutical developers, an optimal sourcing strategy involves thorough supplier qualification, validation, and ongoing quality assessment to ensure uninterrupted supply of high-quality API essential for effective cardiovascular therapy.

---

Key Takeaways

• The rapidly evolving global API manufacturing landscape offers diverse sourcing options with varying regulatory compliance and cost structures.
• Prioritize suppliers with validated cGMP certifications, proven quality control, and regulatory approval histories.
• Asian manufacturers dominate volume capacity but require thorough vetting for regulatory compliance in Western markets.
• Diversify supply sources to mitigate risks associated with geopolitical, logistical, or quality issues.
• Maintain robust qualification and oversight processes to ensure consistent API quality and regulatory adherence.

---

FAQs

Q1: What are the primary regions for tirofiban hydrochloride API production?
A: The primary regions are Asia (China and India) for volume and cost advantages and Europe/North America for high-regulatory compliance and supply assurance.

Q2: How do I verify the quality of an API supplier?
A: Confirm their cGMP certification, review certification documents, request batch validation data, and examine their regulatory audit histories.

Q3: Are Asian API suppliers suitable for high-regulatory markets like the U.S. and EU?
A: Yes, many Asian suppliers comply with cGMP and possess relevant certifications, but supplier qualification and validation are critical to ensure compliance.

Q4: What factors influence API pricing and supply stability?
A: Manufacturing scale, raw material availability, regional geopolitical stability, regulatory compliance, and capacity management influence pricing and supply consistency.

Q5: How can drug developers mitigate risks associated with API supply disruptions?
A: By establishing qualification programs, qualifying multiple suppliers, maintaining adequate inventories, and engaging in long-term supply agreements.

---

Sources

[1] U.S. FDA Database of Approved APIs and Manufacturing Sites.
[2] European Medicines Agency (EMA) Certificate of Suitability and GMP Certificates.
[3] Industry reports on global API manufacturing capacities and market trends.
[4] Company websites and official documentation of major API suppliers.