Bulk Pharmaceutical API Sources for TICLID

Bulk Pharmaceutical API Sources for TICLID

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246558
NovoSeek		65335
MP Biomedicals		156922
MolPort		MolPort-003-666-728

Bulk Active Pharmaceutical Ingredient (API) Sources for Ticlid (Ticlopidine)

Last updated: July 27, 2025

Introduction

Ticlid (Ticlopidine) is an antiplatelet agent primarily used to reduce the risk of thrombotic stroke in patients with cerebrovascular disease. As a critical component in pharmaceutical formulations, the quality and supply of its active pharmaceutical ingredient (API) are vital for manufacturing efficacy, safety, and regulatory compliance. This article provides a comprehensive overview of bulk API sources for Ticlid, examining key manufacturers, geographic distribution, regulatory adherence, and emerging trends shaping the supply chain.

Overview of Ticlopidine API

Developed in the late 1970s and approved in various markets during the 1980s, Ticlid's synthesis involves complex chemical processes ensuring high purity standards. Given its clinical importance and relatively limited number of producers, securing reliable API sources remains a significant concern for pharmaceutical companies intending to manufacture or distribute generic or branded Ticlid.

Major API Manufacturers and Suppliers

1. International Pharmaceutical Companies

A. MGI Pharma (now part of Teva Pharmaceutical Industries)

• Profile: MGI Pharma historically manufactured Ticlopidine API, focusing on high-quality production aligned with Good Manufacturing Practices (GMP).
• Supply Status: Currently, MGI Pharma's API production has transitioned largely through its acquisition by Teva. Teva continues to produce Ticlopidine API, primarily for markets where it retains patent rights or market exclusivity.
• Regulatory Strength: Teva’s manufacturing facilities are compliant with international standards such as USFDA, EMA, and PIC/S, ensuring supply quality.

B. Teva Pharmaceutical Industries

• Profile: As one of the largest generic drug manufacturers globally, Teva supplies Ticlopidine API to various markets. It operates GMP-certified facilities in Israel, India, and Europe.
• Supply Chain: Teva’s diversified sourcing and large-scale manufacturing facilities make it a dominant supplier in the global API market for Ticlopidine.
• Regulatory Status: Products manufactured under rigorous quality controls, with extensive regulatory approvals.

C. Dr. Reddy’s Laboratories

• Profile: An Indian-origin supplier with GMP-certified manufacturing plants producing Ticlopidine API.
• Market Focus: Supplies API mainly to the Indian and emerging markets but increasingly expanding into developed regions.
• Quality Assurance: Compliant with USFDA, EMA, and WHO guidelines, although supplier verification remains essential for importers.

2. Asian API Manufacturers

A. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

• Profile: A leading Chinese API manufacturer with a growing portfolio, including Ticlopidine.
• Capabilities: Certified by Chinese GMP, with export licenses to multiple markets.
• Considerations: Quality standards require verification by importing companies, especially concerning comparability with international APIs.

B. Hetero Labs Limited (India)

• Profile: Known for a broad portfolio of generics, Hetero produces Ticlopidine API under GMP conditions.
• Regulatory Compliance: India’s regulatory framework (DCGI) closely aligns with WHO standards; however, verification per importing country’s regulations is recommended.

C. Zydus Cadila

• Profile: An Indian pharmaceutical firm producing a range of APIs, including Ticlopidine.
• Supply Focus: Regional and developing markets; international export capabilities increasing with WHO GMP certification.

3. Chemical Intermediates and Custom API Producers

Some specialty chemical firms offer custom synthesis of Ticlopidine API for large pharmaceutical companies or for research-use purposes.

Emerging Trends in API Sourcing for Ticlid

• Regional Diversification: To mitigate supply disruptions, pharmaceutical companies seek multiple sources across Asia, Eastern Europe, and Latin America.
• Manufacturing Consolidation: Larger firms acquire or partner with smaller API producers to ensure quality, cost-efficiency, and regulatory compliance.
• Regulatory Harmonization: Increased emphasis on compliance with international GMP standards, particularly USFDA and EMA, to facilitate global distribution.
• Supply Chain Transparency: Growing demand for traceability, batch verification, and anti-counterfeiting measures in API sourcing.

Regulatory Considerations

Purchasing Ticlopidine API from reputable, GMP-compliant suppliers is crucial. Regulatory authorities scrutinize API sources during product approval or inspection processes. Manufacturers must ensure that APIs conform to prescribed specifications, including purity, potency, and residual solvents. The international nature of API supply chains necessitates meticulous verification to prevent regulatory setbacks.

Challenges and Risks

• Supply Disruptions: Dependence on limited producers heightens vulnerability to shortages.
• Quality Variability: Differing standards between manufacturers could impact product safety and efficacy.
• Regulatory Non-Compliance: Suppliers lacking proper certification risk legal and financial repercussions.
• Price Volatility: Market dynamics, including raw material costs and geopolitical issues, influence API pricing.

Future Outlook

The API market for Ticlopidine is expected to consolidate further, with larger firms prioritizing quality and compliance. Increased demand for quality-assured APIs, especially from emerging markets, will incentivize suppliers to upgrade manufacturing standards. Additionally, advancements in chemical synthesis techniques could streamline production costs and improve supply stability.

Key Takeaways

• Major global API suppliers for Ticlid include Teva, Dr. Reddy's, Zydus Cadila, and Zhejiang Hisun.
• Ensuring GMP compliance and regulatory approval is essential in sourcing reliable Ticlopidine API.
• Asia remains the primary manufacturing hub, with India and China leading production capacity.
• Supply chain diversification and rigorous quality assurance mitigate risks associated with API sourcing.
• Regulatory oversight, traceability, and transparency are increasingly vital in API procurement strategies.

FAQs

1. What are the primary regions supplying Ticlopidine API globally?
The dominant regions include India and China, with additional sources in Israel, Europe, and the Americas, depending on regulatory compliance and production capacity.

2. How can pharmaceutical companies verify the quality of Ticlopidine API?
Verification involves reviewing manufacturer GAMP certificates, GMP certifications, batch testing reports, and prior regulatory compliance records.

3. Are there any upcoming regulatory changes affecting Ticlopidine API sourcing?
Regulations emphasizing GMP standards and supply chain transparency, such as USFDA's Drug Supply Chain Security Act (DSCSA), impact sourcing practices, requiring enhanced oversight.

4. Is regional diversification critical for Ticlopidine API supply?
Yes. Diversification mitigates risks linked to geopolitical issues, natural disasters, or manufacturing disruptions in specific regions.

5. What factors influence the pricing of Ticlopidine API?
Production costs, raw material prices, regulatory compliance costs, market demand, and geopolitical stability influence API pricing.

References

1. US Food and Drug Administration (FDA). Guidance for Industry: Active Pharmaceutical Ingredient (API) Quality Guidance.
2. World Health Organization (WHO). Technical Report Series: Good Manufacturing Practices for Pharmaceutical Products.
3. Teva Pharmaceutical Industries. API Manufacturing Capabilities.
4. Indian Pharmacopoeia Commission. Standards for Ticlopidine API.
5. Zhejiang Hisun Pharmaceutical Co., Ltd. Official Product Data Sheets.