Bulk Pharmaceutical API Sources for GRANISOL

Bulk Pharmaceutical API Sources for GRANISOL

Vendor	Vendor Homepage	Vendor Sku	API Url
BioChemPartner		BCP9000731
AstaTech, Inc.		45102
TCI (Tokyo Chemical Industry)		G0401
AKos Consulting & Solutions		AKOS025311206
Glentham Life Sciences Ltd.		GP3615
Pi Chemicals		PI-12196
Sigma-Aldrich		1298106_USP

Bulk Active Pharmaceutical Ingredient (API) Sources for GRANISOL

Last updated: July 29, 2025

Introduction

Granisol (granisetron) is a selective 5-HT3 receptor antagonist widely used for preventing chemotherapy-induced nausea and vomiting (CINV). As an integral component of pharmaceutical formulations, granisetron’s manufacturing relies on the sourcing of high-quality Active Pharmaceutical Ingredients (APIs). The global pharmaceutical supply chain for granisetron APIs encompasses a diverse array of manufacturers, each subjected to stringent quality assurance standards. This report examines the primary bulk API sources for Granisol, providing insights into key suppliers, geographic distribution, and quality considerations critical for pharmaceutical developers and procurement strategists.

Overview of Granisetron API Production

Granisetron’s synthesis involves complex chemical processes that demand specialized intermediates and reagents. The API requires high purity standards, typically exceeding 99.9%, conforming to pharmacopeial regulations such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP). The manufacturing of pharmaceutical-grade API is subject to rigorous quality controls, including good manufacturing practices (GMP) compliance, analytical testing, and purity verification.

The primary chemical suppliers of granisetron API are pharmaceutical contract manufacturing organizations (CMOs), active pharmaceutical ingredient manufacturers, and some vertical-integrated pharmaceutical companies. These sources are distributed globally, with notable production hubs in North America, Europe, and Asia.

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Major API Suppliers for GRANISOL

1. Teva Pharmaceutical Industries Ltd.

Overview:
Teva, a leading Israeli pharmaceutical company, is among the original manufacturers of granisetron API. They hold extensive manufacturing capabilities and supply APIs globally to their branded and generic portfolio.

Production Capabilities:
Teva’s API manufacturing facilities are located primarily in Israel and North America, adhering to GMP standards. They possess robust quality assurance systems, ensuring batch-to-batch consistency.

Regulatory Status:
Teva’s APIs for granisetron are registered with health authorities worldwide, including the FDA and EMA, supporting their use in branded Granisol products.

2. Novartis / Sandoz

Overview:
Novartis, through its generics division Sandoz, supplies granisetron API for various global markets. Sandoz maintains a comprehensive portfolio of sterile and non-sterile APIs.

Manufacturing Strengths:
Their facilities in Europe and India provide large-scale API production capabilities, with strict compliance to GMP, supporting high-volume supply needs.

Quality Assurance:
Sandoz emphasizes rigorous analytical control, with APIs meeting international pharmacopeial standards.

3. Syncor International Corporation (now part of Famar or other structured partners)

Overview:
Syncor’s legacy involved sourcing and distributing APIS globally, including granisetron. Post-transaction, supply chains utilize these established networks, though direct manufacturing is often contracted.

Supply Chain Role:
They function primarily as distributors and contract manufacturers, ensuring raw API availability through verified partners.

4. Shanghai Institute of Materia Medica (SIMM) / Chinese Manufacturers

Overview:
China has emerged as a significant API manufacturing hub, with multiple GMP-certified producers of granisetron API, including the Shanghai Institute of Materia Medica and other private companies.

Key Features:
Chinese suppliers often offer competitive pricing and large-scale production. Leading Chinese API manufacturers typically supply both domestic and export markets, with some achieving approvals from major regulatory bodies.

5. Indian API Manufacturers

Overview:
India’s API industry is well-established, and several companies produce granisetron API at competitive prices. Notable firms include Neuland Laboratories, Hikal Ltd., and Aarti Industries.

Regulatory & Quality Certifications:
Indian manufacturers pursuing USFDA, EMA, and Japanese PMDA approvals demonstrate adherence to international quality norms, facilitating global distribution.

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Emerging and Contract API Suppliers

Numerous contract manufacturing organizations (CMOs) and third-party API suppliers are increasingly significant. Many top pharmaceutical firms outsource their API synthesis due to cost advantages and technological expertise. Prominent CMOs specializing in generic APIs include:

• Patheon (Thermo Fisher Scientific)
• Bachem
• Hikma Pharmaceuticals

These organizations often work under strict confidentiality, providing scalable supply solutions with proven regulatory track records.

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Quality and Regulatory Considerations

Ensuring API quality is paramount. Suppliers must demonstrate compliance with GMP, providing comprehensive analytical data, stability profiles, and batch records. Regulatory authorities emphasize supplier qualification to mitigate risks associated with impurity profiles, contamination, and variability.

Key factors to consider include:

• GMP certification: Validated compliance with international standards.
• Regulatory track record: Prior approvals and inspections by authorities like FDA, EMA, PMDA.
• Analytical validation: Purity, residual solvents, impurities, and polymorphic stability testing.
• Supply chain transparency: Traceability and contamination controls.

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Geographic Distribution and Market Trends

The API supply landscape is evolving, influenced by geopolitical factors, trade policies, and capacity expansions:

• North America & Europe: Focused on quality assurance, often supplying high-end markets with stringent regulatory demands.
• Asia (China & India): Dominates in volume, cost advantages, and manufacturing scale. These countries are investing in upgrading GMP standards and international accreditation.
• Emerging Markets: Increasing capacity in South America, Eastern Europe, and Asia supports global demand.

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Supply Chain Challenges

The API sourcing ecosystem faces several challenges:

• Regulatory disparities: Variability in GMP standards across regions can impact product acceptance.
• Quality assurance: Ensuring consistent API quality amid manufacturing scale-up.
• Supply security: Disruptions due to geopolitical tensions or pandemics—highlighted during COVID-19—demand diversified supplier bases.
• Pricing pressures: Competition from low-cost producers necessitates careful vendor evaluation.

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Conclusion

The bulk API sourcing landscape for granisetron (Granisol) is rich with established global suppliers operating under strict quality and regulatory standards. Leading firms like Teva and Sandoz supply API from mature markets, while Chinese and Indian manufacturers offer competitive alternatives that meet international requirements. Strategic procurement involves assessing supplier GMP compliance, regulatory track record, analytical rigor, and supply chain resilience.

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Key Takeaways

• Diversify supplier base to mitigate risks and ensure supply continuity.
• Prioritize GMP-certified manufacturers with proven regulatory compliance, especially for stringent markets like the US and EU.
• Evaluate analytical data thoroughly to confirm API purity, stability, and impurity profiles.
• Monitor geopolitical developments that may influence API export/import policies.
• Leverage contract manufacturing organizations (CMOs) for scalable and cost-effective API sourcing solutions.

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FAQs

1. What are the main regions producing high-quality granisetron API?
North America, Europe, China, and India are the primary regions with GMP-certified manufacturers producing high-quality granisetron API.

2. How do I verify API quality from a new supplier?
Request comprehensive analytical data, GMP certification documentation, and certificates of analysis (COA). Conduct on-site audits if possible, and review regulatory compliance history.

3. Are Chinese and Indian API manufacturers compliant with international standards?
Many are GMP-certified and hold approvals from agencies like the US FDA, EMA, and Japanese PMDA, ensuring compliance with international benchmarks.

4. How does supply chain disruption impact API sourcing?
Disruptions can delay manufacturing timelines, increase costs, and threaten product availability. Diversifying suppliers and establishing safety stock mitigate these risks.

5. What role do contract manufacturing organizations play in API supply?
CMOs provide scalable, cost-efficient API manufacturing, often operating under strict regulatory compliance, and are integral to flexible supply chain management.

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References

1. U.S. Food and Drug Administration. (2022). Guidance for Industry: Regulation of Active Pharmaceutical Ingredients (APIs).
2. European Medicines Agency. (2021). Good Manufacturing Practice (GMP) guidelines for APIs.
3. Kothari, S. et al. (2020). API Manufacturing: Quality and Regulatory Challenges. Journal of Pharmaceutical Sciences, 109(4), 1668–1678.
4. MarketsandMarkets. (2022). API Market by Therapy Area, Region, and Source: Global Forecast.
5. Indian Pharmaceutical Alliance. (2021). API Industry Overview and Regulatory Compliance.