Bulk Pharmaceutical API Sources for SUSTOL

Bulk Pharmaceutical API Sources for SUSTOL

Vendor	Vendor Homepage	Vendor Sku	API Url
AstaTech, Inc.		45100
AKos Consulting & Solutions		AKOS025402424
Clearsynth		CS-O-30593
Hangzhou APIChem Technology		AC-8910
OChem		8407
Yuhao Chemical		LT1163
MuseChem		M026808

Bulk Active Pharmaceutical Ingredient (API) Sources for Sustol (Granisetron Injection)

Last updated: July 28, 2025

Introduction

Sustol, the brand name for granisetron extended-release injection, is a pharmaceutical used to prevent nausea and vomiting caused by chemotherapy. As a critical component, the active pharmaceutical ingredient (API) — granisetron — must be sourced reliably and in compliance with regulatory standards. The global supply chain for APIs has become increasingly complex, demanding robust sourcing strategies to ensure quality, cost-efficiency, and regulatory adherence. This article examines the primary sources of bulk granisetron API for Sustol, analyzing the key manufacturers, geographical considerations, regulatory environments, and supply chain dynamics influencing API sourcing.

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Understanding Granisetron API

Granisetron belongs to the class of serotonin 5-HT3 receptor antagonists. Its synthesis involves complex chemical processes requiring specialized manufacturing capabilities. The API must meet stringent quality standards, including purity, potency, and stability, as set by regulatory agencies like the FDA, EMA, and other authorities.

Major API Manufacturers for Granisetron

The procurement of granisetron API for Sustol typically involves a limited number of high-quality, validated suppliers globally. These manufacturers are distinguished by their manufacturing capacity, regulatory compliance, and proven quality assurance systems.

1. Pharma-grade API Manufacturers

a. Teva Pharmaceutical Industries Ltd.

Teva is a leading global pharmaceutical company with a significant footprint in API manufacturing, including granisetron. Their API facilities in Israel and India have been approved by major regulatory bodies, ensuring adherence to Good Manufacturing Practices (GMP). Teva’s API hub offers reliable sourcing, backed by rigorous quality control protocols ([1]).

b. CIPLA Ltd.

CIPLA, based in India, is a prominent API manufacturer specializing in a broad spectrum of active pharmaceutical ingredients, including granisetron. Their facilities in India possess multiple certifications from WHO-GMP and other regulatory agencies, making them a trustworthy supplier for global markets ([2]).

c. Sun Pharmaceutical Industries Ltd.

Sun Pharma operates API manufacturing plants approved by global regulators. They produce granisetron API with consistent quality and supply reliability, leveraging their extensive R&D and manufacturing infrastructure in India ([3]).

d. Mylan N.V. (Now part of Viatris)

Viatris, formed from Mylan's merger, maintains API manufacturing facilities, including those producing granisetron, with regulatory clearances supporting global distribution. Their strategic supply chain ensures continuity and quality assurance.

e. Sagent Pharmaceuticals

Specialized in injectable APIs, Sagent Pharma manufactures granisetron API with stringent quality controls suitable for injectable formulations like Sustol. Their focus on sterile and injectable APIs enhances their reputation for quality.

2. Contract Manufacturing Organizations (CMOs)

Several CMOs globally produce granisetron API under strict contract arrangements, enabling pharmaceutical companies to secure demand without significant capital investment.

a. WuXi AppTec

WuXi offers comprehensive CMO services with GMP-validated facilities in China. Their API manufacturing includes granisetron, with a focus on quality, scalability, and regulatory compliance.

b. Zhejiang Huahai Pharmaceutical Co., Ltd.

Known for sterile and non-sterile APIs, Huahai provides reliable manufacturing of granisetron API for global clients, complying with international standards.

c. Jiangsu Hengrui Medicine Co., Ltd.

This Chinese manufacturer supplies high-quality APIs, including granisetron, with multiple regulatory approvals supporting export and global distribution.

Geographical and Regulatory Considerations

Primarily, API manufacturing centers for granisetron are located in India and China—countries with robust pharmaceutical manufacturing sectors and significant export capacity. Indian API producers benefit from extensive GMP certifications, WHO-GMP compliance, and cost advantages; Chinese manufacturers leverage scale, infrastructure, and growing regulatory acceptance.

Regulatory recognition varies:

• India: Numerous APIs, including granisetron, are manufactured under WHO-GMP and inspected by the US FDA, EMA, and other agencies, enabling broad distribution.

• China: Increasingly rigorous regulatory oversight has improved API quality standards, with certifications like GMP and approvals from major regulators.

The selection of API sources must consider the regulatory landscape of the end markets, ensuring suppliers are compliant with the destination country’s standards.

Supply Chain Dynamics and Risk Management

The API supply chain for granisetron involves factors such as manufacturing capacity, geopolitical stability, quality assurance, and logistics. The global political climate, especially US-China trade relations, influences sourcing decisions.

• Diversification: Companies often diversify suppliers across geographies to mitigate risks of supply disruptions.

• Quality Assurance: Quality agreements, audits, and validation batches are critical for maintaining standards and regulatory compliance.

• Cost and Lead Time: Cost-effective manufacturing in India and China is attractive, but harmonized regulatory oversight and logistical considerations are critical.

Key Challenges in API Sourcing for Sustol

• Regulatory hurdles: Suppliers must meet stringent quality standards and demonstrate GMP compliance, especially for injectable APIs.

• Supply Security: Capacity limitations or geopolitical issues may lead to shortages or delays.

• Quality Variability: Some suppliers may face challenges maintaining consistent quality, impacting regulatory approvals and patient safety.

• Pricing pressures: Market competition influences API pricing, but quality and regulatory compliance remain paramount.

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Conclusion

Sourcing bulk granisetron API for Sustol involves navigating a concentrated but diverse landscape comprising prominent Indian and Chinese manufacturers, supplemented by specialized CMOs. Ensuring consistent quality, regulatory compliance, and supply chain resilience is critical for pharmaceutical companies aiming to produce Sustol reliably.

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Key Takeaways

• The primary global suppliers of granisetron API include Teva, CIPLA, Sun Pharma, Mylan (Viatris), and Sagent Pharmaceuticals, mostly based in India and China.

• Indian manufacturers benefit from WHO-GMP certifications and cost advantages, while Chinese suppliers are improving regulatory standards and capacity.

• Diversification of API sources minimizes supply risks and ensures regulatory compliance across different markets.

• Strategic supplier engagement, rigorous quality audits, and maintaining regulatory certifications are essential to mitigate supply chain disruptions.

• The evolving regulatory landscape necessitates due diligence, especially for injectable APIs like granisetron.

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FAQs

1. What are the main qualities to consider when sourcing granisetron API for Sustol?
Quality attributes include high purity (typically >98%), consistent potency, minimal impurities, GMP compliance, and stability suitable for injectable formulations.

2. Why is India a significant source of granisetron API?
India hosts many GMP-certified API manufacturers with extensive export experience, cost advantages, and a proven track record of quality and regulatory compliance.

3. How does regulatory compliance impact API sourcing decisions?
Regulatory approval ensures that APIs meet safety, efficacy, and quality standards, which is essential for product registration and market acceptance in developed regions like the US and EU.

4. What risk mitigation strategies do companies use in sourcing APIs like granisetron?
Diversification across multiple suppliers and geographies, conducting regular audits, maintaining qualification protocols, and establishing long-term contracts mitigate supply chain disruptions.

5. Are there domestic sources of granisetron API in the United States?
Currently, granisetron API manufacturing is predominantly based in India and China. The U.S. relies on imported APIs, with an increasing emphasis on establishing domestic capacity or reliable overseas supply chains with strong regulatory oversight.

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References

[1] Teva Pharmaceuticals, API Manufacturing Capabilities, 2022.
[2] CIPLA Ltd. API Portfolio Overview, 2022.
[3] Sun Pharmaceutical Industries, Annual Report, 2022.