Bulk Pharmaceutical API Sources for GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

Bulk Pharmaceutical API Sources for GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

Vendor	Vendor Homepage	Vendor Sku	API Url
BioChemPartner		BCP9000731
AstaTech, Inc.		45102
TCI (Tokyo Chemical Industry)		G0401

Bulk Active Pharmaceutical Ingredient (API) Sources for: Granisetron Hydrochloride Preservative-Free

Last updated: July 31, 2025

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Introduction

Granisetron hydrochloride is a selective 5-HT3 receptor antagonist widely used in clinical settings to prevent chemotherapy-induced nausea and vomiting (CINV), as well as postoperative nausea. The API's quality, purity, and supply chain integrity are critical for pharmaceutical manufacturers aiming to produce effective, preservative-free formulations. The procurement of high-quality bulk APIs involves identifying reputable suppliers, understanding their manufacturing standards, and evaluating their capacity to meet regulatory compliance. This article explores the key sources for bulk granisetron hydrochloride API, focusing specifically on preservative-free grades suitable for pharmaceutical use.

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Understanding Granisetron Hydrochloride API

Granisetron hydrochloride as an API is a potent compound requiring strict manufacturing controls under Good Manufacturing Practices (GMP). Given its application in intravenous and oral dosage forms, the API must be supplied in pharmaceutical-grade purity, with certifications confirming absence of preservatives, contaminants, and residual solvents.

The preservative-free requirement indicates that the API is produced and handled in environments that prevent contamination and avoid preservative agents, ensuring safety for sensitive patient populations.

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Major Global API Suppliers for Granisetron Hydrochloride

1. Shanghai Fosun Pharmaceutical (China)

Overview:
Fosun Pharma is one of China's leading pharmaceutical corporations with extensive experience in synthesizing and supplying APIs, including antiemetics like granisetron. Their facilities are GMP-certified, with robust quality control systems.

Strengths:

• Proven track record in API manufacturing for global markets
• GMP and ISO-certified facilities ensuring high-quality API production
• Capable of supplying preservative-free formulations suitable for injectable and oral medications

Considerations:

• Longer lead times due to geographic logistics
• Potential regulatory hurdles depending on target market standards

2. Zhejiang Hisoar Pharmaceutical (China)

Overview:
Hisoar specializes in the synthesis of serotonin antagonists, including granisetron, with manufacturing plants adhering to international regulatory standards.

Strengths:

• Advanced synthesis technologies ensuring high API purity
• Extensive documentation supporting preservative-free API batches
• Ability to customize particle size and formulation specifics

Considerations:

• Supply capacity may vary depending on demand

3. Sun Pharmaceutical Industries Ltd. (India)

Overview:
Sun Pharma is a global pharmaceutical leader known for producing high-quality APIs and intermediates, including formulations for antiemetics.

Strengths:

• Established GMP-compliant manufacturing facilities worldwide
• Verified for supplying preservative-free APIs suitable for sterile and non-sterile formulations
• Strong regulatory track record in key markets

Considerations:

• Potentially longer certification timelines for preservative-free specifications

4. Dr. Reddy’s Laboratories (India)

Overview:
Dr. Reddy's develops and supplies APIs with a focus on oncology and supportive care medicines, including antiemetics such as granisetron.

Strengths:

• Global GMP certification and strict quality controls
• Capable of providing preservative-free API batches
• Competitive pricing and reliable supply chain

Considerations:

• Focused primarily on large-scale production

5. Par Pharmaceutical (USA)

Overview:
Par Pharmaceutical offers comprehensive API sourcing services, including for specialized drugs like granisetron hydrochloride. Their facilities adhere to FDA and cGMP standards.

Strengths:

• USA-based manufacturing ensuring compliance with strict U.S. regulations
• Proven experience in supplying preservative-free APIs for sterile formulations
• Transparency in sourcing and batch certification

Considerations:

• Higher sourcing costs due to stringent GMP standards

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Key Aspects in Selecting API Suppliers for Preservative-Free Granisetron Hydrochloride

• Regulatory Compliance: Ensure suppliers hold current GMP, ISO, and other relevant certifications, with documentation supporting preservative-free status.
• Purity and Quality Standards: API should meet pharmacopeial standards (USP, EP, JP) with assay values typically exceeding 98%, low residual solvents, and absence of preservatives or stabilizers.
• Supply Chain Reliability: Consistent, scalable supply capacity, coupled with transparent logistics and quality assurance.
• Customization Options: Ability to modify particle size, form (powder, granular), and packaging suitable for injectable and oral formulations.
• Regulatory Support: Suppliers with experience in global regulatory submissions can facilitate faster market entry.

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Regional Focus and Market Trends

Asia-Pacific Region

Asia-Pacific remains the dominant source region for bulk APIs, owing to cost competitiveness, advanced manufacturing capabilities, and expanding production capacities. China and India are major players, with multiple validated productions of granisetron hydrochloride that meet international standards.

North America and Europe

In North America and Europe, demand for APIs like granisetron is driven by stringent regulatory oversight, with suppliers typically possessing advanced facilities backed by rigorous quality controls. U.S. and European suppliers often cater to premium markets requiring high regulatory assurance.

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Regulatory and Quality Considerations

When sourcing preservative-free API, manufacturers must ensure that suppliers provide comprehensive certificates of analysis (CoA), manufacturing process details, and stability data confirming preservative absence. Furthermore, documentation aligning with ICH guidelines, and regulatory pathways for generic or branded formulations, streamline approvals.

Manufacturers should evaluate suppliers against regulatory audits, past inspection history, and compliance with environmental standards that impact API quality.

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Emerging Trends and Future Outlook

Advancements in synthetic chemistry and continuous manufacturing techniques enhance the quality and stability of APIs such as granisetron hydrochloride. Increased regulatory scrutiny and demand for preservative-free products motivate suppliers to adopt innovative, environmentally sustainable manufacturing practices.

As biosimilar and generic markets expand, API suppliers investing in quality assurance and regulatory readiness will maintain competitive advantages.

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Key Takeaways

• The primary sources of preservative-free granisetron hydrochloride API are located mainly in China and India, with reputable suppliers like Fosun Pharma, Hisoar, Sun Pharma, and Dr. Reddy’s Laboratories.
• Strict adherence to GMP and pharmacopoeial standards is essential to ensure API purity, efficacy, and safety for preservative-free formulations.
• Suppliers with verified regulatory certifications, transparent quality documentation, and proven supply stability are preferred for high assurance.
• Collaboration with suppliers capable of customizing API physical and chemical characteristics enhances formulation development.
• The regulatory landscape is evolving, emphasizing the importance of detailed documentation and compliance to ensure successful global market entry.

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FAQs

1. Is preservative-free granisetron hydrochloride API readily available?
Yes, multiple reputable suppliers, primarily in Asia, offer preservative-free granisetron hydrochloride API, adhering to strict regulatory and quality standards suitable for pharmaceutical manufacturing.

2. What should I consider when choosing an API supplier for preservative-free grades?
Prioritize suppliers with GMP certification, detailed quality documentation, capacity for large-scale production, and proven compliance with regulatory standards. Also, evaluate their ability to provide customized formulations and stability data supporting preservative absence.

3. Do Asian suppliers meet international quality standards for APIs?
Many Asian manufacturers, particularly in China and India, produce APIs that meet international standards such as USP, EP, and JP, and are compliant with GMP certifications necessary for global pharmaceutical markets.

4. How do regulatory requirements impact API sourcing for preservative-free drugs?
Regulatory agencies require comprehensive documentation confirming preservative-free status, impurity profiles, residual solvent levels, and batch certification. Suppliers with robust documentation and past regulatory compliance streamline this process.

5. What trends are shaping the future API supply chain for granisetron hydrochloride?
Innovations in synthetic methods, increased emphasis on preservative-free formulations, and stricter regulatory standards are driving suppliers to adopt advanced manufacturing techniques, improve quality assurance, and expand capacity to meet global demand.

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Sources

[1] U.S. Pharmacopeia (USP) standards for granisetron hydrochloride API.
[2] European Pharmacopoeia (EP) monograph on antiemetic APIs.
[3] Industry reports on global API manufacturing capacities, 2023.
[4] Regulated suppliers' certification disclosures and official GMP audit reports.
[5] Market trend analyses from industry research firms (e.g., IQVIA, EvaluatePharma).