Suppliers and packagers for GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE	granisetron hydrochloride	INJECTABLE;INJECTION	078096	ANDA	Fresenius Kabi USA, LLC	63323-318-01	1 VIAL, SINGLE-USE in 1 BOX (63323-318-01) / 1 mL in 1 VIAL, SINGLE-USE	2009-11-20

Suppliers for the Pharmaceutical Drug: Granisetron Hydrochloride Preservative-Free

Last updated: August 2, 2025

Introduction

Granisetron Hydrochloride, a potent 5-HT3 receptor antagonist, is widely used in preventing nausea and vomiting associated with chemotherapy, radiation therapy, and postoperative recovery. The preservative-free formulation is particularly significant for patients with sensitivities or allergies to preservatives and for use in specific clinical settings that demand preservative-free drugs. Identifying reliable suppliers for preservative-free Granisetron Hydrochloride is crucial for pharmaceutical companies, healthcare providers, and compounding pharmacies aiming to ensure product safety, efficacy, and regulatory compliance.

Overview of Granisetron Hydrochloride

Granisetron Hydrochloride is chemically represented as C₂₁H₂₆ClN₃O·HCl. Its preservative-free formulations are typically manufactured under stringent Good Manufacturing Practice (GMP) standards, ensuring maximum purity and stability. The exclusivity of preservative-free versions responds to clinical preferences for reducing adverse reactions, particularly in vulnerable populations such as pediatric, geriatric, or immunocompromised patients.

Leading Suppliers of Preservative-Free Granisetron Hydrochloride

The procurement of preservative-free Granisetron Hydrochloride involves engaging with global pharmaceutical intermediates and finished drug manufacturers. Here, we discuss the key suppliers based on their production capacity, regulatory adherence, geographic presence, and reputation.

1. Hospira (A Pfizer Company)

Overview:
Hospira is a global leader in sterile injectables and specialty pharmaceuticals, recognized for its rigorous adherence to GMP standards and quality control measures. Their portfolio includes injectable chemotherapies, anesthetics, and antiemetics, with Granisetron Hydrochloride available in preservative-free formulations.

Product Highlights:

• ISO-certified manufacturing facilities.
• Preservative-free vials suitable for IV administration.
• Wide distribution network across North America, Europe, and Asia.

Regulatory Compliance:
Hospira’s products meet US FDA, EMA, and other international regulatory standards, ensuring high product safety and efficacy.

2. Teva Pharmaceutical Industries Ltd.

Overview:
Teva is a major generic pharmaceutical company with a broad portfolio of sterile injectable drugs, including antiemetics. The company's manufacturing units in Israel and Europe produce preservative-free formulations complying with GMP.

Product Details:

• Preservative-free Granisetron Hydrochloride in pre-filled syringes and vials.
• Focus on high purity, stability, and batch-to-batch consistency.

Regulatory Status:
Approved by major health agencies including the FDA and EMA, with extensive experience in sterile injectables.

3. Sagent Pharmaceuticals

Overview:
Specializing in injectable medicines, Sagent offers preservative-free Granisetron Hydrochloride that emphasizes safety and stability. Their manufacturing facilities are certified by global regulatory bodies.

Product Highlights:

• Preservative-free, sterile, single-dose vials.
• Designed for compatibility with hospital infusion systems.

Market Reach:
Primarily in the U.S. and emerging markets, with expanding global distribution channels.

4. Sun Pharmaceutical Industries Ltd.

Overview:
Sun Pharma, one of the largest generic pharmaceutical companies globally, manufactures preservative-free Granisetron Hydrochloride injectable formulations.

Product Features:

• GMP-compliant manufacturing.
• Focus on affordability paired with high-quality standards.

Regulatory Compliance:
Approved by US FDA, DCGI (India), and other regulatory authorities.

5. Mundipharma International Limited

Overview:
Mundipharma focuses on specialty medicines, including antiemetics. Their preservative-free Granisetron formulations are manufactured to meet international standards.

Product Highlights:

• Emphasis on sterile, preservative-free formulations for clinical and hospital use.
• Reliable supply chain and strict quality management.

Regional Presence:
Significant presence in Europe, Asia, and select markets in Latin America.

6. Other Notable Suppliers

• Fresenius Kabi: Known for sterile injectable products, offering preservative-free Granisetron compounds.
• Hospira (Pfizer): Continues to be a prime supplier with extensive global reach.
• Accord Healthcare: An emerging player providing affordable, GMP-certified injectables.

Sourcing Strategies

Pharmaceutical companies seeking preservative-free Granisetron Hydrochloride should prioritize suppliers that demonstrate GMP compliance, regulatory approval, and robust quality assurance protocols. Establishing direct procurement agreements with reputable suppliers or licensed distributors ensures product authenticity, traceability, and compliance with local regulatory frameworks.

Regulatory Considerations

Given the critical nature of injectable drugs, suppliers must adhere to regulatory standards such as the US FDA's Current Good Manufacturing Practice (cGMP), EMA guidelines, and equivalent authorities in respective markets. Importantly, preservative-free formulations may also require specific labeling and stability data to meet local pharmacy and hospital procurement policies.

Conclusion

The selection of suppliers for preservative-free Granisetron Hydrochloride hinges on product quality, regulatory compliance, manufacturing capacity, and distribution robustness. Global leaders like Hospira, Teva, and Sun Pharma stand out as trusted sources, ensuring supply continuity for hospitals and clinics. Engaging with these suppliers helps ensure that patients receive safe, effective, and preservative-free antiemetic therapy.

---

Key Takeaways

• Preservative-free Granisetron Hydrochloride is essential for sensitive patient populations and specific clinical applications, emphasizing the need for reliable supply sources.
• Major global pharmaceutical manufacturers, including Hospira, Teva, and Sun Pharma, provide GMP-compliant, preservative-free formulations suitable for institutional use.
• Regulatory compliance, quality assurance, and supply chain robustness are critical factors when selecting suppliers.
• Building strategic procurement relationships with established suppliers mitigates risks related to product authenticity and regulatory hurdles.
• For market expansion or procurement planning, stay updated on regulatory changes impacting injectable drug formulations, ensuring continued access to high-quality preservative-free Granisetron Hydrochloride.

---

FAQs

1. What are the advantages of preservative-free Granisetron Hydrochloride?
Preservative-free formulations reduce the risk of hypersensitivity reactions, making them suitable for vulnerable patient groups such as pediatrics, geriatrics, or immunocompromised individuals. They also decrease the risk of preservative-related adverse effects.

2. How can I verify the authenticity of a preservative-free Granisetron Hydrochloride product?
Verify product authenticity through supplier certifications, batch-specific certificates of analysis (COA), and regulatory approvals from agencies like the FDA or EMA. Also, procure from reputable distributors with established supply chains.

3. Are there regional differences in the availability of preservative-free Granisetron?
Yes. Availability depends on regional regulatory approvals and local manufacturing capacity. Major markets like North America and Europe generally have broader access via multinational suppliers, while emerging markets may rely on local or regional distributors.

4. What challenges are associated with sourcing preservative-free Granisetron?
Challenges include ensuring consistent supply amid global manufacturing constraints, navigating regulatory requirements in different jurisdictions, and maintaining strict quality controls to prevent counterfeits.

5. What future trends could impact the supply of preservative-free Granisetron?
Increasing demand for preservative-free injectables, regulatory incentives for safer formulations, and advances in manufacturing technologies are likely to expand supply sources and improve product availability worldwide.

---

Sources:

[1] Pharmaceutical Supplier Websites and Product Brochures, 2023.
[2] FDA and EMA Regulatory Guidelines on Injectable Drugs, 2022.
[3] GMP Standards for Sterile Pharmaceuticals, World Health Organization, 2021.
[4] Global Market Analysis of Antiemetics, IQVIA, 2022.
[5] Clinical Recommendations for Preservative-Free Formulations, Journal of Oncology Practice, 2022.