Suppliers and packagers for generic pharmaceutical drug: GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eugia Pharma	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	204238	ANDA	Eugia US LLC	55150-175-01	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-175-01) / 1 mL in 1 VIAL, SINGLE-DOSE	2016-07-06
Eugia Pharma	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	204238	ANDA	Eugia US LLC	55150-176-04	1 VIAL, MULTI-DOSE in 1 CARTON (55150-176-04) / 4 mL in 1 VIAL, MULTI-DOSE	2016-07-06
Hikma Farmaceutica	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078629	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9744-10	10 VIAL, SINGLE-USE in 1 PACKAGE (0143-9744-10) / 1 mL in 1 VIAL, SINGLE-USE (0143-9744-01)	2009-12-23
Hikma Farmaceutica	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078629	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9745-05	5 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-05) / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01)	2009-12-23
Hikma Farmaceutica	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078629	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9745-10	10 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-10) / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01)	2009-12-23
Mylan Asi	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	091136	ANDA	Mylan Institutional LLC	67457-863-01	1 VIAL in 1 CARTON (67457-863-01) / 1 mL in 1 VIAL	2018-03-21

Granisetron Hydrochloride: Global Supplier Landscape Analysis

Last updated: February 19, 2026

This report analyzes the global supplier landscape for granisetron hydrochloride, a selective 5-HT3 receptor antagonist used to prevent chemotherapy-induced nausea and vomiting. The analysis focuses on active pharmaceutical ingredient (API) manufacturers, their production capacities, regulatory compliance, and market positioning to inform strategic sourcing and investment decisions.

Who Are the Key API Manufacturers for Granisetron Hydrochloride?

The production of granisetron hydrochloride API is concentrated among a limited number of global manufacturers. These companies possess the technical expertise and regulatory approvals to supply the highly purified drug substance required for finished pharmaceutical products.

• Orchid Chemicals & Pharmaceuticals Ltd.: A significant player in the API market, Orchid Chemicals has been involved in the production of granisetron hydrochloride. The company has a history of API manufacturing and export.
• Teva Pharmaceutical Industries Ltd.: As a major generic pharmaceutical company, Teva is known for its broad API portfolio. Their involvement in granisetron hydrochloride production positions them as a key supplier.
• Sun Pharmaceutical Industries Ltd.: Another leading Indian generic pharmaceutical company, Sun Pharma is a prominent manufacturer of APIs, including those for oncology support.
• Laurus Labs Limited: This Indian API manufacturer has expanded its production capabilities across various therapeutic areas and is a notable supplier in the global market.
• Ajanta Pharma Limited: Ajanta Pharma produces a range of APIs and finished dosage forms, with granisetron hydrochloride being part of their offerings.

These manufacturers are characterized by their robust quality management systems and adherence to Good Manufacturing Practices (GMP). Their ability to produce at scale and meet stringent regulatory requirements is critical for the consistent supply of granisetron hydrochloride to the global pharmaceutical market.

What Are the Production Capacities and Geographic Distribution of Suppliers?

Precise, publicly disclosed production capacities for specific APIs like granisetron hydrochloride are often proprietary. However, the general trend indicates significant manufacturing presence in India and, to a lesser extent, Europe and other Asian countries.

• India: Dominates API manufacturing due to its cost-competitive environment, skilled workforce, and established pharmaceutical infrastructure. Companies like Sun Pharma, Laurus Labs, and Ajanta Pharma have substantial API production capabilities that can support global demand for granisetron hydrochloride.
• Europe: Some European manufacturers also produce APIs, often focusing on niche markets or specialized therapeutic areas. While less dominant in volume compared to India, European suppliers are known for high-quality standards and regulatory compliance, particularly for markets with strict oversight.
• Other Asian Countries: Countries like China also contribute to API manufacturing, although the focus on granisetron hydrochloride from Chinese suppliers may be less prominent compared to Indian counterparts for regulated markets.

The geographic concentration in India allows for economies of scale, but also presents supply chain risks. Diversification of sourcing across different regions is a strategic consideration for pharmaceutical companies.

What Regulatory Approvals Do Key Suppliers Hold?

Suppliers of granisetron hydrochloride API must obtain regulatory approvals from major health authorities to supply drugs to regulated markets such as the United States, Europe, and Japan. Key approvals include:

• US Food and Drug Administration (FDA) approval: Manufacturers seeking to supply granisetron hydrochloride API to the U.S. market must have their manufacturing facilities inspected and approved by the FDA. This often involves the submission of a Drug Master File (DMF).

• European Directorate for the Quality of Medicines & HealthCare (EDQM) Certificate of Suitability (CEP): For the European market, a CEP demonstrates that the API complies with the European Pharmacopoeia monograph.

• Other National Regulatory Authorities: Approvals from agencies like Japan's Pharmaceuticals and Medical Devices Agency (PMDA) are also critical for market access in those regions.

• Orchid Chemicals & Pharmaceuticals Ltd.: Has historically held approvals from various regulatory bodies, including potential FDA filings.

• Teva Pharmaceutical Industries Ltd.: As a global player, Teva’s facilities are routinely inspected and approved by major regulatory agencies worldwide, facilitating API supply for their granisetron hydrochloride products.

• Sun Pharmaceutical Industries Ltd.: Holds numerous DMFs and CEPs for its APIs, supporting its global market presence, including for granisetron hydrochloride.

• Laurus Labs Limited: Actively seeks and maintains regulatory approvals from FDA, EDQM, and other international authorities for its API portfolio.

• Ajanta Pharma Limited: Reports compliance with international quality standards and has facilities approved by regulatory bodies relevant to its export markets.

The presence of an active DMF or CEP is a strong indicator of a supplier's readiness to supply regulated markets.

What Are the Quality Standards and Analytical Specifications for Granisetron Hydrochloride API?

Granisetron hydrochloride API must meet stringent quality standards defined by pharmacopoeias and regulatory authorities to ensure the safety and efficacy of the final drug product.

• Pharmacopoeial Monographs: The primary specifications are typically defined in monographs from:

  • United States Pharmacopeia (USP): Sets limits for identification, assay, related substances, residual solvents, and other impurities.
  • European Pharmacopoeia (Ph. Eur.): Similar to USP, with specific tests and acceptance criteria.
  • Japanese Pharmacopoeia (JP): Provides a Japanese perspective on quality standards.

• Key Quality Parameters:

  • Assay: Typically 98.0% to 102.0% of granisetron hydrochloride on a dried basis.
  • Related Substances/Impurities: Strict limits on process-related impurities and degradation products. Specific impurities are identified and quantified (e.g., isomers, starting material residues).
  • Residual Solvents: Adherence to ICH Q3C guidelines for solvents used in manufacturing.
  • Water Content: Usually determined by Karl Fischer titration, with specified limits.
  • Heavy Metals: Compliance with pharmacopoeial limits.
  • Particle Size Distribution: May be specified depending on the requirements of the finished dosage form manufacturing process (e.g., for tablet compression or capsule filling).

Suppliers are expected to provide a Certificate of Analysis (CoA) with each batch, detailing the results of all specified tests against the pharmacopoeial and customer-defined specifications.

What Are the Market Dynamics and Competitive Landscape?

The market for granisetron hydrochloride API is characterized by a competitive landscape driven by generic competition.

• Genericization: Granisetron hydrochloride is an established drug, and its patent expiries have led to the availability of generic versions. This drives demand for cost-effective API sourcing.
• Price Sensitivity: Pharmaceutical companies manufacturing finished dosage forms are highly sensitive to API pricing due to the competitive nature of the generic market.
• Supplier Consolidation: While multiple suppliers exist, there can be a degree of consolidation among major global API producers who can achieve economies of scale and meet diverse regulatory requirements.
• Supply Chain Resilience: Recent global events have highlighted the importance of supply chain resilience. Pharmaceutical companies are increasingly looking for suppliers with robust business continuity plans and diversified manufacturing footprints.
• New Entrants: While the market is mature, new API manufacturers with advanced capabilities and cost advantages can emerge, particularly from regions with growing pharmaceutical sectors.

The competitive advantage for API suppliers lies in their ability to offer high-quality products at competitive prices, coupled with reliable supply and strong regulatory support.

What Are the Future Trends and Potential Challenges?

The future supply of granisetron hydrochloride API will be shaped by several factors:

• Increasing Demand for Oncology Support: The aging global population and advancements in cancer treatment are expected to drive continued demand for antiemetic drugs like granisetron hydrochloride.
• Biosimil Competition: While granisetron hydrochloride is a small molecule, the broader trend of biosimil development in oncology may indirectly influence market dynamics and pricing pressures for supportive care medications.
• Regulatory Scrutiny: Regulatory authorities continue to enhance their oversight of API manufacturing. Suppliers must maintain impeccable quality systems and proactively adapt to evolving guidelines.
• Geopolitical Risks and Trade Policies: Global trade tensions and geopolitical instability can impact the cost and availability of raw materials and finished APIs, necessitating robust supply chain risk management.
• Technological Advancements in Manufacturing: Adoption of advanced manufacturing technologies, such as continuous manufacturing, could offer efficiency gains and cost reductions for API producers.
• Sustainability Initiatives: Growing pressure for sustainable manufacturing practices may lead to increased demand for APIs produced with lower environmental impact, requiring suppliers to invest in greener processes.

Challenges include managing fluctuating raw material costs, maintaining consistent quality across diverse production sites, and navigating complex international regulatory frameworks.

Key Takeaways

• The granisetron hydrochloride API market is primarily served by manufacturers in India, with significant players including Orchid Chemicals, Teva, Sun Pharma, Laurus Labs, and Ajanta Pharma.
• Regulatory compliance, particularly FDA and EDQM approvals, is essential for suppliers targeting major pharmaceutical markets.
• API quality is governed by strict pharmacopoeial standards (USP, Ph. Eur., JP) with precise specifications for assay, impurities, and residual solvents.
• The market is characterized by generic competition, leading to price sensitivity and a strong emphasis on cost-effective, reliable sourcing.
• Future demand is expected to grow, driven by oncology support needs, but challenges include regulatory evolution, geopolitical risks, and the drive for manufacturing sustainability.

Frequently Asked Questions

1. Which suppliers are best positioned to meet stringent US FDA requirements for granisetron hydrochloride API? Suppliers that maintain active US DMFs and have a history of successful FDA inspections are best positioned. Teva Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries Ltd., with their global regulatory expertise, are strong candidates.

2. What are the typical lead times for API orders of granisetron hydrochloride from major Indian manufacturers? Lead times can vary but generally range from 8 to 16 weeks for standard API orders, depending on production schedules and existing inventory. Urgent or large-volume orders may require longer lead times.

3. Are there any single-source risks associated with granisetron hydrochloride API supply? While multiple manufacturers exist, reliance on a single supplier can create risk. Pharmaceutical companies often qualify at least two to three suppliers from different geographic regions to mitigate this.

4. What is the impact of raw material price volatility on granisetron hydrochloride API costs? The cost of key starting materials and intermediates can fluctuate significantly due to supply/demand dynamics, geopolitical events, and environmental regulations, directly impacting the final API price.

5. How does the patent status of granisetron hydrochloride affect the API market? As granisetron hydrochloride is off-patent, the API market is dominated by generic manufacturers. This fosters competition among API suppliers, driving down prices and emphasizing efficiency and volume.

Citations

[1] United States Pharmacopeia. (n.d.). Granisetron Hydrochloride Monograph. [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability (CEP). [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2018). ICH Harmonised Tripartite Guideline Impurities: Guideline for Residual Solvents Q3C(R7). [4] Pharmaceutical Technology. (2023). API Manufacturing Landscape. [5] Market research reports on the global API market (specific reports vary and are proprietary, influencing general market observations).