granisetron: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cumberland	SANCUSO	granisetron	FILM, EXTENDED RELEASE;TRANSDERMAL	022198	NDA	Cumberland Pharmaceuticals Inc.	66220-637-31	168 h in 1 POUCH (66220-637-31)	2024-07-16
Cumberland	SANCUSO	granisetron	FILM, EXTENDED RELEASE;TRANSDERMAL	022198	NDA	Cumberland Pharmaceuticals Inc.	66220-637-72	168 h in 1 POUCH (66220-637-72)	2024-07-16
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445	NDA	Heron Therapeutics, Inc.	47426-101-06	6 KIT in 1 CARTON (47426-101-06) / 1 SYRINGE, GLASS in 1 KIT / .4 mL in 1 SYRINGE, GLASS	2016-08-09
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Granisetron suppliers: API and finished-dose manufacturers, contract manufacturers, and key market players

Granisetron supply is split across (1) sterile finished-dose manufacturers (injection and infusion), (2) solid-dose manufacturers (tablets), and (3) active pharmaceutical ingredient (API) producers. The supplier landscape is also shaped by patent and data exclusivity regimes that affect who can enter with generics and biosimilar-equivalent products (granisetron is small-molecule; biosimilar routing does not apply).

High-level procurement map

Finished drug (injection/infusion): typically produced in compliance with sterile manufacturing, terminal sterilization or aseptic processing, and packaging for hospitals and oncology infusion centers.
Finished drug (tablets): solid-dose GMP with controlled dissolution profiles and stability for antiemetic use.
API (granisetron hydrochloride and/or granisetron free base depending on salt form and site capabilities): supplied to finished-dose makers via qualified intermediates and validated synthetic routes.

Who manufactures granisetron injection and infusion (finished-dose) and supplies hospitals?

Granisetron injection is a sterile product used for chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV). The finished-dose supplier set depends on the branded originator and subsequent generic manufacturers in each market.

Key finished-dose supplier archetypes

Originator/brand holders and their authorized manufacturers: produce for the branded pipeline and supply contracts.
US/EU generic sterile manufacturers: supply multisource alternatives where regulatory approvals exist.
Contract development and manufacturing organizations (CDMOs): provide sterile fill-finish and labeling services for multiple entrants, often with shared upstream API qualification.

Common distribution channels

Hospital and group purchasing organization (GPO) contracts
Wholesaler distribution
Specialty oncology procurement

What usually differentiates sterile suppliers

Sterile facility inspection record (FDA/EU)
Batch record controls for aseptic/terminal processes
Container closure systems (vials, prefilled syringes, infusion bags)
Labeling and barcoding (UDI readiness for the US)

Which companies supply granisetron tablets (solid-dose) to pharmacies and distributors?

Solid-dose granisetron supports ambulatory and outpatient CINV/PONV use. Tablet supply is dominated by generic solid-dose manufacturers and some brand-aligned suppliers.

Solid-dose supplier criteria that drive selection

Bioequivalence outcomes and dissolution matching
Stability and packaging formats (blister vs bottle)
Scale and ability to support tender schedules
Regulatory inspection outcomes

Typical product variants in procurement

Strengths vary by country and labeling (often 1 mg and 2 mg tablet strengths in major markets).
Packaging formats differ by health system requirements.

Which firms produce granisetron API and granisetron hydrochloride for contract manufacturing?

API suppliers provide granisetron (often as granisetron hydrochloride) to finished-dose manufacturers.

API supply chain structure

API synthesis and isolation: development and scale-up of chemical intermediates, crystallization, salt formation.
Quality systems: DMF-supported quality packages in the jurisdictions where required.
Regulatory filings: API site eligibility for reference-listed drug supply chains.

What procurement teams typically verify for API

CoA coverage for critical impurities and residual solvents
Particle size and polymorph control for consistency
Endotoxin status if relevant to downstream sterile manufacturing interface
Change control records and comparability protocol execution

How do FDA and EMA approvals determine who can supply granisetron generics?

Granisetron is regulated under standard small-molecule chemical drug frameworks. Entry with generics depends on FDA approvals (US) and marketing authorizations (EU) and is supported by data packages showing sameness to the reference listed drug in the relevant strengths and dosage forms.

US regulatory entry mechanism

FDA approvals for ANDAs and 505(b)(2) pathways for generics and supplemental approvals.
Orange Book listings control which applicants can rely on reference and which patents are listed.

EU regulatory entry mechanism

National procedures and centralized approvals where applicable.
Marketing authorization supported by bioequivalence studies and quality dossiers.

Procurement impact

Supplier availability increases after approvals for each dosage form and strength.
Shortages typically concentrate among sterile fill-finish constrained sites.

What is the Orange Book status of granisetron products and how does it affect supplier entry?

Orange Book status directly affects whether generic manufacturers can file ANDAs with Paragraph IV certifications and when they can launch.

Operational procurement implications

Patented protection and exclusivity can delay launch of certain strengths or dosage forms.
Settlement agreements can define delayed launch windows and volume allocations.

How many patents protect granisetron formulations and methods of use, and where do they matter for supply?

For granisetron, patent coverage typically concentrates on:

compositions (salt forms and specific formulations),
manufacturing or process improvements,
and sometimes method-of-use claims related to CINV/PONV treatment.

What matters to supply continuity

If formulation/process patents cover the exact commercial presentation, new entrants may be blocked or require design-around.
If method-of-use claims are broader, label scope may be affected for certain competitors.

What formulation patents protect granisetron injections versus tablets?

Sterile injection formulations often involve:

excipient systems,
pH and buffering,
stabilization strategy for drug substance,
container closure compatibility.

Tablets often involve:

excipient blends and granulation,
coating and dissolution controls,
manufacturing process steps that drive consistent release.

Procurement risk is higher for injection if the supply chain depends on a single fill-finish site that also supplies other sterile products.

Which generic entry risks exist for granisetron (Paragraph IV, litigation, or supply settlements)?

Granisetron supplier dynamics can be influenced by:

Patent infringement contentions (Paragraph IV for ANDAs)
Section viii carve-outs and settlement-driven launch dates
Product discontinuations that shift demand to remaining suppliers

What tends to create procurement risk

Market is small enough that fewer plants serve multiple strengths.
If a sterile site exits, requalification times can be long.

How do granisetron suppliers compare with alternative antiemetics for CINV and PONV (competitive landscape)?

Granisetron competes with other 5-HT3 receptor antagonists and broader antiemetic regimens:

5-HT3 antagonists (drug class alternatives)
NK1 antagonists
corticosteroids
dopamine antagonists

Supplier strategies depend on formulary positioning and tender pricing rather than only patent status.

Procurement consequences

When alternative agents gain formulary share, granisetron demand can soften.
When supply constraints hit competing agents, granisetron can see demand spikes that tighten allocation.

Where are granisetron suppliers geographically concentrated (US, EU, India, China)?

Granisetron API and finished-dose manufacturing are often distributed globally:

API sourcing frequently includes Asia-based producers supplying global finished-dose makers.
Finished-dose manufacturing is typically concentrated among FDA/EU-inspected sterile and solid-dose plants.

Procurement impact by region

US availability is sensitive to FDA inspection outcomes and release testing timelines.
EU availability is sensitive to batch certification and national tender schedules.

What manufacturing and IP barriers can block new granisetron suppliers?

Barriers affecting supplier entry include:

sterile manufacturing capacity and regulatory inspection history
control of critical impurities and residual solvents in API
ability to demonstrate bioequivalence and formulation comparability
reliance on key excipients or packaging systems with limited qualified vendors
patent coverage forcing design-around for a specific labeled product

Key supplier selection checklist for granisetron procurement

Dosage form support: injection/infusion vs tablet
Regulatory status: FDA/EMA approval coverage for the exact strength and presentation
Sterile QA capacity (for injection): batch release capacity, sterility assurance, and container closure qualification
API qualification: DMF status or equivalent API traceability for the downstream site
Continuity: multi-site supply plans and validated change-control history
Quality systems: recent inspection outcomes and deviation rates
Packaging/labeling fit: UDI readiness for US and compliant labeling for target markets

Key Takeaways

Granisetron supply is driven by three tiers: API producers, finished-dose solid manufacturers (tablets), and finished-dose sterile manufacturers (injection/infusion).
Procurement risk concentrates in sterile fill-finish capacity and in the regulatory/quality qualification of specific dosage forms and strengths.
Orange Book patent and exclusivity status determines which entrants can launch and when, affecting the competitive supplier set for injection and tablets.
Supplier comparison is less about “who can make granisetron” and more about regulatory fit, sterile/solid manufacturing capacity, and qualification readiness for the exact product configuration.

FAQs

Which granisetron strength and dosage form combinations have the tightest supply constraints in the US market?
What excipients and container closure systems most often limit qualified granisetron injection suppliers?
How do API impurity specifications for granisetron hydrochloride affect downstream sterile approval timelines?
What does a Paragraph IV ANDA challenge typically change for granisetron launch dates and supplier availability?
How does switching from granisetron injection to tablet dosing affect hospital procurement and inventory turnover?

References

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
FDA. Drug Approval Reports. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approval-and-database-information
EMA. Human medicines: assessment and approvals. European Medicines Agency. https://www.ema.europa.eu/en/human-medicines

Suppliers and packagers for generic pharmaceutical drug: granisetron

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