Suppliers and packagers for generic pharmaceutical drug: flunisolide

flunisolide

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	FLUNISOLIDE	flunisolide	SPRAY, METERED;NASAL	074805	ANDA	Bausch & Lomb Incorporated	24208-344-25	1 BOTTLE, PUMP in 1 CARTON (24208-344-25) / 25 mL in 1 BOTTLE, PUMP	2002-02-20
Bausch	FLUNISOLIDE	flunisolide	SPRAY, METERED;NASAL	074805	ANDA	Oceanside Pharmaceuticals	68682-344-25	1 BOTTLE, PUMP in 1 CARTON (68682-344-25) / 25 mL in 1 BOTTLE, PUMP	2025-06-01
Riconpharma Llc	FLUNISOLIDE	flunisolide	SPRAY, METERED;NASAL	207802	ANDA	Ingenus Pharmaceuticals, LLC	50742-317-25	1 BOTTLE, PUMP in 1 CARTON (50742-317-25) / 25 mL in 1 BOTTLE, PUMP	2022-06-23

Flunisolide Suppliers: Who Manufactures Active Ingredient (API) and Finished Dosage Forms, and What to Source for US Distribution

Last updated: May 28, 2026

Flunisolide is a corticosteroid used mainly as an intranasal spray (including the historical brand product). Supplier selection turns on whether you need (1) flunisolide API for formulation, (2) contract manufacturing for intranasal spray dosage form, or (3) finished units for channel distribution in the US. Patent and regulatory status drive which manufacturers can supply finished product, while supply-chain and cGMP capabilities determine API and contract formulation access.

Who supplies flunisolide API for pharmaceutical manufacturing?

Answer: Flunisolide API supply is concentrated among global API manufacturers that can support controlled substance-like quality expectations for steroids and nasal drug substances, but the specific “who” depends on whether you source “flunisolide” substance directly or through custom synthesis under tolling.

What to look for in flunisolide API suppliers

Key procurement filters for API:

• Steroid class compliance: verified controls for related substances and polymorph/impurity profile suitable for intranasal corticosteroids.
• Analytical package: impurity method validation, stability-indicating methods, and CoA format compatible with pharma QMS.
• Supply continuity: multi-batch lot history and ability to cover seasonal nasal demand spikes.
• Regulatory alignment: cGMP manufacturing and batch traceability.

API supply chain structure you should expect

Most flunisolide API availability in commercial channels falls into one of these sourcing paths:

• Direct API purchase from an API manufacturer.
• Toll manufacture for API with a spec tied to a finished-dose customer.
• Purchased intermediate route (less common) when the API maker partners with an intermediate supplier.

Which companies supply flunisolide intranasal spray finished dosage forms in the US?

Answer: Finished intranasal flunisolide supply is typically provided by branded and generic manufacturers that hold FDA approval for specific NDCs. The “supplier” in this context is the FDA-approved applicant listed for each NDC, plus the firms doing contract packaging and distribution.

How to identify finished-product suppliers correctly

For intranasal sprays, the reliable supplier mapping is:

• FDA labeler/applicant tied to each NDC.
• Manufacturer of record for drug product (DP) and packaging.
• Any CMOs involved in filling and secondary packaging.

Common finished-dose sourcing model

• Generic or authorized holders import or manufacture drug product in bulk, then contract fill/pack into patient-ready units.
• Wholesalers then distribute under US channel.

What dosage forms and strengths use flunisolide suppliers most?

Answer: Flunisolide is supplied primarily for intranasal use. Supplier requirements vary by whether you source:

• Unpackaged bulk drug product (bulk DP for co-packers)
• Filled and packaged nasal spray units (primary container with metered dose actuator)
• Kit-based products if the labeling requires specific device configuration

Key device/packaging details that change supplier capability

Intranasal sprays depend on:

• Metering accuracy of the actuator
• Container compatibility with formulation
• Spray particle uniformity and plume characteristics
• Delivered dose consistency across lots

How do flunisolide contract manufacturing and CMO suppliers differ from API suppliers?

Answer: Contract manufacturing suppliers for intranasal flunisolide focus on drug product formulation, sterile and aseptic risk controls where applicable (depending on process), and dose-metering performance. API suppliers focus on chemical synthesis and impurity controls.

Drug product manufacturing workstreams you will see

• Formulation development and compounding into spray suspension
• Bulk filling and container-closure integrity controls
• Primary packaging and labeling compliance
• Stability programs aligned to shelf life claims

What are the regulatory and quality checkpoints that flunisolide suppliers must meet?

Answer: In the US, flunisolide finished products must align with FDA’s cGMP expectations and demonstrate quality through chemistry, manufacturing, and controls (CMC) plus stability data. API suppliers must meet identity, purity, impurity limits, and batch traceability requirements used by the finished-dose applicant.

Quality systems that matter for nasal steroids

• Impurity profiling for corticosteroid-related substances
• Preservative and excipient control suitable for intranasal deposition
• Microbiological controls tied to product type and process
• Cross-functional change control between API and DP specs

What manufacturing/IP constraints affect which suppliers can sell flunisolide?

Answer: Availability depends on whether a supplier is supplying an approved generic or branded product for the relevant NDC and whether any patent or exclusivity barriers apply for that specific product configuration.

Why product-level IP matters for supplier access

• A supplier may be able to make flunisolide API but still be blocked from selling a specific intranasal spray NDC if it is tied to protected formulation, device, method-of-use, or listed patents.
• Even after patent expiry, practical supply depends on FDA approval status and manufacturing readiness.

How do you compare flunisolide suppliers by commercial readiness?

Answer: Evaluate suppliers on operational readiness for your channel needs:

• Ability to supply consistent lots
• Lead times and MOQ for API versus finished units
• Documentation readiness for regulatory audits
• Track record for nasal dosage form fill-to-fill consistency

Supplier comparison criteria (actionable procurement checklist)

• Regulatory readiness: batch records and CoA completeness
• Stability history: data supporting shelf life for the exact packaging configuration
• Supply continuity: multi-quarter production capacity
• Change control discipline: documented process for spec changes
• Audit footprint: history of GMP inspections and corrective actions closure

What generic entry risks exist for flunisolide if you plan to add new supply?

Answer: New supply entrants face approval and CMC execution risks, not just formulation science. Even with an available API, applicants must clear:

• FDA approval for the exact NDC presentation
• CMC comparability or reference product alignment
• Device and delivery system performance expectations

Where supply disruptions typically occur

• Actuator/device performance changes
• Container-closure compatibility issues
• Stability failures linked to excipient or container interaction
• QC method transfer failures between DP sites

Key Takeaways

• Flunisolide supply splits into API sourcing and intranasal spray finished-dose supply; each has different supplier qualification requirements.
• Finished-dose suppliers are identified reliably by FDA-approved status per NDC, plus manufacturers of record for drug product and packaging.
• Supplier selection for intranasal steroids depends on dose metering performance, packaging integrity, impurity controls, and CMC documentation readiness.
• New or switching suppliers for flunisolide should be evaluated on regulatory approval status, stability alignment to the exact packaging, and supply continuity.

FAQs

1) What should I request from flunisolide API suppliers in due diligence?
CoA with impurity profile, identity data, traceability, GMP statement, batch records excerpt, stability protocol, and method validation package aligned to the spec used by your finished-dose plan.

2) Can I source flunisolide API and formulate intranasal spray with any CMO?
Not if the CMO lacks nasal spray device filling competency, container-closure compatibility capability, or stability and QC methods aligned to corticosteroid suspension products.

3) How do I determine the correct supplier for flunisolide finished goods tied to a specific NDC?
Match the NDC to the FDA labeler/applicant and identify the drug product and packaging manufacturer of record from FDA product listing/label.

4) What drives lead-time differences between API and finished flunisolide sprays?
API procurement hinges on synthesis schedule and release testing, while finished sprays hinge on bulk manufacturing, fill lines, actuator/device procurement, packaging, and stability pull strategy.

5) What quality failures are most common for intranasal steroid suppliers?
Dose delivery inconsistency, instability due to container-excipient interaction, and microbiological or particulate specification failures tied to suspension handling and process controls.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA. (Database). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
3. FDA. Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals. U.S. Food and Drug Administration. https://www.fda.gov/drugs/pharmaceutical-quality-machinery/cgmp-current-good-manufacturing-practice-finished-pharmaceuticals