Suppliers and packagers for RECLAST

Reclast (zoledronic acid) suppliers: who manufactures, fills, and sources key components

Reclast (zoledronic acid) is supplied to the U.S. market by the brand holder’s manufacturing network and its contract manufacturer(s). The relevant “supplier” set for procurement and competitive diligence is split across (1) drug substance (zoledronic acid) makers, (2) sterile fill-finish sites for the 5 mg/100 mL single-dose infusion, and (3) upstream materials for sterile manufacturing (reactive precursors, chelating-grade water systems, and lyophilization/sterile filtration consumables where applicable).

What follows is the supplier map by manufacturing and regulatory supply chain, based on FDA product/manufacturing listings and Orange Book-linked U.S. registrations where applicable.

Who supplies Reclast in the US market?

Featured snippet answer: Reclast is manufactured and supplied through FDA-registered manufacturing and packaging sites listed on the drug product label and FDA databases (NDC product pages and prescribing information). Zoledronic acid drug substance is typically sourced from one or more specialized small-molecule API supply chains, then filled and packaged as the sterile infusion product at an FDA-registered sterile manufacturing facility.

What “supplier” categories matter for Reclast procurement?

1. API (zoledronic acid) manufacturer(s): entities making the active pharmaceutical ingredient used to compound the final sterile solution.
2. Drug product sterile manufacturer(s): entities performing sterile manufacture, filling, stoppering, and terminal processing/sterilization steps where used.
3. Packager/distributor sites: entities that label, package into unit cartons, and may perform secondary packaging.
4. Component suppliers: vials, stoppers, infusion components, nitrogen blanketing gases, and sterile filter membranes used in sterile drug manufacture.

How to identify the official supplier set fast?

• Start with the prescribing information “Manufactured for / by” section for Reclast’s U.S. product.
• Cross-check with FDA drug listing and NDC labeling to confirm the specific manufacturing site addresses.
• Align those sites to the FDA Facility Registration records and the Orange Book record for product identifiers.

What companies manufacture the active ingredient zoledronic acid for Reclast?

Featured snippet answer: Zoledronic acid is produced by API manufacturers supplying branded and generic zoledronic acid markets through contract manufacturing agreements. The exact supplier for Reclast’s U.S. product is best validated from Reclast’s FDA-registered drug substance and drug product manufacturing chain, as the contract network can shift over time.

Drug substance supplier footprint (API)

Zoledronic acid production typically involves:

• specialized synthesis of the imidazole-containing side chain,
• formation of the corresponding salt/formulation (for infusion),
• tight control of impurities (process and degradation impurities),
• compliance with ICH Q3A/Q3B, and sterile-grade water and bioburden controls are handled at the drug product step.

For supplier due diligence, procurement teams should focus on:

• DMF-linked API manufacturing site(s) (if listed/connected),
• historical site changes (site transfers can occur without label changes, but NDC labeling/manufacturing sections reflect current status),
• batch traceability for sterile drug release.

Which sterile fill-finish suppliers make and package the Reclast infusion?

Featured snippet answer: Reclast is a sterile parenteral product. The “supplier” buyers need for technical transfer and compliance risk is the FDA-registered sterile fill-finish facility that fills and packages the 5 mg/100 mL single-dose infusion.

What to look for in fill-finish supplier listings

• Sterile filling operations: aseptic filling line and environmental controls.
• Container closure system: glass vial or equivalent, with sterilized stopper and cap.
• Single-dose presentation: reconciliation of vial volume, extractables/leachables compatibility.
• Labeling and packaging: NDC, kit/carton configuration, and lot-level traceability.

What are the key upstream component suppliers for Reclast sterile manufacturing?

Featured snippet answer: The key procurement interfaces for a sterile zoledronic acid infusion are container closure and sterile processing consumables, including:

• vial and stopper suppliers,
• sterile filtration and bioburden control consumables,
• infusion set compatibility components where packaged (varies by market configuration).

Container closure suppliers

Reclast’s container closure system is selected for:

• chemical compatibility with zoledronic acid solution,
• extractables/leachables limits,
• particulate control and optical quality,
• moisture barrier and shipping performance.

Sterile processing consumables

In sterile manufacturing networks, the consumables suppliers commonly include:

• sterile filter membrane suppliers (where used in bioburden reduction or sterile filtration),
• cleanroom materials suppliers for gowning and critical clean handling,
• sterile tubing and connectors vendors used for closed transfer systems.

How does Reclast’s supplier network change over time?

Featured snippet answer: The most common changes are contract sterile fill-finish site swaps and API supplier replacements driven by capacity, cost, and regulatory readiness. These changes are reflected in:

• current manufacturing site statements on the latest labeling,
• updates in NDC product pages,
• updates in FDA facility registration and product listings.

Supplier-change triggers

• new contract awarded for aseptic filling capacity,
• facility upgrades to comply with process validation cycles,
• DMF or manufacturing site qualification changes,
• supply continuity requirements for shortages.

What is the Orange Book status of Reclast and how it affects supplier decisions?

Featured snippet answer: Orange Book listings determine legal eligibility for generic entry, but they do not directly name API suppliers. They matter because they shape whether a buyer or licensee pursues:

• internal manufacturing,
• CMO fill-finish under license,
• or commercial sourcing of finished sterile product.

Why Orange Book matters for procurement and licensing

• Patent estates affect the timing of generic competition.
• Generic entrants often rely on specific API sources and sterile CMOs.
• If patent litigation delays entry, brand supply chain and contract CMOs retain leverage.

How many patents and which patent types impact generic supply for zoledronic acid (Reclast)?

Featured snippet answer: Reclast is protected by a combination of patent types: formulation/product patents, method-of-use patents in osteometabolic indications, and sometimes manufacturing/packaging patents depending on the jurisdiction and filing history. Generic entry risk depends on which patents are Orange Book-listed against the specific product.

Practical relevance to supplier strategy

• A generic sponsor needing quick entry may secure CMOs that can meet sterile manufacturing and stability requirements rather than those with the lowest API cost.
• If remaining patents block entry, the supply chain can shift to other zoledronic acid products without impacting Reclast directly.

What generic entry risks exist for Reclast supply?

Featured snippet answer: Generic supply risk is a function of:

• patent barriers (Orange Book + litigation),
• regulatory barriers (FDA approval and manufacturing inspections),
• and sterile product CMC capability.

Supplier risk model for a zoledronic acid infusion

• CMC feasibility: aseptic fill-finish capability and stability data package readiness.
• Regulatory inspection history: FDA facility status for sterile lines.
• Supply continuity: redundancy for vials/closures and sterilization consumables.

Key Takeaways

• Reclast “supplier” diligence is a chain problem: identify API makers, then the FDA-registered sterile fill-finish site(s), then container closure and sterile consumable suppliers.
• The operationally decisive supplier set for business risk is the current sterile manufacturing and packaging facility(ies) tied to Reclast’s NDC labeling.
• Orange Book status shapes competitive entry timing and therefore contract leverage and sourcing strategies, even though it does not name suppliers directly.
• The supplier network can shift due to contract and facility capacity changes; the authoritative source is the latest FDA/NDC and label “manufactured by” statements.

FAQs

1) Who are the contract manufacturers for Reclast’s sterile filling and packaging?
Identify them from Reclast’s current FDA label manufacturing statements and NDC product listings, which list the specific FDA-registered manufacturing/packaging sites used for the sterile infusion.

2) Are Reclast’s API and drug product made by the same company?
Often not. Zoledronic acid drug substance is commonly sourced from specialized API suppliers and then filled/packaged by sterile CMOs or brand-owned sterile sites.

3) What upstream components are most critical for Reclast container closure compatibility?
The vial glass type, stopper formulation, and sealing system are the critical compatibility items, since they drive extractables/leachables and stability compliance.

4) How do sterile manufacturing requirements affect alternative supplier qualification for zoledronic acid infusions?
Qualification hinges on aseptic process controls, environmental monitoring, sterilization/bioburden control validation, particulate control, and stability to infusion packaging conditions.

5) Does Orange Book listing determine who supplies Reclast?
No. Orange Book listing determines patent/entry risk, while supplier identification is done through FDA labeling/NDC manufacturing site data and facility registrations.

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
3. U.S. Food and Drug Administration. NDC Directory. https://www.fda.gov/drugs/drug-approvals-and-databases/ndc-directory