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Suppliers and packagers for ZAVZPRET
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ZAVZPRET
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | ZAVZPRET | zavegepant hydrochloride | SPRAY, METERED;NASAL | 216386 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-3500-02 | 6 BLISTER PACK in 1 CARTON (0069-3500-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0069-3500-01) / .1 mL in 1 VIAL, SINGLE-DOSE | 2023-06-01 |
| Pfizer | ZAVZPRET | zavegepant hydrochloride | SPRAY, METERED;NASAL | 216386 | NDA | U.S. Pharmaceuticals | 63539-135-02 | 1 BLISTER PACK in 1 CARTON (63539-135-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (63539-135-01) / .1 mL in 1 VIAL, SINGLE-DOSE | 2023-06-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for ZAVZPRET
Zavzpret (zavzpret) Suppliers: Who Manufactures, Supplies, and Sponsors the Drug and Its Commercial Supply Chain
Zavzpret is supplied by its brand sponsor for the US market, with manufacturing and packaging tied to the drug’s application holders and contract manufacturing partners listed for the product. Based on available public records, the drug’s supply chain is controlled by the marketing authorization holder and the associated manufacturing sites shown in FDA-related listings and label/application data.
Who are the key suppliers and manufacturers for ZAVZPRET (zavzpret)
Answer: The key “suppliers” for Zavzpret are (1) the marketing authorization holder/sponsor that lists the product and (2) the contract manufacturing organizations (CMOs) and packaging sites assigned to manufacturing and finished product release for the marketed dosage form, as reflected in FDA product labeling and application records.
Commercial sponsor vs. manufacturing sites
- Sponsor / holder responsible for US marketing: The entity that holds the US marketing authorization and appears as the application/labeling sponsor for Zavzpret.
- Manufacturing and packaging suppliers: The named manufacturing sites responsible for drug substance (if applicable) and drug product (finished dosage form), and packaging/release where specified.
What “supplier” means in practice
For supply-chain diligence, “suppliers” usually maps to:
- Finished-dose manufacturing sites (drug product release)
- Packaging and labeling sites (secondary packaging)
- Sterility/aseptic or solid-dose manufacturing lines (as applicable)
- Drug substance manufacturing plants (if the sponsor discloses it in label/application materials)
What companies manufacture zavzpret drug product and package it
Answer: The manufacturer and packaging-site entities are identified in the product’s US label and/or FDA listing for the approved finished dosage form, and they are the practical upstream suppliers used for inventory generation.
Dosage form and supply constraints
Zavzpret’s dosage form and use profile determine which manufacturing controls apply (for example, solid-dose process controls vs. sterile process controls). Those controls map to specific CMO capabilities and release testing workflows.
What drug substance suppliers support Zavzpret
Answer: Drug substance suppliers are the entities named for drug substance manufacture in FDA-related application disclosures and label detail, where present.
Why drug substance suppliers matter for continuity
If the drug substance supply is single-sourced, any disruption at the API or intermediate manufacturing plant propagates to finished-dose availability. If multiple DS suppliers are disclosed, that supports contingency planning.
What is the FDA regulatory status of Zavzpret suppliers (application holder, label sponsor, and listing)
Answer: The regulatory status of Zavzpret ties supplier identification to the FDA application holder and the product label’s manufacturing information. These are the entities responsible for cGMP compliance and inventory release for the US market.
Orange Book and FDA databases linkage
Supplier-identification diligence typically crosswalks:
- FDA product listing records for manufacturer/sponsor
- The application-holder identity that controls regulatory submissions
- The label manufacturing/distribution information that can list site-level manufacturers
Which CMOs are involved in ZAVZPRET manufacturing and packaging
Answer: The CMOs involved in Zavzpret manufacturing and packaging are those assigned to the drug product release and packaging steps in the FDA label and application supply chain disclosures.
Site-level diligence points
- Finished-dose release testing site
- Packaging and labeling site
- Any noted alternate manufacturing sites (if the label/application lists more than one location)
How strong is the patent estate for Zavzpret suppliers and what does it mean for manufacturing
Answer: For supplier strategy, patent estate strength affects the availability of contract manufacturing and the feasibility of “early” process development or secondary sourcing. It does not change which entities manufacture under license.
Manufacturing barriers created by IP
- Process patents can restrict method-of-manufacture transfers
- Formulation or polymorph patents can constrain control strategies and compendial equivalence
- Method-of-use patents can affect certain clinical labeling positions and lifecycle extensions
What generic or biosimilar entry risks exist for Zavzpret that could change suppliers
Answer: Generic entry risk would change supplier dynamics only if additional ANDA manufacturers or authorized generics appear and if the product’s regulatory pathway allows it. For products with exclusivity barriers or tight IP, new suppliers are unlikely to appear quickly.
Paragraph IV, exclusivity, and timing
Supplier substitution is typically downstream of:
- Patent expiry or carve-outs
- Exclusivity windows ending
- ANDA approvals and labeling changes
- Litigation outcomes affecting launch authorization
How does Zavzpret compare with other competitor drugs on supply sourcing
Answer: Supply sourcing for similarly positioned specialty oncology/rare disease brands is usually controlled by the sponsor and a limited set of CMO release sites, with secondary sourcing only added after operational scale needs or regulatory/pathway incentives arise.
Benchmarking frameworks used by buyers
- Number of release sites disclosed
- Existence of multiple packaging sites
- Contract duration signals (where discoverable)
- Supply disruption track record (where publicly reported)
Timeline: when supplier changes typically occur for Zavzpret
Answer: In specialty drug supply chains, supplier changes occur primarily after:
- Manufacturing tech transfers
- Process validation lifecycle updates
- Line expansions or site relocations
- Exclusivity/patent lifecycle transitions that enable alternative supply arrangements
What to monitor
- Label updates indicating manufacturing site changes
- Supplement filings that add or remove manufacturing sites
- FDA listing updates reflecting site additions
Key Takeaways
- “Suppliers” for Zavzpret are the FDA label/application sponsor plus the named manufacturing and packaging sites controlling drug product release and packaging for the US market.
- Supplier identification must be anchored to FDA-related listings and the Zavzpret label’s manufacturing/packaging information.
- Patent and exclusivity timelines influence whether new manufacturers and secondary suppliers can enter without IP friction.
FAQs
1) Where on Zavzpret packaging or labeling are manufacturing and packaging sites disclosed?
In the US product labeling, manufacturing and packaging responsibilities are shown in the “Manufactured for” and related sections, which map to the actual release and packaging suppliers.
2) Do ZAVZPRET suppliers differ for US vs. ex-US markets?
Yes. Market-specific labeling and application records can show different CMOs or release sites by jurisdiction.
3) How can I verify the finished-dose manufacturer for Zavzpret?
Crosswalk the label’s manufacturer/packager statements to FDA product listing records for the finished dosage form.
4) Can a second supplier appear via tech transfer without label change?
Often tech transfer additions require label updates or FDA listing updates to reflect manufacturing responsibility for commercial supply.
5) Does supplier identity affect pricing or contracting for Zavzpret?
Supplier identity influences supply reliability and manufacturing lead times, which can affect contracting terms, but pricing is also driven by market exclusivity, payer negotiations, and brand competition.
References (APA)
- FDA. (n.d.). Drug product information and labeling resources for US prescription drugs. U.S. Food and Drug Administration. https://www.fda.gov/
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
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