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Suppliers and packagers for generic pharmaceutical drug: vonoprazan fumarate
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vonoprazan fumarate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Phathom | VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151 | NDA | Phathom Pharmaceuticals Inc. | 81520-100-30 | 30 TABLET in 1 BOTTLE, PLASTIC (81520-100-30) | 2023-11-10 |
| Phathom | VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151 | NDA | Phathom Pharmaceuticals Inc. | 81520-200-30 | 30 TABLET in 1 BOTTLE, PLASTIC (81520-200-30) | 2023-11-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for vonoprazan fumarate (Vonoprazan): API and key manufacturer landscape
Vonoprazan fumarate supply is concentrated in a small set of active pharmaceutical ingredient (API) and dosage-form manufacturers that have historically serviced Takeda’s vonoprazan program (Voquezna in the US). The commercial supply chain is dominated by (1) Takeda’s established manufacturing relationships for tablets and packaging and (2) API makers supplying the H. pylori and GERD/erosive esophagitis markets, with sourcing typically controlled through qualification and change-control under cGMP.
Who supplies vonoprazan fumarate API?
Answer: The most reliable view of “who supplies” comes from (a) Takeda’s finished-dose manufacturing footprint for vonoprazan products and (b) the API listed in regulatory filings and marketed product labeling. For vonoprazan, the practical supplier universe is narrower than for many small-molecule drugs because Takeda’s launch and ongoing commercialization require tight qualification.
What to look for in supplier identification
- Finished-dose manufacturers on US prescribing information and FDA product labeling (site-of-manufacture for tablets).
- API and intermediate sites listed in global regulatory dossiers (often mirrored in cGMP inspections and DMFs).
- Contract manufacturing organizations (CMOs) named in manufacturing sections of regulatory submissions and approvals.
Vonoprazan fumarate finished-dose manufacturing vs API supply
- Finished-dose tablet manufacturing suppliers are usually easier to identify from labeling.
- API supplier identification is less direct unless an API holder is explicitly disclosed in:
- FDA labeling/manufacturing sections,
- DMF public access filings (where available),
- or inspection/consent decree records.
Data gap constraint: No authoritative, citable supplier roster (company names mapped to API vs finished dose) is provided in the prompt, and this response cannot generate a complete and accurate supplier list without specific labeled or dossier-backed entities.
Which companies make vonoprazan fumarate tablets (finished product suppliers)?
Answer: The identifiable suppliers are the tablet manufacturers appearing on vonoprazan fumarate product labeling for the marketed strengths.
Why finished-dose suppliers matter for procurement
- Customs and procurement are typically executed at the finished-dose level for launches.
- Procurement risk is driven by:
- compression/coating line capacity,
- stability performance (shelf-life constraints),
- packaging line availability (bottle/blister),
- and regulatory change control.
How supplier qualification usually works
- API and drug product CMOs require:
- conformance to Takeda’s quality systems,
- validated manufacturing process,
- stability protocol and comparability studies,
- and ongoing OOS/OOT deviation reporting alignment.
How does vonoprazan fumarate supply chain differ from generic supply?
Answer: Generic supply chains usually add at least two layers: (1) an API qualification phase for the DMF/ASMF and (2) drug product manufacturing with bioequivalence strategy and formulation control.
Supply-chain pressure points
- API particle size and polymorph control (process sensitivity).
- Tablet dissolution alignment with reference listed drug (RLD) dissolution specs.
- Coating and compression robustness across equipment vendors.
- Stability and packaging compatibility.
Generic entry and supplier churn
When generics enter, the supplier base can broaden, but only after regulatory and quality approvals. During early generic ramp, supply is often conservative to avoid lot failures.
What procurement and licensing risks exist for vonoprazan fumarate?
Answer: The key risks are not only capacity related; they also include quality drift and IP/technology transfer constraints.
Typical constraints that affect supplier selection
- Technology transfer restrictions for:
- API crystallization/polymorph processes,
- key intermediates and impurity profiles,
- and validated dissolution-relevant formulation parameters.
- Contractual limitations linked to exclusive commercial arrangements (where applicable).
- Regulatory filing strategy alignment (DMF/ASMF choice, ANDA pathway compatibility).
What are common vonoprazan fumarate manufacturing and quality specifications that suppliers must meet?
Answer: Suppliers must match reference dissolution profiles, impurity limits, and stability performance consistent with cGMP and the approved dossier.
Quality attributes procurement teams usually screen
- API impurity profile and control strategy (process-related impurities).
- Residual solvents (if applicable to the route).
- Physical form/polymorph control of the fumarate salt.
- Particle size distribution and flow properties.
- Tablet dissolution and disintegration time range.
- Stability under labeled storage conditions and packaging.
Key Takeaways
- Vonoprazan fumarate supply is typically limited to a small, qualified set of API and finished-dose manufacturers supporting Takeda’s commercialization.
- Finished-dose manufacturers are the easiest to identify from product labeling; API suppliers require regulatory-file or DMF-based evidence.
- Supplier qualification is process- and quality-control heavy, with high sensitivity to API form, impurities, and dissolution alignment.
- Procurement risk is driven by cGMP capacity, stability, and change-control rather than just availability.
FAQs
- How do I identify the vonoprazan fumarate API supplier from regulatory documents?
- What cGMP and quality system requirements are most critical for vonoprazan fumarate tablet manufacturers?
- What dissolution and stability specs drive supplier qualification for vonoprazan fumarate tablets?
- Do vonoprazan fumarate generics expand the supplier base, and how fast can supply ramp?
- What manufacturing process controls matter most for vonoprazan fumarate salt form consistency?
References
- FDA. Prescribing information and product labeling for vonoprazan fumarate (Voquezna) (latest available).
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