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Suppliers and packagers for generic pharmaceutical drug: AMOXICILLIN; VONOPRAZAN FUMARATE
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AMOXICILLIN; 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 DUAL PAK | amoxicillin; vonoprazan fumarate | CAPSULE, TABLET;ORAL | 215153 | NDA | Phathom Pharmaceuticals Inc. | 81520-250-14 | 14 BLISTER PACK in 1 CARTON (81520-250-14) / 1 KIT in 1 BLISTER PACK (81520-250-01) | 2023-11-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: AMOXICILLIN; VONOPRAZAN FUMARATE
Who Supplies Amoxicillin and Vonoprazan Fumarate for Pharmaceuticals?
Amoxicillin and vonoprazan fumarate are supplied through different upstream industrial routes:
- Amoxicillin is a widely produced beta-lactam API with broad global sourcing for API and intermediates.
- Vonoprazan fumarate is sourced through a narrower set of specialized API producers tied to PA (pyridine) and benzimidazole-derivative chemistry and salt formation.
Because supplier lists depend on the exact product form (API vs intermediate), grade (USP/EP/ICH), and intended market registrations, this analysis is limited to supplier categories and supply-chain roles that are consistently relevant for procurement and regulatory submissions.
What supplier types cover Amoxicillin?
| Supply-chain role | What they provide | Typical procurement target |
|---|---|---|
| API manufacturers | Amoxicillin API (often as trihydrate or anhydrous depending on grade) | DMF/ASMF-backed API |
| Intermediate producers | Key penicillin-sidechain and fermentation related intermediates | For API outsourcing or internal blending |
| Contract manufacturers | Finished dose manufacturing using sourced API | NDA/ANDA-ready batches |
| Specialty distributors | Fast supply of commercial API with cold-chain controls if required | Short lead-time procurement |
| Tollers (process) | Beta-lactam penicillin core modifications and purification services | Scale-up for new dossiers |
Procurement reality for amoxicillin: global tendering is dominated by API producers in regions with mature penicillin fermentation and side-chain acylation capacity (India, China, parts of Europe). Finished-dose manufacturers also dual-source amoxicillin across multiple API plants to manage batch-by-batch impurity drift.
What supplier types cover Vonoprazan fumarate?
| Supply-chain role | What they provide | Procurement target |
|---|---|---|
| API manufacturers | Vonoprazan fumarate API | ASMF/DMF-backed API with salt form confirmation |
| Salt-form specialists | Fumaric acid salt formation, conversion, and crystallization | Particle size and polymorph control |
| Contract manufacturers | Tablets/capsules using sourced API | GMP manufacturing with validation pack |
| Specialized intermediates suppliers | Custom intermediates for the vonoprazan scaffold | Route-compatible intermediates for consolidation |
Procurement reality for vonoprazan fumarate: the supplier set is smaller due to chemistry complexity and the need for consistent impurity profiles plus stable salt form control. Buyers typically qualify at least two API sources and lock material specs tightly.
Which suppliers provide these drugs most commonly in industry?
Without a specified geography, dosage form, and whether you want API or finished product, the only defensible “supplier list” at this resolution is by proven procurement segments and where qualification usually lands. In practice:
- Amoxicillin is sourced from large-scale API plants that supply both generic and branded markets.
- Vonoprazan fumarate is sourced from a smaller number of qualified API producers and tolling networks with proven salt-formation control.
How do buyers qualify suppliers for Amoxicillin?
Key qualification requirements for amoxicillin procurement usually include:
- DMF/ASMF support (route, impurity synthesis, and manufacturing controls)
- Impurity profile alignment with pharmacopeia/spec and target region dossier needs
- Batch-to-batch consistency for beta-lactam impurity markers
- Stability data for the actual storage conditions intended by the finished-dose maker
- Quality systems compatible with GMP audits (often including specific CMC controls for beta-lactam handling)
How do buyers qualify suppliers for Vonoprazan fumarate?
Qualification centers on:
- Salt form verification (fumarate confirmation) and control of conversion during storage
- Crystallization and particle size (impacts dissolution and downstream formulation behavior)
- Impurity set control aligned to the synthetic route described in regulatory files
- Solid-state stability (including any polymorph or hydrate drift risk depending on product spec)
- Analytical method transfer readiness (HPLC/LC-MS method robustness for route-related impurities)
Actionable procurement framework (what to do with supplier sourcing)
Amoxicillin procurement checklist
- Source API with complete regulatory file coverage (DMF/ASMF) for your target jurisdictions.
- Require batch release specs that match your finished-dose formulation and impurity acceptance criteria.
- Lock lead-time and minimum order quantities across at least two suppliers to manage fermentation variability.
- Demand stability and retest periods that match your supply chain shelf-life needs.
Vonoprazan fumarate procurement checklist
- Require salt form and solid-state evidence (fumarate, and any relevant polymorph attributes per the supplier’s qualified spec).
- Enforce impurity limits consistent with dossier-defined targets.
- Qualification should include formulation-relevant performance (dissolution) if you are switching suppliers.
- Dual-source where possible, but keep process and spec comparability tight to avoid rework.
Key Takeaways
- Amoxicillin supply is broad and usually competitively sourced across multiple global API and intermediate producers.
- Vonoprazan fumarate supply is narrower, with qualification hinging on fumarate salt form and solid-state control.
- Supplier strategy for both should be built around regulatory file availability (DMF/ASMF), impurity control, and batch consistency, with vonoprazan requiring extra focus on salt form and crystallization behavior.
FAQs
1) Are amoxicillin and vonoprazan fumarate usually sourced as APIs or intermediates?
Most procurement is for API. Some buyers also source specialized intermediates for custom manufacture, but dossier and release constraints make API the dominant path for commercial operations.
2) What is the main sourcing risk for amoxicillin?
Batch variability tied to manufacturing route and beta-lactam impurity control, which can affect release compliance and formulation stability.
3) What is the main sourcing risk for vonoprazan fumarate?
Salt form and solid-state drift, which can change dissolution behavior and cause spec excursions unless tightly controlled.
4) How many suppliers should a buyer qualify for these drugs?
Procurement standard is to qualify at least two for continuity. For vonoprazan fumarate, buyers often keep the supplier set smaller due to qualification cost and solid-state comparability needs.
5) Do supplier lists differ by market (US, EU, Japan)?
Yes. Qualified suppliers depend on whether they hold supporting regulatory documentation (DMF/ASMF) and whether their manufacturing sites are accepted for the intended jurisdiction.
References
[1] U.S. Food and Drug Administration. “Drug Master Files (DMF).” FDA.gov.
[2] European Medicines Agency. “Active substance master files (ASMF).” EMA.europa.eu.
[3] World Health Organization. “Guidelines on submission of documentation for pharmaceutical products.” WHO.
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