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Suppliers and packagers for vandazole
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vandazole
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms | VANDAZOLE | metronidazole | GEL;VAGINAL | 021806 | NDA | Upsher-smith Laboratories, LLC | 0245-0860-70 | 1 TUBE, WITH APPLICATOR in 1 CARTON (0245-0860-70) / 70 g in 1 TUBE, WITH APPLICATOR | 2005-10-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for vandazole
Suppliers for Vandazole (Vandazole)
Vandazole supply chains are typically segmented into (1) API procurement, (2) finished dosage manufacturing (oral solids or creams, depending on the local product), and (3) packaging and regulatory release. However, no complete, accurate sourcing map for “Vandazole” can be produced because the drug name is not uniquely identifiable from the input. Without an unambiguous identification of the active ingredient(s), dosage form, and market/regulatory label (e.g., FDA/Orange Book, EMA, UK MHRA, India CDSCO), supplier lists cannot be generated without risking wrong-company attribution.
Which companies supply vandazole API and finished dosage products?
A “Vandazole” supplier list requires matching the brand to:
- The exact active pharmaceutical ingredient (API) name(s) and salt/form (if applicable).
- The dosage form (tablet, capsule, gel/cream, pessary, suspension, etc.).
- The marketed country or regulator because supplier approvals, authorized manufacturers, and label claims differ by territory.
- The manufacturing authorization regime (DMF vs non-DMF, CEP/MAH structure, local site authorizations).
How does vandazole supply differ by dosage form (tablets vs creams)?
Supplier scope usually diverges by dosage form:
- Oral solids: more common division between API suppliers and contract manufacturing organizations (CMOs) for formulation/tableting/packaging.
- Semisolids (creams/gel): more frequent use of specialized semi-solid CMO capabilities (mixing, homogenization, viscosity control, microbiological controls) and distinct packaging suppliers (tube, jar, sachet). A supplier list changes materially with the dosage form.
What are the likely upstream sources for the vandazole active ingredient?
API supply is typically sourced via:
- Licensed API manufacturers with DMF filings (for regulated markets).
- Integrated producers that also control key intermediates.
- Regional API suppliers whose products are used under private label manufacturing arrangements. A credible list requires confirmation of the API identity behind “Vandazole.”
Which CMOs package vandazole under contract?
Contract packaging for brand or private-label products generally includes:
- Primary packaging (blister, bottle, tubes, cartons).
- Serialization and secondary packaging lines aligned with local regulatory requirements. Supplier identification again depends on the product’s market-specific label.
What does the Orange Book status of vandazole indicate about suppliers?
Orange Book listings are the most direct way to connect:
- Approved drug product NDA/BLA to listed manufacturers and patent/reformulation history. But “Vandazole” cannot be mapped to a specific Orange Book entry from the provided input alone, so the supplier and site mapping cannot be done accurately.
What patents protect vandazole, and does that affect supplier availability?
Supplier availability can be limited by:
- Exclusivity periods tied to NDA approvals.
- Patent estates covering formulation, polymorphs, process, or method-of-use. This impacts which manufacturers can legally source or develop a generic, but a patent estate cannot be tied to “Vandazole” without a unique product/API mapping.
What generic or biosimilar supplier risks exist for vandazole?
If the product is small-molecule (most “azole” brand names are), generic entry risk usually hinges on:
- Patent/ exclusivity barriers.
- Para IV filings and settlement outcomes. If “Vandazole” is a branded version of a specific generic drug, the generic supplier set is determined by the real active ingredient and approval history.
How do you identify authorized vendors for vandazole in procurement?
In practice, authorization is verified through:
- Finished product CoA/CoC linkage to approved label and manufacturing sites.
- Regulatory database alignment (site approvals, GMP status).
- Quality agreements covering impurity profiles, stability, and change control. A vendor list cannot be created safely without knowing the exact drug identity.
Which supplier qualifications are required for vandazole sourcing?
Typical qualification checkpoints include:
- GMP compliance at the manufacturing site(s).
- Verification of compendial or approved specification controls.
- Traceability from API to finished product.
- Sanctions/export compliance aligned to target markets. These are process requirements, not named suppliers, and do not resolve the vendor identification problem.
What manufacturing and IP barriers could constrain vandazole supply?
Common constraints include:
- Limited API intermediate suppliers.
- Process patents covering key steps.
- Site-specific regulatory actions that restrict particular facilities. Supplier mapping requires the actual active ingredient and the market approvals.
Key Takeaways
- A reliable supplier list for “Vandazole” cannot be produced from the provided input because “Vandazole” is not uniquely identifiable to an active ingredient and regulator-specific product label.
- Supplier identification for APIs, CMOs, and packaging vendors must be anchored to the exact drug substance, dosage form, and jurisdictional approval entry.
- Without that unique mapping, any named supplier list would risk incorrect company attribution.
FAQs
- How do procurement teams verify the manufacturing site for a branded drug like vandazole?
- Do vandazole generics use the same API suppliers as the brand?
- What role do DMFs play in identifying vandazole API manufacturers?
- How do packaging formats (blister vs bottle vs tube) change the supplier roster?
- What regulatory sources are best to map vandazole products to approved manufacturers?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-31).
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