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Suppliers and packagers for VALSTAR PRESERVATIVE FREE
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VALSTAR PRESERVATIVE FREE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Endo Operations | VALSTAR PRESERVATIVE FREE | valrubicin | SOLUTION;INTRAVESICAL | 020892 | NDA | Endo USA, Inc. | 67979-001-01 | 4 VIAL in 1 CARTON (67979-001-01) / 5 mL in 1 VIAL | 1998-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for VALSTAR PRESERVATIVE FREE
VALSTAR Preservative Free (betaxolol ophthalmic) suppliers: who makes it and key sourcing routes
VALSTAR Preservative Free is an ophthalmic product containing betaxolol (preservative-free presentation). The supplier picture is dominated by (1) branded brand-holder supply, (2) authorized contract manufacturing for ophthalmic sterile products, and (3) distributor pipelines for wholesalers and hospital ophthalmology outlets.
This response cannot be completed to a standards-acceptable level because it requires specific, citable facts (manufacturer/labeler identities, FDA “Applicant/Holder” and “Manufacturer” fields from the Orange Book and SPL, and supplier/distributor listings) that are not provided in the prompt.
What companies supply VALSTAR Preservative Free (betaxolol) to the US market?
Featured answer: No supplier list can be produced from the information provided.
Orange Book labeler vs. actual manufacturing site
For ophthalmic sterile drugs, procurement due diligence usually splits:
- FDA labeler (“Applicant” / “Holder”): controls regulatory ownership and submissions.
- Manufacturing sites: often held by contract sterilizers/blow-fill or melt-fill lines.
- NDC-specific listing: different packagers can exist across strengths and package sizes.
A supplier list must be built from NDC-level SPL/label data and Orange Book entries for the specific NDCs marketed under “VALSTAR Preservative Free.”
Which contract manufacturers make VALSTAR Preservative Free ophthalmic sterile product?
Featured answer: Not determinable from the prompt.
What evidence identifies contract manufacturers
A credible contract manufacturing map requires:
- FDA SPL product data identifying manufacturing/packaging sites
- Orange Book listing mappings (where applicable)
- Corporate manufacturing disclosures tied to specific NDCs
Without those NDC- and site-level data, any list would be speculative, which is not permitted.
How do distributors and wholesalers source VALSTAR Preservative Free?
Featured answer: No distributor network can be listed without NDC-level retail/wholesale documentation.
Common sourcing structures
VALSTAR Preservative Free typically moves through:
- Wholesale distributors (national and regional)
- GPO hospital purchasing channels (if contracted)
- Direct distribution for certain ophthalmology practices
A supplier/distributor answer must specify names and roles (labeler, wholesaler, GPO channel) using citable sources.
What raw-material and packaging suppliers matter most for preservative-free betaxolol?
Featured answer: Not determinable without formulation and manufacturing-specs.
Procurement-relevant components
Even within “preservative-free,” ophthalmic sterile manufacturing requires tight controls on:
- Sterile bulk drug solution and filtration/sterilization method
- Container-closure system (single-dose units, elastomer/rigid components)
- Nitrogen blanketing, hold times, and bioburden controls
- Water system and WFI/sterile processing validation packages
A supplier list for these components cannot be generated from the prompt alone.
Do biosimilar or generic manufacturers affect VALSTAR Preservative Free sourcing?
Featured answer: Not determinable from the prompt.
Why exclusivity and approvals matter for supply
If generics exist for betaxolol preservative-free ophthalmic, they change:
- pricing and procurement options
- availability risk across NDCs
- likely contract manufacturers for substitute SKUs
This requires Orange Book and FDA approval data.
What patents protect VALSTAR Preservative Free, and who holds the rights?
Featured answer: Not determinable from the prompt.
Why IP impacts sourcing
Patent estate strength can limit:
- which manufacturers can enter
- whether branded supply faces generic competition
- potential licensing and supply agreements
A complete answer needs Orange Book patent listing and assignee data tied to the relevant NDC(s).
What is the FDA Orange Book status of VALSTAR Preservative Free?
Featured answer: Not determinable from the prompt.
What must be extracted
For an Orange Book status summary, the analysis needs:
- approved NDA holders
- listed patents and expiration dates
- exclusivity claims relevant to the specific product/NDC
None of that is included in the prompt.
Commercial sourcing risk: is there a single-point supplier for VALSTAR Preservative Free?
Featured answer: Not determinable from the prompt.
What due diligence normally checks
To assess supply concentration, procurement teams review:
- manufacturing site redundancy
- alternate sterilization lines
- change control history
- FDA inspection/483 patterns tied to sites
This requires site-identified manufacturing records.
Key Takeaways
- VALSTAR Preservative Free supplier mapping requires NDC-specific FDA labeler and manufacturing-site data.
- The prompt does not provide the NDC(s), NDA number, labeler/holder, or manufacturer-site listings needed to generate a factual supplier roster.
- No definitive supplier list, contract manufacturer identification, or distributor network can be produced without those inputs.
FAQs
- How can I identify the manufacturer behind a specific VALSTAR Preservative Free NDC?
- Where do I find the contract manufacturing site details for preservative-free ophthalmic products in FDA records?
- Do VALSTAR Preservative Free generics exist, and do they change supply options for buyers?
- What sourcing documents do hospitals request for ophthalmic single-dose preservative-free products?
- How do Orange Book patent expiration dates impact availability of preservative-free betaxolol ophthalmic substitutes?
References
No cited sources available because the prompt does not include any product identifiers or FDA records to support a factual supplier analysis.
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