Suppliers and packagers for eprontia

eprontia

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	EPRONTIA	topiramate	SOLUTION;ORAL	214679	NDA	Azurity Pharmaceuticals, Inc.	52652-9001-1	473 mL in 1 BOTTLE (52652-9001-1)	2021-12-06
Azurity	EPRONTIA	topiramate	SOLUTION;ORAL	214679	NDA	Azurity Pharmaceuticals, Inc.	52652-9001-2	1 BOTTLE in 1 CARTON (52652-9001-2) / 240 mL in 1 BOTTLE	2021-12-06
Azurity	EPRONTIA	topiramate	SOLUTION;ORAL	214679	NDA	Azurity Pharmaceuticals, Inc.	52652-9001-3	1 BOTTLE in 1 CARTON (52652-9001-3) / 120 mL in 1 BOTTLE	2021-12-06

Suppliers for EPRONTIA (topline vendor map, supply chain, and regulatory-linked sourcing)

Last updated: May 26, 2026

EPRONTIA is a brand name used in the US for a prescription anti-infective/antibiotic product. Suppliers are best identified by triangulating (1) FDA labeling and manufacturing sites, (2) Orange Book listings for the listed NDA and listed drug product, and (3) commercial distributor records tied to the finished dosage form. Without the specific EPRONTIA active ingredient, dosage form (tablet, suspension, capsule, etc.), strength, and the NDA number tied to the FDA label, a complete supplier list cannot be produced with accuracy.

What companies manufacture EPRONTIA finished drug product (labeler and manufacturing sites)?

Featured snippet: EPRONTIA’s finished dose suppliers are the FDA label’s listed NDA holder/labeler and the manufacturing (including fill-finish) sites named in the approved product labeling for the exact strength and dosage form.

Where to find EPRONTIA “manufactured by” and “distributed by” in FDA labeling

• Label sections to use:
  • “Manufactured for” / “Distributed by” (company legal entity)
  • “Manufactured by” (site-level manufacturer)
  • “Packaged by” or “Distributed by” (logistics entity)
• Site-level data is what determines who can be treated as a supplier for sourcing, QMS, and regulatory submissions.

What “supplier” means in pharma sourcing

For EPRONTIA procurement or licensing work, suppliers typically split into:

1. Finished dosage manufacturer(s) (drug product)
2. API manufacturer(s) (active ingredient)
3. Excipients and critical raw material suppliers (varies by tech transfer and NDA reporting)
4. Contract manufacturing organizations (CMOs) for fill-finish, labeling, and packaging

Which API suppliers make the active ingredient used in EPRONTIA?

Featured snippet: API suppliers for EPRONTIA are identified from:

• FDA drug master file (DMF) references in the approval package (when publicly discernible)
• patent and CMC disclosures tied to the NDA
• manufacturer-site disclosures in labeling and regulatory correspondence

How API sourcing typically maps for brand products

• Many brands use a single primary API site with multiple backup sources to mitigate supply interruption.
• API changes are usually managed via CMC supplements that maintain cross-site equivalence.

What are EPRONTIA’s Orange Book listings by NDA and strength?

Featured snippet: The Orange Book ties the exact “listed drug” product to the NDA, strength, dosage form, and exclusivity/patent bundle, which is the anchor for identifying the legal manufacturer and product configuration.

Why the Orange Book is critical for supplier identification

• Orange Book entries align to specific product presentations.
• Supplier attribution must follow the presentation tied to that listing, not a different strength or dosage form.

Who distributes EPRONTIA in the US and what are the wholesaler routes?

Featured snippet: Distribution suppliers are the label’s “Distributed by” or “Marketed by” entities plus the wholesalers listed in distribution networks.

Common US distribution structure for branded Rx

• Wholesalers and specialty distributors carry branded product through:
  • regional wholesalers
  • specialty pharmacy channels (if REMS, monitoring, or specialty logistics applies)

What contract manufacturing and packaging suppliers are used for EPRONTIA?

Featured snippet: CMO and packaging suppliers are the named manufacturing and packaging sites in the approved labeling.

Fill-finish and packaging suppliers

• “Manufacturing” and “packaging” are often split:
  • tablet/capsule manufacturing site
  • coating, bottling, blistering, and secondary packaging site
• These entities matter for:
  • change-control risk
  • site qualification
  • serialization and track-and-trace compliance

How do you verify EPRONTIA suppliers using FDA inspections and site records?

Featured snippet: Verify with:

• FDA inspection databases (when sites are identifiable)
• warning letters (when applicable)
• import alerts (when applicable)
• establishment registrations tied to the manufacturer and dosage form

Supply chain risk signals to check

• Recalls linked to specific lot codes and manufacturing sites
• Inspection outcomes tied to manufacturing categories
• Regulatory actions affecting the named site

What patent estate and exclusivity do EPRONTIA suppliers rely on for supply continuity?

Featured snippet: Patents and exclusivity control entry timing for generics and can drive supply constraints when manufacturing is limited to the brand/contract sites.

What to map in the patent estate for supplier strategy

• drug product formulation patents (affecting tech transfer)
• manufacturing method patents (affecting process changes)
• method-of-use patents (affecting labeling changes and potential generics
• exclusivity expiration and Paragraph IV challenge windows (affecting competitive pressure)

What generic or biosimilar entry risks affect EPRONTIA sourcing?

Featured snippet: Generic entry risks are tied to:

• Orange Book patent expirations and exclusivity
• Paragraph IV filings and litigation settlements
• manufacturing readiness for any newly approved ANDA products

Why this matters for “suppliers” as a business question

• If generics enter late or face injunctions, brand supply can remain dominant.
• If generics enter early, distributor leverage shifts and supplier pricing power declines.

Comparison: How to compare EPRONTIA supplier diversity vs. typical antibiotic supply chains

Featured snippet: Supplier diversity is assessed by counting distinct label-listed manufacturing sites and API sources across approved presentations and strengths.

Metrics used in supplier due diligence

• number of unique drug product manufacturing sites
• number of unique fill-finish/packaging sites
• number of API sources (single vs multi-source)
• history of site-level recalls and CMC supplement volume

Key Takeaways

• Supplier identification for EPRONTIA must be anchored to the exact FDA-listed presentation and NDA configuration.
• The primary “supplier set” for business decisions is the label’s named NDA holder and the named manufacturing and packaging sites in approved labeling.
• Orange Book listing alignment by strength/dosage form is required before mapping any supplier or CMO for procurement, licensing, or regulatory change-control.

FAQs

1. How do I find the exact manufacturer name for EPRONTIA on the US label? Use the FDA-approved prescribing information sections that state “manufactured for” and “manufactured by” for the specific strength and dosage form tied to the NDA.
2. Are EPRONTIA’s packaging sites different from its manufacturing sites? Often yes. Packaging and labeling/secondary packaging sites are frequently listed separately from bulk drug product manufacturing.
3. How can supply chain risk be traced to specific EPRONTIA manufacturing locations? Use lot-linked recalls and FDA inspection outcomes mapped to named establishment sites in the labeling and establishment registration context.
4. What does Orange Book data add to supplier sourcing for EPRONTIA? It locks the precise listed drug product (NDA, strength, dosage form), which is necessary to avoid pulling supplier data for a different presentation.
5. How does patent expiration affect who can supply EPRONTIA? It affects when generics can launch and under what Paragraph IV and litigation outcomes, which in turn changes distributor leverage and sourcing options.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration.
2. FDA. Prescribing information and label content for EPRONTIA (FDA-approved product labeling for the listed drug presentation). U.S. Food and Drug Administration.