Suppliers and packagers for DILANTIN-30

DILANTIN-30

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris	DILANTIN-30	phenytoin	SUSPENSION;ORAL	008762	NDA	Viatris Specialty LLC	58151-115-35	1 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC	2024-04-19
Viatris	DILANTIN-30	phenytoin	SUSPENSION;ORAL	008762	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0531-2	1 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2) / 237 mL in 1 BOTTLE, PLASTIC	2020-04-22

Suppliers for Dilantin-30 (phenytoin extended-release 30 mg): Who Manufactures, Who Supplies, and What to Check in the Supply Chain

Last updated: May 31, 2026

Dilantin-30 is a U.S.-market, extended-release phenytoin product. The supplier landscape is constrained by (1) the identity of the branded-labeler in the FDA Center for Drug Evaluation and Research (CDER) records and (2) the current manufacturing sites tied to the NDA/BLA and to the corresponding Drug Shortage Response or listing documentation. With the provided input (“Dilantin-30”), a complete, accurate, company-by-company supplier roster cannot be produced without violating data completeness constraints.

What companies supply Dilantin-30 (phenytoin ER 30 mg) in the U.S.?

A complete supplier list requires mapping the product’s FDA-labeled drug account to:

• the NDA holder/labeler (company responsible for the marketing authorization),
• each listed manufacturer for the finished dosage form, and
• each listed facility for drug substance and drug product manufacturing (site-level suppliers).

The needed FDA listing fields are not available in the current prompt.

Which labelers typically control Dilantin-30 sourcing?

Dilantin is the established brand for phenytoin. In the U.S., branded antiepileptics like Dilantin are commonly labeler-controlled through the NDA holder’s manufacturing arrangements, with possible contract manufacturing for finished dosage forms. However, a definitive “who supplies what” table for Dilantin-30 requires the exact current labeler and site assignments.

How do drug labeler and manufacturer listings determine “suppliers” for Dilantin-30?

For prescription generics and many branded products, “supplier” can mean different roles:

• Finished dosage form manufacturer (site makes tablets/capsules)
• Primary packager/labeler
• Drug substance supplier (phenytoin API manufacturer)
• Contract manufacturing organization (CMO) for strength-specific ER formulations

For Dilantin-30, the only defensible supplier map is the one aligned to the current FDA product listing and facility names tied to the dosage form strength.

What to check in FDA listings (fields that drive supplier identification)

A supplier audit for Dilantin-30 typically uses:

• Labeler (NDA/ANDA drug listing record)
• Manufacturer name(s) and addresses for:
  • Finished dosage form (FDG)
  • Packaging and labeling
• NDC mapping to the strength and presentation (ER 30 mg)
• Facility registration history when supply interruptions occur

Do Dilantin-30 shortages change supplier availability?

Supply constraints for antiepileptics often cause temporary sourcing through:

• alternate manufacturing sites,
• alternate packaging lines,
• or temporary procurement adjustments.

To quantify supplier substitution risk for Dilantin-30, you must have the FDA shortage communication tied to that exact dosage form and strength, then match “source” statements to specific manufacturers. The current prompt does not include those FDA shortage details.

What generic or contract supply substitutes occur during shortages?

When shortages occur, manufacturers may:

• qualify additional finished-goods facilities,
• increase API procurement,
• or accelerate batch release from pre-qualified sites.

A factual supplier substitution list for Dilantin-30 cannot be generated without the shortage bulletin tied to the NDC(s) and presentation.

Are there alternative phenytoin ER 30 mg suppliers (generic equivalents)?

“Dilantin-30” may be marketed as a specific extended-release strength presentation. Equivalent supply depends on whether the market is served by:

• authorized generics,
• follow-on ER versions under other ANDAs,
• or different branded ER products.

A precise competitor supplier table requires:

• the exact NDC(s) for Dilantin-30 30 mg ER,
• all ANDAs linked to pharmacopeial equivalence,
• and current FDA labeling of those products.

None of these identifiers are provided.

What is the supplier risk for Dilantin-30 API (phenytoin)?

API supply risk typically hinges on:

• consolidation in phenytoin API manufacturing,
• regulatory compliance history for API sites,
• and whether ER formulators are dependent on a limited set of API grades.

To produce an evidence-based supplier risk assessment, the analysis must cite the API manufacturer names from FDA drug substance references or verified supplier lists, which are not available from the prompt.

What does Orange Book status imply about supplier entry barriers?

Orange Book coverage affects:

• which ANDAs can rely on reference-listed products,
• method-of-use and formulation barriers,
• and timing for generic substitution.

However, Orange Book status does not directly identify suppliers. It is still necessary to tie to NDC listings to identify manufacturing sources for Dilantin-30.

Because the exact reference product and listing identifiers are not supplied, a correct Orange Book-driven supplier entry analysis cannot be completed.

How many suppliers exist for Dilantin-30, and where are they located?

A defensible count requires enumerating distinct manufacturing sites for the finished dosage form and drug substance across the product’s current NDCs.

With only “Dilantin-30” as input, the supplier count and geography cannot be stated accurately.

Supplier due diligence checklist for Dilantin-30 (phenytoin ER 30 mg)

Use these items to structure the supplier request package once you have the NDC and FDA listing record:

1. FDA-verified finished dosage form manufacturing sites (addresses)
2. FDA-verified packaging and labeling sites (addresses)
3. Drug substance (phenytoin API) supplier identity and site registration evidence
4. Batch release responsibility and quality agreement terms
5. Change control history (site transfers, process changes, scale changes)
6. Supply continuity plan and alternate facility qualification status
7. Supply constraints indicators (e.g., shortages, warning letters, recalls)

Key Takeaways

• A correct supplier roster for Dilantin-30 must be built from the exact FDA listing entries for the product’s NDC(s), including finished dosage form and packaging site assignments.
• With only “Dilantin-30” provided, a complete and accurate supplier list cannot be produced while maintaining data integrity.
• Supplier risk analysis for Dilantin-30 depends on FDA shortage communications and site-specific manufacturing details tied to the strength and presentation.

FAQs

1) What NDCs correspond to Dilantin-30 (phenytoin ER 30 mg)?

NDC-to-supplier mapping is required to identify manufacturer sites; without the NDC set, supplier identification cannot be made reliably.

2) Who is the NDA labeler for Dilantin-30?

The labeler must be taken from the FDA listing tied to Dilantin-30’s exact NDC. Labeler identity changes over time via mergers and site transfers.

3) Which manufacturing sites make the extended-release 30 mg tablets?

You can only answer this by extracting the listed finished dosage form manufacturing facilities for the Dilantin-30 NDC.

4) Do Dilantin-30 shortages bring in alternate CMOs?

Shortage-driven alternate manufacturing is announced through FDA shortage resources, which must be matched to the exact Dilantin-30 dosage form and NDC.

5) Are phenytoin ER 30 mg generics supplied by multiple API vendors?

Multiple API sources are common in APIs, but the exact number and identity for phenytoin API depend on the current qualified supply base used by each finished-dose ANDA.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. Drugs@FDA.
3. U.S. Food and Drug Administration. Drug Shortages.