Suppliers and packagers for EXTENDED PHENYTOIN SODIUM

EXTENDED PHENYTOIN SODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms Ny	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040765	ANDA	DIRECT RX	61919-815-30	30 CAPSULE in 1 BOTTLE (61919-815-30)	2014-01-01
Amneal Pharms Ny	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040765	ANDA	DIRECT RX	61919-815-71	100 CAPSULE in 1 BOTTLE (61919-815-71)	2014-01-01
Amneal Pharms Ny	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040765	ANDA	DIRECT RX	61919-815-72	120 CAPSULE in 1 BOTTLE (61919-815-72)	2014-01-01
Amneal Pharms Ny	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040765	ANDA	Amneal Pharmaceuticals LLC	65162-212-03	30 CAPSULE in 1 BOTTLE (65162-212-03)	2009-12-16

Extended Phenytoin Sodium Suppliers: Manufacturers, Labelers, and Sourcing Risks for the US Market

Last updated: June 12, 2026

Extended phenytoin sodium (often marketed as extended-release phenytoin sodium tablets) is supplied through a small set of global specialty generic and branded manufacturers. In the US, “supplier” effectively means (1) the firms that manufacture the extended-release dosage form, (2) the firms that market under the NDC labeler name, and (3) the API and finished-dose supply chain structure (including tolling) that determines batch availability.

Actionable result: This sourcing landscape is controlled by (a) API procurement for phenytoin sodium, (b) formulation and scale-up capability for controlled-release matrices, (c) finished-goods release under CGMP, and (d) FDA product-specific compliance (inspection history, site ownership changes, and market withdrawals).

Who supplies extended phenytoin sodium in the US (finished-dose manufacturers)?

Direct finished-dose supplier set is identified through the NDC labeler plus the underlying manufacturer of record on US FDA product listings. Extended-release phenytoin sodium products typically show multiple labelers over time while one or a few manufacturing sites make the tablets under contract or for multiple brands.

Typical supplier roles in extended-release phenytoin sodium

• API supplier: manufacturer of phenytoin (conversion to sodium salt happens in formulation steps or during salt formation, depending on site process).
• Formulation and tableting manufacturer: creates the extended-release tablet (matrix design, granulation, compression, coating if applicable).
• Packaging and distribution: secondary packaging and NDC assignment under labeler control.

How to map “supplier” to real contracting entities

For procurement and contingency planning, treat “supplier” as the intersection of:

1. NDC labeler name (who sells to wholesalers),
2. Manufacturer of record (CGMP site releasing product),
3. Dispensing channel (wholesale vs hospital distribution),
4. Supply continuity (site changes, product discontinuations, short-dated inventory patterns).

What API suppliers support phenytoin sodium extended-release formulations?

Most extended-release phenytoin sodium tablets rely on commercially available phenytoin (free base) as the starting material, then convert/ensure the correct salt state in manufacturing. API sourcing is usually concentrated in a limited number of chemical producers given the mature, low-to-mid complexity API.

API sourcing drivers

• Quality system controls for polymorph and particle characteristics affecting tablet release
• Consistency in impurity profile (phenytoin degradation-related impurities)
• Supply reliability during intermediate chemical shortages

Common procurement risk patterns

• API lead time increases due to synthesis/intermediate bottlenecks
• Batch rejections caused by impurity or particle-size excursions that affect extended-release performance

Which companies manufacture extended phenytoin sodium tablets (brand vs generic)?

Extended-release phenytoin sodium in the US is predominantly generic, with periodic branded presence depending on historical product lines and labeler changes. Supplier names change when:

• a product transfers to a different CGMP site,
• a company exits the market or sells its product portfolio,
• a product is made under license by another manufacturer.

How to structure a supplier short list for procurement

Use three tiers:

1. Primary commercial supplier (current manufacturer of record for the largest-selling NDCs)
2. Secondary contingency suppliers (other NDCs with same dosage strength that can substitute)
3. Tertiary sourcing via labeler switching (same tablet made at a different site but marketed under different NDCs)

What dosage strengths and dosage forms exist for extended phenytoin sodium sourcing?

For procurement and substitution planning, confirm exact strength and release characteristics. Extended-release phenytoin sodium is commonly sold in tablet form in multiple strengths (most commonly seen as 100 mg and/or 200 mg tablets depending on product line).

Why strength-level matching matters

• Extended-release performance depends on the formulation recipe and tablet size
• Substitution across strengths is not always interchangeable clinically
• FDA “sameness” requires matching strength, dosage form, and release characteristics

How does FDA listing and Orange Book status affect who can supply extended phenytoin sodium?

Extended-release phenytoin sodium products can be constrained by:

• drug product exclusivities and patents listed in the Orange Book (where applicable)
• therapeutic equivalence and manufacturing/labeling approvals

Practical impact on supplier options

• If a specific NDC is tied to limited manufacturing capacity or site ownership constraints, shortages propagate quickly.
• Patent-protected labeling claims can delay generic supply for a period, even when the active ingredient is off-patent.

Which suppliers face the highest risk of shortages or allocation?

Sourcing risk concentrates in:

• one-site products with no licensed backup manufacturing site,
• products dependent on a specific extended-release matrix design,
• supply chains with long API lead times.

Allocation indicators to watch

• Persistent backorders in wholesale channels
• Short-dated inventory patterns
• Recalls linked to stability, coating, or dissolution failures

How strong is the IP and regulatory barrier to new suppliers?

Extended-release phenytoin sodium is an older, widely used therapy. The regulatory barrier for new entrants is usually more about manufacturing and bioequivalence evidence than about novel science.

Key barriers for a new tablet supplier

• Establishing a controlled-release dissolution profile consistent with approved reference products
• Demonstrating bioequivalence for each strength
• Passing site inspections for CGMP and data integrity

What generic entry risks exist for extended phenytoin sodium?

Generic entry risk is typically low for the active ingredient but moderate for:

• specific release technology if the reference product is protected,
• product-specific formulation patents or method-of-use claims tied to labeling.

Where delays show up in practice

• NDA supplements requiring new dissolution specs
• Changes in manufacturing site or equipment requiring comparability protocols

What manufacturing/IP barriers complicate switching suppliers?

Switching suppliers is rarely “drop-in” unless the product is therapeutically equivalent and meets the same release profile.

Barriers by category

• Formulation comparability: different matrix/coating designs can alter dissolution and in vivo exposure
• Equipment differences: compression rates and granulation parameters affect release
• Quality release specs: tighter controls for impurities and dissolution

Supplier due diligence checklist for procurement of extended phenytoin sodium

Use the checklist below to qualify and reduce shortage exposure:

1. NDC-to-manufacturer mapping: verify manufacturer of record and current CGMP site
2. Batch release consistency: review historical COAs and dissolution/bioequivalence alignment documentation
3. Supply continuity: confirm if the product is made at more than one site
4. Regulatory status: confirm no recent enforcement actions tied to the site or product
5. API continuity: confirm whether API is dual-sourced or single-sourced

Key Takeaways

• Extended phenytoin sodium sourcing is driven by a limited set of CGMP tablet manufacturing sites and the API supply chain for phenytoin.
• “Supplier” in procurement should be treated as the manufacturer of record plus the NDC labeler, not the brand name alone.
• Risk of allocation is highest where the finished product is effectively single-site and depends on constrained API/extended-release manufacturing capacity.
• Supplier switching requires strength and release-characteristic matching and confirmation of therapeutic equivalence.

FAQs

Which NDC labeler suppliers currently sell extended phenytoin sodium?

NDC labeler names vary by strength and time; the reliable method is to map each NDC to its manufacturer of record via FDA product listing.

Can wholesalers substitute one extended-release phenytoin sodium tablet strength for another?

Substitution is strength- and product-specific; confirm therapeutic equivalence and release characteristics for the specific NDC.

What are the most common causes of extended-release phenytoin sodium supply interruptions?

Single-site manufacturing constraints, API lead-time disruptions, and quality failures tied to dissolution or stability specs.

Do extended-release phenytoin sodium products have Orange Book listed patents that affect generic availability?

Some products may have listed patents or exclusivities that constrain label and/or generic entry timing, depending on the specific NDC product.

What due diligence materials should a buyer request from a new supplier?

COAs for recent batches, evidence of dissolution performance against approved specs, CGMP site identity, and supply continuity plan tied to the manufacturer of record.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-06-13).