SUMATRIPTAN AND NAPROXEN SODIUM: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	207457	ANDA	Aurobindo Pharma Limited	65862-928-36	9 TABLET, FILM COATED in 1 BOTTLE (65862-928-36)	2018-02-15
Sun Pharm	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	202803	ANDA	NorthStar RxLLC	16714-891-01	9 TABLET, FILM COATED in 1 BOTTLE (16714-891-01)	2018-11-27
Sun Pharm	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	202803	ANDA	Sun Pharmaceutical Industries, Inc.	47335-410-22	9 TABLET, FILM COATED in 1 BOTTLE (47335-410-22)	2018-07-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Sumatriptan and Naproxen Sodium suppliers: who manufactures the APIs, finished dosage forms, and contract supply in the US and globally

Executive summary: The supply chain for sumatriptan (tablet, injection, and nasal spray variants depending on label) and naproxen sodium (immediate-release and prescription/OTC strengths) relies on a mix of API manufacturers, CDMOs for oral solids, and fill-finish/sterile operations for injection. Supplier lists are typically captured in US FDA drug master files (DMFs) and Orange Book-linked manufacturers for each NDA/ANDA. Without those case-specific FDA filings for the exact branded products and strengths, the only accurate supplier view is structural: where suppliers sit (API vs finished dose), how many supplier classes exist, and what documents to use to pinpoint named firms.

What suppliers provide sumatriptan and naproxen sodium, and where do they sit in the value chain?

Short answer: Suppliers break into (1) sumatriptan API and (2) naproxen sodium API, plus (3) finished-dose manufacturing (oral solids) and (4) sterile fill-finish for sumatriptan injection.

Sumatriptan supply chain map

API suppliers (sumatriptan base/salt):
- Provide commercial API to tablet and nasal spray producers.
- Often listed indirectly through DMFs (API manufacturer of record) tied to an NDA/ANDA.
Finished-dose manufacturers:
- Oral tablets: typically handled by oral solid CDMOs and/or branded manufacturers.
- Nasal spray: requires formulation development plus spray system filling/assembly.
- Injection: requires sterile manufacturing and aseptic fill-finish (vial/syringe).

Naproxen sodium supply chain map

API suppliers (naproxen sodium salt):
- Provide naproxen sodium API to immediate-release tablet producers and combination products.
Finished-dose manufacturers:
- Generally oral solid operations (compression, coating, packaging).
- Bioequivalence and stability performance drive selection of site and formulation partners.

Which patents and Orange Book listings determine the exact “allowed” suppliers for sumatriptan and naproxen sodium?

Short answer: The practical supplier set is constrained by what is marketed (Orange Book NDA/ANDA) and what is licensed (authorized generics, label holdings, and any distribution agreements). Patent and exclusivity status drives who can legally supply a given strength/form at scale.

Orange Book and exclusivity as a supplier filter

For any specific strength and dosage form, the supplier universe can be limited to:

Orange Book NDA label holders (branded product manufacturers)
ANDA applicants and manufacturers (generic/authorized generic)
Licensed distributors that contract with specific manufacturing sites

Patent estate and supply

Where patents remain in force, supply tends to concentrate with:

The NDA holder and
Any authorized generic partners with licenses

When patents expire, ANDA supply generally broadens across CDMOs and multiple API sources.

Who makes sumatriptan APIs and naproxen sodium APIs for generic and branded products?

Short answer: API manufacture is concentrated among established chemical suppliers with DMFs. The named firms depend on the specific DMF referenced for each NDA/ANDA.

API sourcing patterns common to both actives

Multiple API sources may exist for the same salt form, but only some are qualified for a given applicant’s regulatory dossier.
Applicants typically select API suppliers based on:
- DMF acceptance and regulatory history
- impurity profile controls
- supply continuity and route-of-synthesis comparability
- compliance record for inspections

What to check to name the actual suppliers

To convert “API supplier classes” into a named supplier list, the actionable sources are:

FDA DMF database (API manufacturers tied to each drug application)
Orange Book manufacturer section for each dosage form/strength
FDA inspection lists where relevant to the manufacturing sites

(Without the exact NDA/ANDA numbers and dosage forms in scope, supplier names cannot be stated accurately.)

Which companies supply finished tablets, injections, and nasal sprays for sumatriptan?

Short answer: Finished-dose supply for sumatriptan is split by dosage form:

Oral tablets: oral solid manufacturing plants and CDMOs.
Nasal spray: nasal spray formulation and assembly specialists.
Injection: sterile fill-finish and vial or prefilled syringe capacity.

Injection-specific supplier requirements

Sumatriptan injection supply typically requires:

aseptic processing and environmental controls
sterilizing-grade filtration compatibility
container closure compatibility studies
batch record compliance for sterile products

These constraints often limit the supplier set to fewer sterile CDMOs with proven track record.

What are the major manufacturing and regulatory documents that show the “real” suppliers?

Short answer: The supplier names you can rely on appear in Orange Book and FDA DMFs.

Core documents to extract suppliers

Orange Book for each active ingredient, strength, dosage form, and applicant
DMFs for API manufacturing site and holder
Labeler/manufacturer sections for packaged product entities
FDA inspection outcomes for manufacturing sites (where publicly reflected)

When can new suppliers enter the market for sumatriptan + naproxen sodium combinations?

Short answer: Entry timing is product-specific and driven by:

listed patents expiring on specific dates
regulatory exclusivity windows
ANDA approval timelines and any litigation settlements for the particular NDA/ANDA

What controls “generic entry risk”

Remaining blocking patents can delay ANDA launches even after approvals.
Patent settlement terms can restrict supply calendars or allow only one or two approved launchers.

(Exact timelines require product-level patent and litigation mapping.)

How does biosimilar risk apply to sumatriptan and naproxen sodium?

Short answer: It does not. Both are small-molecule drugs, so the supply and entry framework is ANDAs rather than biosimilars.

How do formulation patents affect supplier selection for naproxen sodium?

Short answer: Formulation and manufacturing process patents do not block supply in the way biologics do, but they can:

narrow eligible applicants
require specific formulation approaches to achieve bioequivalence
increase CDMO development timelines for oral solids

Key formulation supplier constraints for naproxen sodium

dissolution performance for immediate-release tablets
excipient compatibility
stability and impurity control
scale-up robustness for compression and coating

What commercial supplier strategies do manufacturers use for sumatriptan and naproxen sodium?

Short answer: Suppliers are managed through multi-source API qualification and multiple-site packaging/manufacturing plans to reduce shortage risk.

Common supplier strategy patterns

Dual-source API qualification to reduce single-site disruption risk
Contract manufacturing for surge capacity (oral solids)
Dedicated sterile capacity scheduling for injection
Consolidation around plants with lower inspection risk profiles

Key Takeaways

Supplier ecosystems for sumatriptan and naproxen sodium are best mapped by API DMFs plus Orange Book manufacturer entries for each exact dosage form and strength.
Sumatriptan supply splits by dosage form: oral solids, nasal spray, and sterile injection, with sterile fill-finish typically limiting supplier count.
Naproxen sodium supply is mainly oral solid manufacturing, with key differentiators in dissolution, stability, and excipient/process controls.
Named supplier identification requires product-specific regulatory linkages (NDA/ANDA + DMF/Orange Book manufacturer entries). Without those identifiers for the exact formulations, only the value-chain structure can be stated accurately.

FAQs

How can I find the named API suppliers for sumatriptan in the US? Use the FDA Orange Book listing for the specific sumatriptan dosage form/strength and cross-reference the linked DMF holders for that application.
Are there multiple API sources for naproxen sodium, and how do applicants qualify them? Yes, but only sources referenced in the applicant’s regulatory dossier are guaranteed for substitution without additional filings.
Which step is most capacity-constrained for sumatriptan injection supply? Sterile manufacturing and aseptic fill-finish, including container closure compatibility and sterility assurance.
Do formulation patents for naproxen sodium limit generic entry? They can, by requiring specific process or formulation approaches to maintain bioequivalence and avoid infringement.
Does biosimilar regulation affect sumatriptan or naproxen sodium suppliers? No. Both are small molecules, so supplier entry is governed by ANDA pathways rather than biosimilar rules.

References

U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (FDA).
U.S. Food and Drug Administration. Drug Master Files (DMF) database. (FDA).

Suppliers and packagers for SUMATRIPTAN AND NAPROXEN SODIUM