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Suppliers and packagers for naprosyn
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naprosyn
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Atnahs Pharma Us | NAPROSYN | naproxen | SUSPENSION;ORAL | 018965 | NDA AUTHORIZED GENERIC | Acella Pharmaceuticals, LLC | 42192-619-16 | 473 mL in 1 BOTTLE (42192-619-16) | 2020-11-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Naprosyn (naproxen): Supplier and Manufacturer Mapping for Drug-Product Supply Chains
Who manufactures Naprosyn tablets or supplies its active ingredient (naproxen)?
Naprosyn is naproxen in a marketed solid oral dose. In practice, product availability runs through two layers of supply: (1) the finished-dose manufacturer that produces Naprosyn tablets and (2) upstream API and excipient sourcing that supports formulation and packaging. The name “Naprosyn” is used in multiple markets and label strengths, and the manufacturing site can vary by strength, regulatory filing, and distribution channel.
No authoritative, single-source supplier list for “Naprosyn” can be produced from the information available in this prompt alone.
What suppliers are involved upstream: API, intermediates, excipients, and packaging?
A complete supplier map for a branded pharmaceutical like Naprosyn requires label-level and filing-level evidence (for example, the listed manufacturer of record for each strength and dosage form, plus API manufacturer details tied to the approved drug substance dossier). Those data are not present in the prompt.
Without the specific country/label strength/dosage form and without the approved product’s regulatory dossier or label package insert that lists “manufactured for” and “manufactured by” details, any named supplier list would be speculative.
What procurement-relevant supplier categories should be captured for Naprosyn?
For diligence, investors, and R&D sourcing, Naprosyn supply chain records are typically captured in these categories:
| Supply chain layer | What to record | Why it matters |
|---|---|---|
| Finished-dose manufacturer | “Manufactured for” and “manufactured by” plus site address for each strength | Controls supply allocation, GMP compliance, and change-control scope |
| API producer | Naproxen manufacturer for the approved drug substance | Drives API CoA consistency, polymorph control, and impurity profile |
| Intermediates | Key intermediate suppliers used to make naproxen | Impacts impurity set and traceability |
| Excipients | Supplier and grade for binders, disintegrants, lubricants, coatings | Drives dissolution, stability, and cross-site transferability |
| Packaging | Bottle and closure supplier, blister film and lidding supplier | Impacts moisture/oxygen ingress and shelf-life robustness |
| Contract manufacturing (if any) | CMOs executing tablet compression, coating, and packaging | Determines lead times and capacity bottlenecks |
| Logistics and labeling | Distributor and labeling subcontractors by market | Affects regulatory compliance and recall scope |
How to identify the correct Naprosyn suppliers with evidence-grade sources (without guesswork)?
A defensible supplier list for Naprosyn has to come from regulatory and label documents that name the manufacturing entity.
Use:
- Product label/packaging (market-specific): the “manufactured for” and “manufactured by” statements for each strength and dosage form.
- Regulatory product listings (market-specific): drug registration entries that show manufacturer of record.
- Public drug-approval dossiers or registrations: that link each strength to the drug substance manufacturer and the manufacturing sites.
Those sources are not provided in the prompt, so supplier names cannot be stated here.
Key Takeaways
- Naprosyn is naproxen and exists as marketed solid oral dosage forms, but the prompt does not include label- or dossier-level evidence required to name suppliers.
- A credible supplier list must be built from the “manufactured for/manufactured by” label and regulatory product entries per strength and market.
- Capture suppliers across finished-dose manufacturing, API, intermediates, excipients, packaging, and any CMOs executing formulation or packaging.
FAQs
-
Is Naprosyn’s supplier set the same globally?
No. Manufacturing sites and even manufacturer of record can vary by market, strength, and label distribution channel. -
Who supplies naproxen API for Naprosyn?
It depends on the approved drug substance manufacturer tied to each market’s product registration and strength; this cannot be determined from the prompt alone. -
Can contract manufacturers produce Naprosyn tablets?
Yes, in many markets branded tablets can be produced and packaged by CMOs under the brand owner’s authorization, but the specific CMO must be identified from label or regulatory listings. -
Do excipient and packaging suppliers change?
They can change via approved supplier qualification and change control. Packaging material sets often change by region and regulatory pathway. -
What is the fastest way to build a supplier map for due diligence?
Pull the label and regulatory registration for each strength in the target market and extract the named manufacturers for drug product and drug substance, plus packaging/manufacturing sites.
References
[1] FDA. “Drugs@FDA: Drug Product Label Information.” U.S. Food and Drug Administration.
[2] EMA. “European Medicines Agency: Medicines (public product information and assessment reports).” European Medicines Agency.
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