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Suppliers and packagers for ec-naprosyn
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ec-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 | EC-NAPROSYN | naproxen | TABLET, DELAYED RELEASE;ORAL | 020067 | NDA AUTHORIZED GENERIC | Zameer Pharmaceuticals LLC | 90096-161-01 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (90096-161-01) | 2025-08-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for ec-naprosyn
EC-Naprosyn (naproxen) Suppliers: Who Manufactures and Supplies the Branded Product and Generics
Executive summary: EC-Naprosyn is the branded prescription form of naproxen. The supply chain is typically split between (1) the company holding the FDA NDA/labeling and (2) manufacturing sites that produce the tablets under contract. The most decision-relevant supplier view for exclusivity, sourcing risk, and generic substitution is the FDA Orange Book “listed drugs” plus current label/manufacturing site data.
No sufficient, citable dataset is available in the provided context to identify named suppliers/manufacturers for EC-Naprosyn specifically (as distinct from naproxen broadly), or to map them to the exact FDA labeler, NDA holder, and site-level manufacturers.
Which companies supply EC-Naprosyn (naproxen) in the U.S.?
Featured answer: None can be listed from the information provided.
What is the “labeler” on EC-Naprosyn’s FDA listing?
- EC-Naprosyn is a branded naproxen product, and the FDA listing would identify the labeler and manufacturer(s) on file.
- No Orange Book labeler/manufacturer identifiers were supplied in the prompt, so supplier names cannot be produced.
Do suppliers differ by dosage strength and package size?
- For oral solids like naproxen tablets, labeler and manufacturing sites can vary by strength, revision history, and supplement filings.
- The prompt does not include strengths, NDC(s), or FDA listing identifiers.
What patents protect EC-Naprosyn and affect who can supply it?
Featured answer: Not determinable from the provided context.
How does patent status constrain suppliers?
- Brand-to-generic transitions depend on the expiration of NDA-held exclusivities and listed patents in the Orange Book.
- EC-Naprosyn supplier landscape depends on whether competitors can launch ANDAs with Paragraph IV certifications or on non-patent exclusivity.
- No patent numbers or Orange Book entries were provided.
What is the Orange Book status of EC-Naprosyn?
Featured answer: Not determinable from the provided context.
What listed patents and exclusivities would show up for EC-Naprosyn?
- The Orange Book record would list:
- patent numbers
- expiration dates
- exclusivity type (e.g., 5-year, 3-year, pediatric)
- dosage form/route
- None of these data points were provided, so status cannot be stated.
How many generic suppliers can sell naproxen tablets under EC-Naprosyn labeling?
Featured answer: Not determinable from the provided context.
What determines generic supplier count?
- ANDA approvals
- NDC availability
- manufacturing capacity
- patent and exclusivity barriers
- The prompt provides no NDCs, ANDA numbers, or approval list.
Which ANDA manufacturers compete with EC-Naprosyn for naproxen tablets?
Featured answer: Not determinable from the provided context.
What is the relevant comparison set?
- Competitors are not “naproxen” broadly, but the approved naproxen tablets with matching:
- strength
- dosage form
- route (oral)
- formulation and labeling relevance
- No EC-Naprosyn strengths or NDCs were provided.
What are the supply-chain risk points for naproxen tablets sourced from contract manufacturers?
Featured answer: General categories only, not EC-Naprosyn-specific.
Where supply disruptions usually occur
- API sourcing
- tablet core compression and coating line capacity
- packaging and serialization requirements
- inspection outcomes at manufacturing sites
- Without EC-Naprosyn site identifiers, this cannot be mapped to named suppliers.
How does FDA regulatory standing impact suppliers for EC-Naprosyn?
Featured answer: Not determinable from the provided context.
What to check in FDA records
- inspection history for listed manufacturing sites
- any Form 483 observations affecting manufacturing
- recall history
- The prompt provides no supplier/site list to audit.
What’s the commercial exposure if EC-Naprosyn shifts suppliers?
Featured answer: Not determinable from the provided context.
What drives switching risk
- NDAs/labeling changes
- contract manufacturing reassignments
- regulatory supplements for manufacturing site changes
- distribution contract renewals
- Without site-level supplier data, exposure can’t be quantified.
Key Takeaways
- Named suppliers for EC-Naprosyn cannot be identified from the information provided.
- A correct supplier answer requires the EC-Naprosyn FDA listing (labeler/manufacturer sites and NDCs) plus the Orange Book “listed drug” and, for generics, corresponding ANDA manufacturer/packager data.
- With those identifiers, supplier mapping can be done cleanly by strength and dosage form.
FAQs
- What data fields show the manufacturing supplier for a branded drug on FDA listings?
- How can I map EC-Naprosyn NDCs to manufacturer sites?
- What’s the difference between an FDA labeler and a contract manufacturer?
- How do Orange Book listed patents influence who can supply generic naproxen tablets?
- What records should be reviewed to assess manufacturing reliability for naproxen tablet suppliers?
References
No sources were cited because no FDA Orange Book labeler/manufacturer data, NDA/ANDA identifiers, or NDCs were provided in the prompt.
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