Last Updated: June 25, 2026

Suppliers and packagers for neoprofen


✉ Email this page to a colleague

« Back to Dashboard


neoprofen

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Recordati Rare NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903 NDA Recordati Rare Diseases Inc. 55292-122-52 3 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIAL 2006-04-13
Recordati Rare NEOPROFEN ibuprofen lysine INJECTABLE;INTRAVENOUS 021903 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-490-36 3 VIAL in 1 CARTON (66993-490-36) / 2 mL in 1 VIAL 2016-04-14
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for neoprofen

Last updated: May 29, 2026

Suppliers for Neoprofen (neoprofen) Drug: Who Manufactures, Fills, and Controls the Supply Chain?

Neoprofen is the U.S.-market brand name used for the active ingredient neprofen. No complete, source-backed supplier roster can be produced from the information available here; supplier listings must be verified against FDA drug master files (DMFs), Orange Book listings, label/manufacturer build-outs, wholesaler/distributor authorizations, and GMP inspection records.


Who supplies neoprofen API and how is the active ingredient sourced?

A reliable supplier answer requires identifying the API manufacturer(s) used in approved finished-product labeling and, where applicable, DMF holders for the corresponding drug substance. Without source-confirmed Orange Book or labeling data for Neoprofen (neprofen), any supplier list would be speculative.

What counts as a “supplier” for neoprofen in pharma supply-chain terms

  • API manufacturer (drug substance)
  • Finished-dose manufacturer (drug product)
  • Primary packager (blistering, bottling, labeling)
  • Secondary packager/distributor (cartoning, wholesaling)
  • Contract manufacturing organization (CMO) and contract packaging organization (CPO)
  • DMF holders (process and synthesis disclosure)

What finished-product manufacturers supply neoprofen tablets, capsules, or suspensions?

Finished-product suppliers are identified in FDA labeling (NDC labeler/manufacturer details) and Orange Book “Applicant/Holder” records tied to specific strengths, dosage forms, and NDCs. No verified NDC-to-manufacturer mapping for Neoprofen (neprofen) is available here.

Which documents normally identify neoprofen drug product manufacturers

  • FDA label “Manufactured for” and “Distributed by” sections
  • DailyMed label “Manufactured by” and “Packaged by”
  • Orange Book listings by NDC and applicant
  • NDC directory and reconciliation against labeler codes

Which companies hold DMFs for neoprofen bulk drug substance?

DMF holders for neprofen must be verified via FDA DMF database searches by:

  • DMF holder name
  • DMF number(s)
  • drug substance name spelling and synonym variants
  • cross-link to approved drug products

No DMF evidence is available in the provided context.


What is the Orange Book status of neoprofen and how does it identify suppliers?

Orange Book status connects:

  • active ingredient(s)
  • dosage forms/strengths
  • listed patents and exclusivity
  • NDA/ANDA holders and applicants

Without a confirmed Orange Book entry for “Neoprofen (neprofen)” in the current prompt context, supplier attribution from Orange Book cannot be completed without making unsupported claims.


Do generic manufacturers supply neoprofen, and what are the market entry pathways?

Generic suppliers must be tied to:

  • ANDA approvals for neprofen dosage forms and strengths
  • NDC-specific labeler/manufacturer statements
  • whether entry occurred via Paragraph IV or non-Paragraph IV pathways
  • timing from approval/launch data

No ANDA/market entry record for Neoprofen (neprofen) is available here.


Which packaging and logistics suppliers distribute neoprofen finished goods?

Packaging and logistics partners show up in:

  • label “Packaged by” lines
  • NDC labeler/distributor identifiers
  • importer-of-record details for international supply

No labeling or NDC distribution detail is available here.


How can procurement teams qualify neoprofen suppliers for GMP and regulatory compliance?

A procurement-grade qualification package for neoprofen typically uses:

  • GMP status (FDA inspection outcomes for drug substance and drug product sites)
  • CoA and batch genealogy support
  • DMF linkage and change-control history
  • stability data and validated manufacturing controls
  • regulatory dossier consistency across NDCs/strengths

A supplier-by-supplier qualification requires site-level evidence that is not present in the current prompt.


Key Takeaways

  • A verified supplier map for Neoprofen (neprofen) cannot be produced from the information provided.
  • Any definitive list of API makers, CMO/CPO partners, and distributors must be built from FDA labeling, Orange Book/DMF records, and NDC-to-manufacturer mappings for each dosage form and strength.

FAQs

Who are the API manufacturers of neprofen?

Not determinable from the provided information; API supplier identification requires FDA label/DMF-backed sourcing.

Which companies manufacture neoprofen finished tablets or capsules?

Not determinable from the provided information; finished-product suppliers require NDC-specific label evidence.

Are there multiple neoprofen suppliers across different strengths or NDCs?

Not determinable from the provided information; NDC-by-NDC mapping is required.

Do neoprofen generics exist and which companies make them?

Not determinable from the provided information; requires ANDA approval and launch records.

How do I verify neoprofen supplier claims for GMP compliance?

Verification requires FDA GMP inspection outcomes, DMF linkages, and batch documentation tied to specific manufacturing sites.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.