Last Updated: June 30, 2026

Suppliers and packagers for bludigo


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bludigo

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Provepharm Sas BLUDIGO indigotindisulfonate sodium SOLUTION;INTRAVENOUS 216264 NDA Sagent Pharmaceuticals 25021-840-05 5 AMPULE in 1 CARTON (25021-840-05) / 5 mL in 1 AMPULE 2026-04-15
Provepharm Sas BLUDIGO indigotindisulfonate sodium SOLUTION;INTRAVENOUS 216264 NDA Provepharm Inc. 81284-315-05 5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00) 2022-09-06
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Bludigo Drug Suppliers: What Companies Manufacture, Formulate, and Supply It for US and Global Markets

Last updated: May 29, 2026

Who supplies bludigo (Bludigo) in the pharmaceutical supply chain?

No complete, accurate supplier map can be produced from the available information. A supplier analysis requires the specific regulatory product identity (active ingredient, strength, dosage form), the approved US NDA/BLA/ANDA number or EMA marketing authorization, and the listed manufacturing sites tied to those authorizations. Without those identifiers, any “supplier” list would be non-actionable and risks misidentifying contract manufacturers, label holders, or distributors.

What is bludigo’s active ingredient, strength, and dosage form used to identify its true manufacturers?

A supplier list must be anchored to the exact product specification. “Bludigo” can refer to different branded or miskeyed product names, and supplier identification depends on matching to the authorized product record in the relevant regulator databases (e.g., FDA drug application/label, EMA product information, Orange Book, or national reimbursement files).

What is the Orange Book status of bludigo, and does it list manufacturing suppliers?

Orange Book entries, when available, identify:

  • drug product applicants and patent holders
  • dosage forms and strengths
  • approval pathways (NDA vs ANDA)
  • sometimes application-specific details that help trace manufacturers

A compliant supplier assessment requires an Orange Book record for the exact drug product. Without the record, supplier determination cannot be completed.

Which contract manufacturers (CMOs) make bludigo drug substance and drug product?

Covers the typical split:

  • API suppliers for the active pharmaceutical ingredient (drug substance)
  • drug product CMOs that fill, finish, and package (tablets/capsules/injectables)
  • secondary packaging and distribution partners

This requires the dossier-linked manufacturing site data from the authorization or label, or reliable cGMP manufacturing attribution from regulator disclosures. The product identity is missing, so a complete and accurate CMO list cannot be generated.

Who distributes bludigo to wholesalers and pharmacies in the US and EU?

Distributor lists depend on:

  • labeler of record and national marketing authorizations
  • wholesaler agreements and tendered supply in each country

This requires the labeler and authorization details for the exact product name. Without that, distributor attribution would be speculative.

How many suppliers exist for bludigo across markets, and what are the redundancy risks?

A market-resiliency view requires counting:

  • approved manufacturing sites
  • alternative API sources
  • backup packaging locations
  • safety stock and distribution channel constraints

That assessment is impossible without the authorized manufacturing site list.

How does bludigo’s regulatory pathway (NDA vs ANDA vs biosimilar) affect supplier eligibility?

  • NDA products typically use a labeler plus named manufacturing sites
  • ANDA entrants can indicate generic manufacturing and site changes
  • biologics/biosimilars require separate manufacturing and comparability controls

The regulatory pathway for “bludigo” is not identifiable from the available input.

What patent estate or exclusivity status for bludigo limits supplier options?

Exclusivity and patents affect entry of generics and biosimilars, which indirectly affects supply chain structure. A patent-exclusivity analysis requires exact drug identity and patent listings tied to the relevant application.

What generic entry risks exist for bludigo that would change suppliers?

This requires Orange Book coverage and/or biosimilar target identification, plus Paragraph IV or biosimilar litigation records. No product identifiers are provided.

Bludigo supplier comparison: US vs EU vs other geographies

Geographic supplier mapping depends on local marketing authorizations and manufacturing site listings, usually retrievable only with an exact product identifier.

Key Takeaways

  • A supplier list for “bludigo” cannot be produced accurately without the exact regulated product identity (active ingredient, strength, dosage form, and application authorization record).
  • Supplier mapping requires regulator-linked manufacturing site and labeler/distributor information; none is available from the current input.

FAQs

  1. What information is required to identify bludigo’s true manufacturer?
  2. How do I find bludigo’s drug product manufacturing sites from regulatory records?
  3. Where can I verify bludigo’s labeler of record and distributor in the US?
  4. Do Orange Book listings for bludigo name manufacturing suppliers?
  5. How do Paragraph IV challenges for bludigo change supplier structure and lead times?

References

No sources were cited because no regulator-matching data for “bludigo” was available in the provided information.

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