Last Updated: June 24, 2026

Suppliers and packagers for OZOBAX DS


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OZOBAX DS

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Metacel Pharms Llc OZOBAX DS baclofen SOLUTION;ORAL 208193 NDA AUTHORIZED GENERIC Atlantic Biologicals Corp. 17856-0620-1 72 CUP, UNIT-DOSE in 1 CASE (17856-0620-1) / 2.5 mL in 1 CUP, UNIT-DOSE 2023-10-12
Metacel Pharms Llc OZOBAX DS baclofen SOLUTION;ORAL 208193 NDA AUTHORIZED GENERIC Atlantic Biologicals Corp. 17856-0620-2 72 CUP, UNIT-DOSE in 1 CASE (17856-0620-2) / 5 mL in 1 CUP, UNIT-DOSE 2023-10-12
Metacel Pharms Llc OZOBAX DS baclofen SOLUTION;ORAL 208193 NDA AUTHORIZED GENERIC TRUPHARMA, LLC 52817-620-08 237 mL in 1 BOTTLE (52817-620-08) 2023-10-12
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for OZOBAX DS

Last updated: June 1, 2026

OZOBAX DS Suppliers: What Companies Manufacture and Supply Baclofen Oral Suspension (DS) and Who Controls Procurement

OZOBAX DS is an oral suspension formulation of baclofen used for patients who cannot take tablets. Supplier identification depends on who holds the commercial label for the U.S. product (NDC/labeler) and who manufactures on contract (CDMO) versus who provides active ingredient (API) and critical excipients. No complete supplier map can be produced from the information provided.

Which companies supply OZOBAX DS in the US?

Featured-snippet answer: Not enough information to reliably identify the U.S. commercial labeler (NDC labeler) and the contract manufacturing organizations (CMOs) for OZOBAX DS.

How to identify the OZOBAX DS “supplier” from regulatory documentation

In practice, “supplier” can mean:

  • NDC labeler (the marketing authorization holder for the U.S. listing)
  • Manufacturer(s) of record for drug product (facility and company name)
  • API suppliers for baclofen
  • Excipients suppliers for oral suspension components (e.g., suspending agents, sweeteners, buffers, preservatives)

Without the NDC/labeler record or FDA listing-level data for OZOBAX DS, any company names would be speculative.

What is the Orange Book status of OZOBAX DS and does that affect supplier selection?

Featured-snippet answer: Not enough information to determine Orange Book listings for OZOBAX DS.

Does baclofen oral suspension have listed patents?

Even when the active ingredient is off-patent, reformulations (specific suspension composition, particle size/dispersibility targets, stability, preservatives) can lead to separate patent estates that affect which suppliers can legally manufacture and how contracts are structured. No patent or Orange Book record is provided.

Who manufactures OZOBAX DS oral suspension (CDMO) and where is it made?

Featured-snippet answer: Not enough information to identify specific CDMOs or manufacturing sites for OZOBAX DS.

Common manufacturing-supply patterns to check

When supplier names are determinable, they usually appear as:

  • “Manufacturer” and “Labeler” in FDA product listing records
  • Site-specific drug product manufacturing in batch/inspection records
  • Label statements indicating “Manufactured for” the labeler

No label/inspection entries were provided here.

Which baclofen API suppliers feed OZOBAX DS?

Featured-snippet answer: Not enough information to identify baclofen API suppliers tied to OZOBAX DS.

Why API supplier attribution matters

API origin can be contractually controlled through:

  • supply agreements (single-source or qualified-multi-source)
  • quality agreements (DMF references and change-control constraints)
  • regulatory commitments (API supplier changes can trigger reporting and validation steps)

No DMF or API reference details for OZOBAX DS were provided.

What suppliers provide key excipients for OZOBAX DS suspensions?

Featured-snippet answer: Not enough information to name excipient suppliers used in OZOBAX DS.

Excipients typically relevant to oral suspension sourcing

Oral suspension supply chains often rely on distinct vendors for:

  • suspending agents (viscosity/stability control)
  • preservatives and antioxidants (microbial stability)
  • buffers and pH adjusters (taste and chemical stability)
  • sweeteners/flavor systems (patient acceptability) No composition-level sourcing data was provided.

How does distribution affect OZOBAX DS suppliers (wholesale vs direct)?

Featured-snippet answer: Not enough information to map wholesalers, GPO channels, or direct distribution partners for OZOBAX DS.

Where “supplier” changes meaning

Procurement teams often see:

  • primary distributor (wholesale)
  • secondary distributor (regional)
  • institution-specific GPO bid holder Without NDC distribution channel data, supplier mapping is incomplete.

Key Takeaways

  • “Suppliers for OZOBAX DS” cannot be stated with required specificity without OZOBAX DS FDA listing identifiers (NDC/labeler) and manufacturing/APIs/excipient sourcing records.
  • Any list of company names would be non-actionable and risk being incorrect.

FAQs

  1. What does “manufacturer” mean on OZOBAX DS labeling?
  2. How do I determine the NDC labeler for OZOBAX DS?
  3. Can baclofen oral suspension be made by multiple CDMOs for the same NDC?
  4. Where do excipient suppliers appear for U.S. oral suspensions?
  5. Does OZOBAX DS use a DMF-referenced baclofen API with named suppliers?

References

No sources were provided or cited in the prompt.

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