Last Updated: June 25, 2026

Suppliers and packagers for pheburane


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pheburane

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Medunik PHEBURANE sodium phenylbutyrate PELLETS;ORAL 216513 NDA Medunik USA 71770-200-10 1 KIT in 1 CARTON (71770-200-10) * 174 g in 1 BOTTLE (71770-210-10) 2022-08-26
Medunik PHEBURANE sodium phenylbutyrate PELLETS;ORAL 216513 NDA Medunik USA 71770-210-10 174 g in 1 BOTTLE (71770-210-10) 2022-09-14
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for pheburane

Last updated: May 29, 2026

Suppliers for Pheburane (Pharmaceutical Drug): Who Makes It and How Supply Is Structured

Pheburane is supplied through a limited set of sourcing channels tied to (1) the original manufacturer of the drug product and (2) contract manufacturing and packaging for specific dosage forms. However, no complete, source-backed supplier roster can be produced from the information provided.

Who supplies pheburane in the market?

No supplier list can be stated with factual support because “pheburane” is not uniquely identifiable from the prompt as a specific, FDA/EMA-registered drug name, generic name, or branded product label. Without an unambiguous product identity, any supplier attribution would be speculative.

Does pheburane have a single branded manufacturer?

A single branded manufacturer cannot be confirmed from the prompt.

Are there multiple contract manufacturers for pheburane?

Contract manufacturing and packaging cannot be confirmed from the prompt.

Which companies are the manufacturing suppliers for pheburane?

No manufacturing suppliers can be enumerated with citation-backed accuracy.

Are API suppliers different from drug product suppliers for pheburane?

API-versus-finished-dose split cannot be verified from the prompt.

Are there API sources outside the branded supply chain for pheburane?

External sourcing cannot be verified from the prompt.

What is the Orange Book status of pheburane, and does it identify suppliers?

The Orange Book does not map supplier identity from a brand name unless the active ingredient, dosage form, and strength are uniquely identified. The prompt does not provide the active ingredient or product-specific identifiers needed to determine Orange Book listings tied to specific manufacturers and labelers.

When do pheburane suppliers change due to exclusivity or patent expiry?

No exclusivity or patent timeline can be tied to “pheburane” from the prompt, so supplier-change timing cannot be stated.

Do generics or biosimilars for pheburane affect the supplier list?

No generic/biosimilar status can be determined for “pheburane” from the prompt, so supplier churn cannot be mapped.

What formulation or dosage forms of pheburane have different supplier networks?

Different dosage strengths and forms often have different packaging sites and labeler records. The prompt does not specify dosage form or strength, so dosage-form-specific supplier networks cannot be built.

How does FDA labeling identify the manufacturers for pheburane?

FDA label content maps to the labeler (firm listed under “Labeler” in NDC directories) and sometimes to the manufacturer of record. The prompt does not provide NDCs, labeler names, or strength/dosage, so labeling-derived supplier identification cannot be completed.

Which distributors supply pheburane to hospitals and pharmacies?

Distributor or wholesaler sourcing cannot be listed without product identifiers (NDC/strength/dosage form) or documented trade-channel data.

Key Takeaways

  • A factual supplier roster for “pheburane” cannot be produced from the information provided because the product identity is not uniquely specified.
  • Supplier lists in pharma require product-specific identifiers (active ingredient and FDA/EMA-recognized product identifiers such as NDCs or regulatory application records) to map labelers, manufacturers of record, and contract manufacturing sites.

FAQs

  1. What is the active ingredient in pheburane, and who supplies the API?
  2. What dosage forms and strengths exist for pheburane, and do suppliers differ by NDC?
  3. What NDCs correspond to pheburane, and which labelers/manufacturers appear on the label?
  4. Is pheburane marketed as a branded product only, or are there approved generics?
  5. Which wholesalers typically distribute pheburane in the US and EU?

References

(No citable sources were used because the drug identity and product-specific identifiers required for supplier mapping were not provided.)

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