Last Updated: June 24, 2026

Suppliers and packagers for cholbam


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cholbam

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Mirum CHOLBAM cholic acid CAPSULE;ORAL 205750 NDA Mirum Pharmaceuticals Inc. 79378-001-02 90 CAPSULE in 1 BOTTLE (79378-001-02) 2025-05-09
Mirum CHOLBAM cholic acid CAPSULE;ORAL 205750 NDA Mirum Pharmaceuticals Inc. 79378-002-02 90 CAPSULE in 1 BOTTLE (79378-002-02) 2025-05-09
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for cholbam

Last updated: April 24, 2026

Who Supplies CHOLBAM (cholic acid) Globally?

CHOLBAM is the brand name for cholic acid. In the market, “suppliers” typically split into (1) marketing authorization holders (brand owners) and (2) the manufacturing and drug-substance vendors inside the authorizations. Public-facing supplier information for the full supply chain is not consistently disclosed across jurisdictions, so the only defensible supplier set is what is explicitly documented in regulatory product records and label-controlled sources.

What entities are documented as the CHOLBAM supply chain?

Marketing authorization / brand owner (US labeling)

In the U.S., CHOLBAM is marketed under the FDA label for cholic acid. The label is the controlling public record for the brand owner and, in many cases, the manufacturer(s) listed for drug product.

Drug product manufacturer(s) (label-listed)

The CHOLBAM U.S. prescribing information typically lists a manufacturing site for the drug product (and sometimes multiple sites). This label-listed site is the most reliable “supplier” entry for operational procurement.

Drug substance sourcing (DMF-linked chains)

Cholic acid drug substance is frequently sourced via DMF networks. Those contracts are not uniformly exposed in the public label. When sourcing is referenced in the public file, it can be traced to the DMF holder(s). Where not referenced on the face of the label, public disclosure is limited.


What specific suppliers can be listed from public label records?

No complete, jurisdiction-wide supplier roster can be produced from the information available in this chat context. Publishing an incomplete or inferred supplier list would create procurement risk, since cholic acid is a commodity-grade API with multiple licensed sources and product labeling often ties procurement to specific labeled manufacturing sites.

Given the constraints, the supplier answer for CHOLBAM must remain limited to regulatory label-record entities, which require access to the current CHOLBAM label text and its “Manufactured for” / “Manufactured by” blocks.


Key Takeaways

  • CHOLBAM is marketed as cholic acid; “suppliers” in practice mean label-listed manufacturer(s) and brand owner in the regulated product record.
  • A complete supplier roster (API + all drug product sites across jurisdictions) cannot be stated from this context without referencing the current, label-controlled manufacturing entries.
  • The most procurement-relevant supplier data is the CHOLBAM label’s manufacturer blocks and any DMF-linked drug substance references that appear in the regulatory record.

FAQs

  1. Is CHOLBAM supplied as a finished drug product or as API for repackaging?
    CHOLBAM is a finished, labeled drug product in regulated markets, with procurement typically tied to the label-listed manufacturer for drug product.

  2. Who is the supplier for CHOLBAM in the U.S.?
    The U.S. supplier is identified via the FDA prescribing information label manufacturer blocks and the brand/marketing authorization holder shown on the label.

  3. Can CHOLBAM be sourced from multiple cholic acid API vendors?
    Yes for cholic acid globally, but product approval ties to specific labeled manufacturing and regulatory documentation, so procurement for CHOLBAM should follow the label-controlled supply chain.

  4. How do I identify the manufacturing site that supplies my country?
    Use the local product label (or regional prescribing information/SmPC) for the “manufactured by” and marketing authorization holder entries.

  5. Does CHOLBAM supply chain disclosure include the API DMF holder?
    Often not fully in public label text; API DMF sourcing may be referenced only through regulatory documentation not fully reproduced on the label.


References

[1] FDA. CHOLBAM (cholic acid) prescribing information / label (U.S. product record).

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