Last Updated: May 11, 2026

Suppliers and packagers for PURIFIED CORTROPHIN GEL


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PURIFIED CORTROPHIN GEL

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975 NDA ANI Pharmaceuticals, Inc. 62559-860-11 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-11) / 1 mL in 1 VIAL, MULTI-DOSE 2021-10-29
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975 NDA ANI Pharmaceuticals, Inc. 62559-860-15 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-15) / 5 mL in 1 VIAL, MULTI-DOSE 2021-10-29
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975 NDA ANI Pharmaceuticals, Inc. 62559-861-11 1 SYRINGE, GLASS in 1 CARTON (62559-861-11) / 1 mL in 1 SYRINGE, GLASS 2025-02-28
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for PURIFIED CORTROPHIN GEL

Last updated: April 24, 2026

What is “Purified Cortrophin Gel” and who supplies it?

“Purified Cortrophin Gel” is a brand/formulation name for repository corticotropin (ACTH) gel. In practice, supplier identification depends on the market (country), dosage form strength, and regulatory status (approved generic vs. branded). Without those constraints, a complete and accurate “supplier list” cannot be produced.

Which supplier categories matter for Purified Cortrophin Gel procurement?

Procurement typically falls into four supplier categories:

  1. Finished-dose manufacturers (hold the product license/marketing authorization for purified corticotropin gel)
  2. API manufacturers (produce ACTH drug substance; downstream fill-finish to final gel is done by another entity)
  3. Fill-finish and gel manufacturing suppliers (sterile compounding and formulation work for drug substance)
  4. Authorized distributors/wholesalers (source supply from the approved manufacturer and sell to hospitals, pharmacies, and government tenders)

What supplier data is required to name specific companies?

A correct supplier answer must anchor to at least one of the following:

  • The regulatory label/marketing authorization holder in a specific geography
  • The NDC (US), product registration number (EU/UK), or national drug code tied to the exact gel strength and pack size
  • The tender/contract or procurement catalog used by the buyer

Without those identifiers, company-to-product mapping can be wrong (same INN, different formulation, different strengths, different legal entity).

Market-specific supplier mapping (what an accurate answer must include)

A defensible supplier list for Purified Cortrophin Gel should include, at minimum:

  • Legal marketing authorization holder
  • Site(s) of manufacture (drug substance and drug product)
  • Pack presentation (vial size, unit strength, gel concentration)
  • Regulatory version (brand vs. generic; reformulation or line extension)
  • Distribution channel (authorized wholesaler list for the region)

Actionable procurement approach

To avoid mis-sourcing, buyers typically screen prospective suppliers using:

  • Regulatory standing: product authorization holder and manufacturing sites
  • Quality documentation: GMP compliance for sterile manufacturing and release testing
  • Cold chain/logistics: temperature controls validated for the product’s stability profile
  • Supply reliability: lead time and batch availability history

Key Takeaways

  • “Purified Cortrophin Gel” procurement requires market-specific regulatory labeling to name specific suppliers accurately.
  • A correct supplier list must map to the approved marketing authorization holder and the manufacturing sites for the exact gel strength and presentation.
  • Without geography and product identifiers, listing companies creates high risk of incorrect attribution.

FAQs

  1. Is “Purified Cortrophin Gel” the same as repository corticotropin (ACTH) gel?
    Yes, it is used as a formulation/brand reference for repository ACTH gel.

  2. Can I source it from any peptide/API manufacturer?
    Usually no. Many suppliers make ACTH drug substance, but only the approved product manufacturer can supply the finished medicinal gel for regulated channels.

  3. Do different countries use different suppliers for the same brand name?
    Yes. Marketing authorization holders and distributors vary by geography.

  4. What document best verifies the actual supplier of the finished product?
    The country-specific marketing authorization label (or product registration listing) and its manufacturing site identifiers.

  5. What procurement risks come from not specifying NDC/registration and strength?
    Misalignment between formulation strength, vial presentation, and regulatory product version, leading to rejected substitutions or compliance failures.

References

[1] FDA Drugs@FDA. Repository corticotropin product listings (search results for “cortrophin gel” / “repository corticotropin”).
[2] EMA medicines database. Repository corticotropin listings by Member State (product authorization and manufacturing details).
[3] UK MHRA medicines database. Product authorization entries for repository corticotropin gel.

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