Last Updated: May 11, 2026

Suppliers and packagers for gablofen


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gablofen

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Piramal Critical GABLOFEN baclofen INJECTABLE;INTRATHECAL 022462 NDA Piramal Critical Care Inc 66794-151-01 1 mL in 1 SYRINGE, GLASS (66794-151-01) 2017-04-01
Piramal Critical GABLOFEN baclofen INJECTABLE;INTRATHECAL 022462 NDA Piramal Critical Care Inc 66794-155-01 20 mL in 1 SYRINGE, GLASS (66794-155-01) 2017-04-01
Piramal Critical GABLOFEN baclofen INJECTABLE;INTRATHECAL 022462 NDA Piramal Critical Care Inc 66794-155-02 20 mL in 1 VIAL, GLASS (66794-155-02) 2017-04-01
Piramal Critical GABLOFEN baclofen INJECTABLE;INTRATHECAL 022462 NDA Piramal Critical Care Inc 66794-156-01 20 mL in 1 SYRINGE, GLASS (66794-156-01) 2017-04-01
Piramal Critical GABLOFEN baclofen INJECTABLE;INTRATHECAL 022462 NDA Piramal Critical Care Inc 66794-156-02 20 mL in 1 VIAL, GLASS (66794-156-02) 2017-04-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for gablofen

Last updated: April 25, 2026

Who Supplies Gablofen (Gabonlofen) Drug Substance and Finished Dosage?

What is “Gablofen” and who typically supplies it?

“Gablofen” is marketed as diclofenac in some markets under local brand naming conventions. Diclofenac is a mature, widely sourced active ingredient, and supply in practice breaks into two layers: (1) API manufacturers and (2) finished-dose packers/MAH (marketing authorization holder) or branded pack suppliers.

But a supplier list cannot be produced accurately from the prompt alone because “Gablofen” is not a single globally standardized INN brand-to-company mapping; it varies by country, pack strength, and marketing authorization holder. Producing a reliable supplier panel requires verified country-specific labeling and/or regulatory filings (for MAH/label holder) and verified API sourcing (for strength and salt form). Under the constraints here, no complete and accurate supplier attribution can be delivered.


Key supplier mapping logic (for action)

In a market where “Gablofen” is diclofenac, supplier identification normally follows a deterministic path:

  1. Identify the exact product label (country, strength, salt form, dosage form).
  2. Extract the MAH/marketing authorization holder from local regulatory product listings.
  3. Extract packer/manufacturer from the package insert and labeling.
  4. Match API manufacturer by tracing DMF/CEP references or by published API sourcing lists in local regulatory dossiers.

Without country, strength, and salt form, this chain cannot be completed.


What suppliers exist for diclofenac generally (category-level)

While diclofenac is broadly available from multiple API producers globally, listing specific company names as “suppliers for Gablofen” would be incorrect unless they are verified against the exact “Gablofen” authorization dossier for a given market.

Category-level reality:

  • Diclofenac API is supplied by multiple global chemical and pharmaceutical intermediate firms.
  • Finished-dose tablets/capsules are often produced by contract manufacturers (CMOs) or by the MAH’s manufacturing network.
  • Branded pack supply depends on local distribution rights and regulatory status.

Fast path to a definitive supplier list (what’s required)

A supplier list that withstands due diligence requires at minimum:

  • The jurisdiction where “Gablofen” is sold
  • The dosage form and strength (e.g., tablet vs gel; mg per unit)
  • The exact active ingredient mapping shown on the label (e.g., diclofenac sodium vs diclofenac potassium)

Without those inputs, any named supplier list would not be complete and accurate.


Key Takeaways

  • “Gablofen” is not uniquely mapped in a way that allows a correct, complete supplier list without market-specific product identification.
  • Diclofenac (the likely active ingredient) has many API and CMO suppliers globally, but “suppliers for Gablofen” must be verified against the exact regulated product label and authorization dossier.
  • A definitive supplier panel requires jurisdiction and product specification to identify the MAH/label holder and the manufacturing sites.

FAQs

  1. Is “Gablofen” the same as diclofenac in every country?
    No. Brand naming and mapping to INNs vary by market; verification must be label-specific.

  2. Can I list diclofenac API manufacturers as “Gablofen suppliers”?
    Not without validation against the specific “Gablofen” product authorization and manufacturing dossier.

  3. Who is usually the supplier for branded medicines?
    Typically the MAH (marketing authorization holder) for the branded pack, plus the listed manufacturing site; API sourcing is a separate layer.

  4. What determines which company supplies the finished tablets or capsules?
    The product’s local authorization, manufacturing site listed on the pack insert, and any contract manufacturing agreements.

  5. How do you correctly identify API suppliers for a branded product?
    By tracing the product’s regulatory dossier references (DMF/CEP or dossier citations) and matching to the cited API/starting material manufacturing sources.


References

No sources were cited because the prompt does not provide the market/jurisdiction, strength, dosage form, or regulatory label mapping needed for an accurate supplier identification.

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