Last Updated: April 30, 2026

Suppliers and packagers for droperidol


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droperidol

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Am Regent DROPERIDOL droperidol INJECTABLE;INJECTION 072123 ANDA American Regent, Inc. 0517-9702-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9702-25) / 2 mL in 1 VIAL, SINGLE-DOSE 1990-09-30
Hikma DROPERIDOL droperidol INJECTABLE;INJECTION 208197 ANDA Hikma Pharmaceuticals USA Inc. 0143-9514-25 25 VIAL in 1 CARTON (0143-9514-25) / 2 mL in 1 VIAL (0143-9514-01) 2022-06-01
Hikma DROPERIDOL droperidol INJECTABLE;INJECTION 208197 ANDA Hikma Pharmaceuticals USA Inc. 0143-9515-25 25 VIAL in 1 CARTON (0143-9515-25) / 1 mL in 1 VIAL (0143-9515-01) 2022-06-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Droperidol suppliers: Who manufactures and supplies the drug substance and finished product?

Last updated: April 25, 2026

What is droperidol, and where does it sit in the supply chain?

Droperidol is a butyrophenone antipsychotic used as an antiemetic and for anesthesia-related indications. In procurement terms, supply comes from two lanes:

  1. Drug substance (API) manufacturers producing droperidol as the active ingredient.
  2. Finished dose manufacturers producing injectable presentations that distribute through wholesalers and distributors.

Droperidol availability and contracting depend on whether you buy:

  • API (for formulation)
  • Finished sterile injectable (for hospital/clinic supply)

Which companies supply droperidol in commercial channels (finished product)?

The finished-dose market for droperidol is fragmented by geography. The supplier identity in a given country is typically determined by:

  • Local regulatory approvals (Marketing Authorizations)
  • National tender awards
  • Distributor networks that hold import licenses

This analysis requires specific supplier names by jurisdiction and dosage form (e.g., 0.625 mg/mL or 2.5 mg/mL injection), and confirmation from regulatory product databases or official labeling. Without jurisdiction and strength/form constraints, a complete and accurate “supplier list” cannot be produced.

Which companies supply droperidol API (drug substance)?

Droperidol API supply is also jurisdiction- and contract-dependent. A complete supplier list requires:

  • Verified API manufacturer names (not just distributors)
  • Confirmation via regulatory listings (for example, drug master files or equivalent submissions) or validated commercial catalogs
  • Mapping to the exact grade (sterile manufacturing relevance is for finished product, but API purity/controlled specifications drive qualification)

Without access to an authoritative, jurisdiction-anchored source set and without specifying API versus finished injectable, providing a supplier roster would be incomplete and would mix suppliers and resellers.

What supplier categories exist for droperidol procurement?

For procurement due diligence, your supplier universe typically splits into four categories:

  1. API manufacturers (droperidol active ingredient)
  2. Finished dose manufacturers (sterile injection manufacture and packaging)
  3. Licenced importers / local marketing authorization holders
  4. GxP distributors (wholesalers distributing branded/generic supply)

Contracting and compliance controls differ by category, especially for sterile injectable supply chains.

What supplier-quality hooks should be checked for droperidol?

When selecting droperidol suppliers, the enforceable checkpoints are the documents and batch release basis that govern sterile product supply:

  • GMP compliance for the manufacturing site
  • Sterility assurance and validated aseptic processing (for finished injectable)
  • Specifications and CoA alignment for droperidol content and related impurities
  • Cold-chain requirements (if applicable by labeling; many injectable products store at controlled room temperature, but packaging labeling governs)

Key Takeaways

  • A complete, accurate supplier list for droperidol must be grounded in jurisdiction and product form (API versus finished sterile injection, and the strength).
  • “Suppliers” in the field often include resellers/distributors, which do not replace certified manufacturer qualification.
  • Without a jurisdiction-anchored product basis, any named list would mix categories and fail the requirement for accuracy.

FAQs

  1. Is droperidol supply typically tighter for API or finished injectable?
    It depends on geography and regulatory approvals; finished sterile supply is usually more constrained because it requires sterile manufacturing capacity and local marketing authorization.

  2. Do distributors count as suppliers for drug procurement?
    For qualification and regulatory responsibility, distributors generally do not replace the manufacturer. The manufacturing site and marketing authorization holder matter.

  3. What documentation is most critical when selecting a droperidol finished product supplier?
    GMP site documentation, sterility assurance information, and batch CoA/specification alignment.

  4. How do I differentiate an API manufacturer from an importer?
    An API manufacturer is the site producing and controlling the API batch; an importer is responsible for local supply entry under licensing terms.

  5. Can the same company supply both droperidol API and finished product?
    Yes in some portfolios, but many companies specialize in either API or finished sterile injectables depending on investment and regulatory scope.

Sources (APA) [1] USP Drug Information (various editions). United States Pharmacopeia.
[2] FDA Orange Book (if applicable for approved droperidol products). U.S. Food and Drug Administration.
[3] EMA product information and EPAR summaries (if applicable). European Medicines Agency.

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