Last Updated: May 10, 2026

Suppliers and packagers for generic pharmaceutical drug: chlorpromazine hydrochloride


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chlorpromazine hydrochloride

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Genus CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride CONCENTRATE;ORAL 214542 ANDA Sandoz, Inc. 0781-4027-53 120 mL in 1 BOTTLE, PLASTIC (0781-4027-53) 2023-03-31
Genus CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride CONCENTRATE;ORAL 214542 ANDA Sandoz, Inc. 0781-4028-22 240 mL in 1 BOTTLE, PLASTIC (0781-4028-22) 2023-03-31
Rubicon CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride CONCENTRATE;ORAL 216678 ANDA Advagen Pharma Ltd 72888-457-01 120 mL in 1 BOTTLE (72888-457-01) 2025-10-10
Rubicon CHLORPROMAZINE HYDROCHLORIDE chlorpromazine hydrochloride CONCENTRATE;ORAL 216678 ANDA Advagen Pharma Ltd 72888-458-01 240 mL in 1 BOTTLE (72888-458-01) 2025-10-10
Saptalis Pharms SONAZINE chlorpromazine hydrochloride CONCENTRATE;ORAL 080983 ANDA Saptalis Pharmaceuticals, LLC. 71656-101-08 240 mL in 1 BOTTLE, PLASTIC (71656-101-08) 2026-03-04
Saptalis Pharms SONAZINE chlorpromazine hydrochloride CONCENTRATE;ORAL 080983 ANDA Saptalis Pharmaceuticals, LLC. 71656-102-04 120 mL in 1 BOTTLE, PLASTIC (71656-102-04) 2026-03-04
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Chlorpromazine Hydrochloride

Last updated: April 25, 2026

Who supplies chlorpromazine hydrochloride (API) globally?

Chlorpromazine hydrochloride is a legacy, off-patent active pharmaceutical ingredient (API) with broad manufacturing coverage across India, China, Europe, and the US. The key business distinction for procurement is whether a supplier provides API, finished dosage forms (tablets/injection), or both.

Which companies are active suppliers of chlorpromazine hydrochloride API or finished drug products?

Below are supplier categories that are directly relevant for sourcing chlorpromazine hydrochloride. (Names reflect companies that are regularly listed as manufacturers and/or distributors for this molecule in industry catalogs and regulatory-facing supply chains.)

API manufacturers and distributors (chlorpromazine hydrochloride)

  • Mylan / Viatris (historical and ongoing legacy supply through channel partners)
  • Wuxi AppTec / WuXi PharmaTech (contract manufacturing capability for small-molecule APIs and intermediates; chlorpromazine is typically supported via legacy/off-patent workflows depending on dossier scope)
  • Hangzhou HuaDong / related CN API manufacturers (legacy antipsychotic API capacity; chlorpromazine is widely produced in China for generic supply chains)
  • Lupin (via generic supply chain partners and regional distribution; chlorpromazine is commonly stocked in hospital channels in multiple markets)
  • Sun Pharmaceutical Industries (generic legacy products distributed widely; chlorpromazine sourcing is commonly routed through local branded/generic channels)
  • Teva (generic legacy supply chain; country-dependent distribution)
  • Aurobindo Pharma (generic manufacturing and distribution footprint for legacy neuroleptics, market-dependent)
  • Cipla (market-dependent finished-product supply and legacy channel availability)

Finished dosage form manufacturers (tablets and injection)

Chlorpromazine is most often sourced through finished drug product supply relationships for hospitals (formulary-based procurement) rather than direct API purchase. Finished product supply is split by dosage form and market authorization, including:

  • Chlorpromazine tablets (oral)
  • Chlorpromazine injection (IM/IV, formulation dependent by country)

Procurement implication: Most buyers in healthcare systems purchase the finished product from authorized manufacturers or wholesalers, not the API, because of variability in excipients, packaging, and country-specific GMP/dossier requirements.

Which sourcing routes typically work for chlorpromazine hydrochloride in practice?

Route 1: Buy finished product through authorized wholesalers

  • Best fit for hospitals, tenders, and distributors
  • Lower regulatory friction than API sourcing
  • Faster availability for routine stock

Route 2: Buy API through GMP-qualified suppliers

  • Best fit for generic manufacturers, contract manufacturers, and repackagers
  • Requires compatibility with the buyer’s finished-product dossier (process, quality attributes, impurity profile)

Route 3: Use contract manufacturing (CMO/CDMO) for formulation and packaging

  • Best fit when internal formulation capability is absent
  • Typically driven by local market requirements and existing dossier strategy

Market-specific supplier behavior

Chlorpromazine hydrochloride availability varies by geography due to:

  • local regulatory approvals (finished product marketing authorizations)
  • hospital procurement cycles and tender schedules
  • country-specific availability of injection formulations (often the scarcest SKU)

In practice, the supplier landscape is stable for tablets but can be more volatile for injection in some markets because injection supply ties to sterile manufacturing capacity and batch release controls.

Supplier selection criteria (what buyers should enforce)

For chlorpromazine hydrochloride sourcing, commercial qualification is usually driven by the same checklist across API and finished product procurement:

For API suppliers

  • GMP status (certificate of suitability or local GMP compliance, where applicable)
  • DMF/EDMF alignment with the buyer’s regulatory pathway (if the buyer depends on an approved/registered dossier)
  • Impurity profile control consistent with established specifications for chlorpromazine hydrochloride
  • Supply reliability (batching cadence and lead time stability)

For finished product suppliers

  • Country authorization for the exact dosage form and strength
  • Sterility assurance for injection products (where relevant)
  • Packaging configuration aligned to tender and handling requirements
  • Batch traceability and COA cadence (COA per lot is a procurement baseline)

Where do chlorpromazine hydrochloride suppliers cluster?

Supplier clustering is consistent with small-molecule generic manufacturing footprints:

  • India and China account for most global API and generic finished-product capacity for off-patent molecules, including chlorpromazine.
  • Europe and the US tend to supply through finished product channels and authorized generic portfolios, often with API sourced from global qualified manufacturers.

Key takeaways

  • Chlorpromazine hydrochloride sourcing is dominated by generic, off-patent supply chains with many candidate manufacturers and distributors.
  • Buyers usually succeed faster by sourcing the finished product (especially for hospital procurement), while manufacturers who need API typically qualify multiple GMP-capable sources.
  • Supplier choice should be driven by market authorization (finished product) or GMP and dossier/impurity alignment (API), not catalog availability alone.

FAQs

1) Is chlorpromazine hydrochloride available as both API and finished product?

Yes. It is supplied as an API for generic manufacturing and as finished tablets and injection formulations for clinical use.

2) What is the primary buying route for hospitals?

Hospitals generally procure the finished drug product through authorized wholesalers due to dosing, excipients, packaging, and regulatory release requirements.

3) What matters most for API qualification?

GMP compliance, impurity profile consistency, and alignment with the buyer’s regulatory dossier needs.

4) Is chlorpromazine injection typically harder to source than tablets?

In many markets, injection can be more constrained due to sterile manufacturing capacity and batch release demands, even when tablets remain widely stocked.

5) Which regions dominate chlorpromazine supply?

Global supply clusters around India and China for API and generic finished products, with Europe and the US contributing through authorized finished-product portfolios and local distribution.


References

[1] EMA. European public assessment reports and product dossiers (search platform for chlorpromazine-containing medicines). https://www.ema.europa.eu/en
[2] FDA. Drug labels and reference listed drug information (search for chlorpromazine hydrochloride products). https://www.accessdata.fda.gov/scripts/cder/daf/
[3] WHO. WHO Model Lists and essential medicines references where applicable for chlorpromazine availability and use. https://www.who.int/publications/series/model-list-of-essential-medicines

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