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Suppliers and packagers for generic pharmaceutical drug: ZIPRASIDONE HYDROCHLORIDE
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ZIPRASIDONE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825 | NDA | ROERIG | 0049-0056-60 | 60 CAPSULE in 1 BOTTLE (0049-0056-60) | 2019-08-01 |
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825 | NDA | ROERIG | 0049-0058-60 | 60 CAPSULE in 1 BOTTLE (0049-0058-60) | 2019-08-01 |
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825 | NDA | ROERIG | 0049-0352-60 | 60 CAPSULE in 1 BOTTLE (0049-0352-60) | 2021-11-08 |
| Viatris | GEODON | ziprasidone hydrochloride | CAPSULE;ORAL | 020825 | NDA | ROERIG | 0049-0354-60 | 60 CAPSULE in 1 BOTTLE (0049-0354-60) | 2023-07-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Who Supplies Ziprasidone Hydrochloride? A Procurement Map by Drug-Substance and Market Channel
Ziprasidone hydrochloride is an API and drug-substance commodity used to manufacture antipsychotic products. Supply is concentrated among multipurpose API manufacturers plus specialty generics and branded supply chains. The sourcing landscape typically splits into four channels: (1) API manufacture and global distribution, (2) finished-dose contract manufacturing, (3) generic product supply, and (4) specialty distributors carrying international product and API.
Which companies manufacture ziprasidone hydrochloride API?
The most reliable “supplier list” for ziprasidone hydrochloride comes from regulatory and commercial supply-chain records (FDA lists for finished products and inspections, ECHA/REACH substance registrations, and global tendered API supply). Under those systems, ziprasidone hydrochloride is sourced by companies that already operate in the antipsychotic API segment and submit DMFs or dossier equivalents for US/EU approvals.
API manufacturing footprint (global categories)
Because ziprasidone hydrochloride is an established API, most named suppliers fall into one of these categories:
| Supplier type | Typical role in ziprasidone hydrochloride supply | What they sell |
|---|---|---|
| DMF-backed API manufacturer | Supplies API under regulatory filings | Ziprasidone hydrochloride API |
| Generic finished-dose manufacturer | Buys API then makes tablets/capsules | Finished product (strength-specific) |
| Global distributor | Stocks and distributes API | API lot supply via distribution agreements |
| Toll manufacturing group | Purifies, salts, packages, labels | Packaged API (sometimes with CoA-driven batch control) |
Where does the strongest evidence of actual supplier presence come from?
For ziprasidone hydrochloride, the strongest public supplier signal is the finished-dose product universe on the FDA side, because it ties a product’s manufacturer/holder to active supply obligations. The same players often appear in the API supply chain either directly or through contract relationships.
FDA product-market anchor
The FDA’s Drugs@FDA database lists ziprasidone hydrochloride-containing products and identifies the application holders and manufacturers for each listed product. These application holders are the practical starting point for supplier diligence because they control procurement and quality agreements for the API supply chain. Source: FDA Drugs@FDA (ziprasidone hydrochloride product entries). [1]
Who are the main downstream finished-dose “supplier” nodes?
For procurement planning, the finished-dose manufacturers are often the most actionable counterparties when you need reliable lot supply because they qualify suppliers through a controlled system (incoming API qualification, COA verification, stability program alignment, and cGMP batch release).
Practical mapping to supplier diligence
When buying ziprasidone hydrochloride through finished-dose channels (or through contract manufacturing), supplier diligence typically follows this structure:
- Application holder identifies the registered or qualified manufacturing sites.
- Manufacturing site receives API under approved supplier(s) list.
- API specification and analytical methods are locked to the registration.
- Change control is executed before any alternate API source is used.
This matters because switching API sources can require bridging stability and analytical verification even when the drug substance is pharmacopoeial.
What specs govern ziprasidone hydrochloride supplier selection?
Supplier selection for ziprasidone hydrochloride is driven by end-market regulatory requirements. The common decision criteria are:
| Requirement | What procurement checks | Typical evidence |
|---|---|---|
| Identity, assay, impurities | Meets ziprasidone hydrochloride API acceptance criteria | CoA and validated HPLC/GC methods |
| Particle properties | Inhalation is not relevant; for tablets it affects blend and dissolution | Particle size distribution if specified by buyer |
| Polymorph and hydrate control | Ziprasidone hydrochloride physical form can affect stability and dissolution | Solid-state characterization and batch history |
| Solvent/elemental limits | Residual solvents and elemental impurities | Compliance to ICH Q3 standards |
| GMP compliance | cGMP status and inspection history | Inspection outcomes and quality agreements |
What procurement routes exist for ziprasidone hydrochloride?
Route A: Buy API directly from an approved API manufacturer
Best when you need consistent supply for internal formulation or toll manufacturing.
Pros: direct control of supply terms
Cons: longer qualification cycle and higher QA burden
Route B: Buy API via a qualified contract manufacturer
Common for early-stage formulation or when stability and analytical support must be aligned.
Pros: faster operational start
Cons: indirect supplier transparency on API origin
Route C: Buy through finished-dose supply
Used when you do not need the API itself, only finished drug supply.
Pros: short qualification loop for your product line (or even directly as branded/generic)
Cons: you buy through the manufacturer’s supply chain
How to shortlist suppliers using regulatory traceability
A supplier shortlist is most defensible when it uses the “regulatory traceability chain”:
- Start with FDA-registered finished-dose product entries for ziprasidone hydrochloride and capture applicant/manufacturer names, application type, and listed facilities. [1]
- Cross-check whether those applicants have API relationships or vertical integration. This often shows up through corporate history, DMF ownership patterns, or public quality documents.
- Run DMF/dossier match for ziprasidone hydrochloride via regulatory repositories (US DMF, EU filings) to identify API manufacturers tied to approved submissions.
- Confirm manufacturing site cGMP compliance using inspection outcomes.
Key supplier diligence items (what contracts must lock)
Even for “commodity” APIs, ziprasidone hydrochloride supply contracts typically require tight controls:
- Change control: alternate site or synthetic route changes are treated as major changes
- Analytical comparability: method drift and impurity profile changes must be bridged
- Stability commitment: retain samples and run ongoing stability at agreed intervals
- Batch documentation: CoA, traceability, impurity reporting thresholds, and raw material sourcing declarations
- Audit rights: right to review manufacturing records and quality system
Key Takeaways
- Ziprasidone hydrochloride supply is best approached through regulatory traceability from FDA Drugs@FDA product listings to application holders and their manufacturing sites, then mapped into the underlying API qualification network. [1]
- Practical “supplier” options split into API manufacturers, API distributors, contract manufacturing nodes, and finished-dose manufacturers, with the strongest procurement leverage usually in the finished-dose nodes because they control the qualified API supplier list.
- Supplier qualification hinges on identity/assay and impurity control, solid-state form control, residual limits, and documented cGMP quality systems, with tight change-control and stability bridging requirements.
FAQs
1. Is ziprasidone hydrochloride supplied mainly as an API or as finished doses?
Ziprasidone hydrochloride is supplied in both forms. The most procurement-ready evidence typically appears through finished-dose listings on regulatory databases, then maps back to API qualification networks. [1]
2. How can I verify an API supplier for ziprasidone hydrochloride?
Use regulatory traceability: identify application holders/manufacturers in Drugs@FDA, then confirm the underlying API manufacturer through dossier/DMF matches and cGMP inspection records. [1]
3. What quality attributes most affect switching ziprasidone hydrochloride suppliers?
Impurity profile, assay, identity, residual solvent limits, and solid-state form control (which affects dissolution and stability in finished dosage forms).
4. What is the fastest route to secure ziprasidone hydrochloride supply?
Buying through a qualified finished-dose manufacturing or contract manufacturing channel often reduces qualification cycle time because the API suppliers are already qualified within the manufacturing system. [1]
5. What should be locked in a ziprasidone hydrochloride API supply agreement?
Change control, analytical comparability requirements, stability commitments, batch documentation standards, and audit/quality review rights.
References
[1] U.S. Food and Drug Administration. Drugs@FDA: Ziprasidone hydrochloride products and listings. https://www.accessdata.fda.gov/scripts/cder/daf/
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