Suppliers and packagers for generic pharmaceutical drug: Amisulpride

Amisulpride

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510	NDA	Acacia Pharma Ltd	71390-125-20	10 CARTON in 1 PACKAGE (71390-125-20) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-21) / 2 mL in 1 VIAL, SINGLE-DOSE	2020-02-27
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510	NDA	Acacia Pharma Ltd	71390-125-50	10 CARTON in 1 PACKAGE (71390-125-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-51) / 4 mL in 1 VIAL, SINGLE-DOSE	2020-02-27

Amisulpride Suppliers and Contract Manufacturing Landscape: Who Makes It, Where It’s Sold, and What to Validate for Supply Risk

Last updated: May 27, 2026

Amisulpride is a widely used antipsychotic API with a broad global supplier base for both the active pharmaceutical ingredient and finished-dose products. The most decision-relevant supply questions for procurement and licensing are (1) API source qualification (particle size, polymorph/grade, residuals), (2) regulatory status and inspection history for manufacturing sites, (3) finished-dose strength and dosage-form coverage, and (4) whether an alternative supplier can support your filing and commercial timeline.

Which companies supply amisulpride API worldwide?

Answer: Amisulpride API sourcing is concentrated among large Indian and Chinese chemical manufacturers and specialized API houses that can supply multiple grades. For any specific “supplier list,” procurement must map the relevant regulatory listings (DMFs/CEP holders) to your target markets.

Common supplier geographies for amisulpride API

• India: major generic API manufacturing footprint; frequent DMF/CEP pathways for EU and partner filings.
• China: high-volume API production with large-scale intermediates capability.
• Europe: smaller niche coverage, often as secondary sourcing or formulation-focused capacity.
• Emerging hubs: Turkey and Eastern Europe occasionally support finished-dose supply, less often primary API.

What to validate in an amisulpride API supplier audit

• Grade and specs: amisulpride particle size distribution (if used to control dissolution), assay, related substances.
• Solid-state control: polymorph form and stability (supplier should provide evidence of form control).
• Residuals: ICH-relevant residual solvents, metals, and genotox-relevant impurities where applicable.
• Route consistency: changes in intermediates and catalysts can affect impurity profile and impurity class.
• Regulatory readiness: DMF/CEP holder status for the target jurisdictions, plus GMP certificate scope for the exact molecule.

Who supplies amisulpride tablets and what dosage forms are covered?

Answer: Finished-dose amisulpride products are typically supplied by branded and generic manufacturers using either in-house API or contracted API. Dosage forms are mainly oral tablets; market availability by strength varies by country.

Typical finished-dose coverage by strength

• Common tablet strengths include 50 mg, 100 mg, 200 mg, and 400 mg depending on country label.

Procurement checklist for finished-dose supply

• Confirm tablet strength, scoring, and excipient system for your local clinical and interchangeability needs.
• Validate stability program and packaging configuration.
• Ensure GMP status for the finished-dose site and alignment with the regulatory filing.

How do contract manufacturing and API sourcing usually split for amisulpride?

Answer: For most generics, the supply chain splits into (1) an API supplier (primary GMP API site) and (2) a formulation manufacturer that holds the final dosage GMP and the regulatory dossier content for product release.

API first, formulation second

• API suppliers deliver the active under defined specs and batch traceability.
• Formulators manage granulation/compression, blending, coating (if applicable), and final release testing.

Common failure points in amisulpride supply substitution

• Different impurity profiles leading to failed batch release.
• Different particle size or polymorph impacting dissolution and bioequivalence performance.
• Excipient changes shifting dissolution and tablet hardness behavior.

What regulatory listings show legitimate amisulpride suppliers for your market?

Answer: Legitimate supplier selection is anchored to regulatory listings: FDA DMF status for US pathways, and EU/UK CEP and GMP confirmations for Europe. Your supplier must match the listing to the specific API manufacturer and site.

Market mapping you should use for supplier qualification

• US: FDA DMF holder or US-registered API manufacturing site.
• EU/UK: CEP holders and GMP certificates for the API site.
• National registries: locally approved finished-dose manufacturers and their sourcing declarations.

What is the best way to identify qualified amisulpride API suppliers for licensing?

Answer: Use a two-layer screen: regulatory dossier linkage first, then technical and commercial qualification.

Step 1: Dossier linkage

• Confirm the supplier is tied to an approved or filed API dossier (DMF/CEP) for the target countries.

Step 2: Technical qualification package

• CoA format history, full spec sheet, impurity declarations, stability data relevant to your shelf-life targets.

Step 3: Batch and change-control readiness

• Evidence that the supplier has robust change control for source, route, and solid-state parameters.

Which markets have the highest amisulpride supply concentration risk?

Answer: The highest concentration risk occurs where procurement depends on a small number of API sources that also serve multiple markets from the same GMP sites.

Risk indicators to monitor

• Single-site reliance for API.
• Recent GMP remediation or suspension history at the API plant.
• Tight supply periods tied to raw intermediate availability.

How strong is supply redundancy for amisulpride API compared with other antipsychotic APIs?

Answer: Amisulpride generally has higher redundancy than niche antipsychotics due to its older established use and broader generic manufacturing footprint, but site-level redundancy still varies.

Practical implication

• You can usually qualify alternates faster at the API molecule level than for more complex delivery systems, but formulation interchangeability depends on your equivalence testing strategy.

What supplier due diligence reduces late-stage regulatory and litigation risk?

Answer: The main commercial risk in amisulpride supply is last-mile regulatory readiness, not molecule availability.

Due diligence items that matter for dossiers

• Consistency of API specs across lots used in pivotal batches.
• Compliance documentation: GMP scope matching API or drug substance.
• Documented impurity profile comparability after any upstream change.

Timeline: how fast can you switch amisulpride API suppliers?

Answer: Switching speed depends on whether you are staying within the same approved API source used in your filing, versus qualifying a new API supplier.

Typical qualification timelines (procurement planning)

• Same API source, different lot: can be days to weeks if the supplier runs standard CoA release and batch controls.
• New API source with regulatory linkage: commonly months due to comparability and regulatory documentation updates.
• New API plus formulation process changes: longer timelines due to dissolution/Biopharm and CMC alignment.

Key Takeaways

• Amisulpride API supply is typically sourced from established generic API manufacturers, most commonly in India and China, with finished-dose products supplied by generic and branded manufacturers using contracted or in-house API.
• Supplier selection should be driven by regulatory dossier linkage (DMF/CEP and GMP certificate scope), then validated with solid-state, impurity, residuals, and particle size evidence.
• The biggest execution risks are grade/polymorph differences and impurity profile shifts, which can break batch release or create equivalence issues.
• Supply redundancy is usually better than for niche antipsychotics, but site-level risk can still be high.

FAQs

1. Which document proves an amisulpride API supplier is acceptable for EU filings?
   CEP and the corresponding GMP certificate for the API manufacturing site.

2. Can amisulpride tablets be made interchangeable if the API supplier changes?
   Yes in principle, but only after CMC comparability and, where required, dissolution and bioequivalence strategy alignment.

3. What API quality attributes most often cause amisulpride batch release failures?
   Related substances, residual solvents/metals, and solid-state or particle-size related dissolution differences.

4. What dosing strengths are most commonly marketed for amisulpride tablets?
   Common labels include 50 mg, 100 mg, 200 mg, and 400 mg depending on country.

5. How do I reduce procurement risk if only one API site qualifies my dossier?
   Pre-qualify one or more alternate API suppliers under a documented comparability protocol and align their specs with your established release criteria.

References

1. International Council for Harmonisation (ICH). (n.d.). ICH guidelines (quality, impurities, and residual solvents). https://www.ich.org/
2. European Medicines Agency (EMA). (n.d.). CEP and regulatory guidance. https://www.ema.europa.eu/
3. U.S. Food and Drug Administration (FDA). (n.d.). Drug Master Files (DMF) and drug substance guidance. https://www.fda.gov/