Suppliers and packagers for generic pharmaceutical drug: FERRIC MALTOL

FERRIC MALTOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320	NDA	Shield TX (UK) Ltd	73059-001-10	1 BOTTLE, PLASTIC in 1 CARTON (73059-001-10) / 10 CAPSULE in 1 BOTTLE, PLASTIC	2021-07-01
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320	NDA	Shield TX (UK) Ltd	73059-001-60	1 BOTTLE, PLASTIC in 1 CARTON (73059-001-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC	2021-07-01

Suppliers and packagers for generic pharmaceutical drug: FERRIC MALTOL

Last updated: May 25, 2026

Ferric Maltol Drug Suppliers (API and Finished Product): Who Provides the Raw Material and Who Manufactures Doses?

Ferric maltol is supplied in two primary commercial forms for R&D and market supply: (1) ferric maltol API (often supplied as a chemical substance under controlled specifications) and (2) finished oral products (marketed formulations, usually as ferric maltol capsules or tablets depending on territory). In patent and exclusivity terms, supply chain decisions track the product form and the specific salt/grade being requested, because regulatory and quality dossiers are typically built around a named drug substance and manufacturer.

What companies supply ferric maltol API (drug substance) for pharmaceutical use?

Featured-snippet answer: Ferric maltol API sourcing is typically handled by specialty chemical manufacturers and contract manufacturing supply chains that provide pharmaceutical-grade material with CoA, impurity profiles, and DMF support. In practice, buyer shortlists are built from firms that have demonstrated ability to provide controlled batches, EHS documentation, and compliance documentation aligned with EU GMP and/or US cGMP expectations.

Common API supply pathways

• Chemical manufacturers supplying ferric maltol as pharmaceutical-grade bulk chemical
• Distributors selling relabeled material from upstream API sources
• CMOs that can supply API or perform early-stage manufacturing for clinical and commercial supply

API specifications that determine supplier fit

• Ferric maltol assay and impurity profile (process impurities are the gating item in audit outcomes)
• Residual solvents and water content specifications
• Particle size or polymorph controls if the supplier’s commercial form is designed for solubility and stability

Which suppliers provide finished ferric maltol products (capsules/tablets) by country?

Featured-snippet answer: Finished ferric maltol products are supplied by pharmaceutical manufacturers and their local distributors under marketing authorization holders (MAHs). Finished product availability varies by country due to brand ownership, labeling, and reimbursement status.

What buyers must map in a supplier search

• MAH and marketing authorization holder in the target market
• Dosage form and strength (capsule vs tablet; mg strengths)
• Launch status and pack configuration
• Whether supply is direct from the MAH site, through a licensing partner, or via a CMO line

How do ferric maltol suppliers differ for clinical trial vs commercial scale manufacturing?

Clinical and commercial sourcing diverges at the quality and documentation layer.

Clinical trial supply

• Usually via clinical-stage manufacturers or CMOs experienced with comparator/clinical drug supply
• More emphasis on batch traceability, analytical method readiness, and documentation timelines for IND/CTA readiness

Commercial supply

• Requires scale-up stability data and consistent impurity control
• Requires established batch release throughput and cold-chain or packaging constraints if applicable

What documentation does an API supplier need to provide for ferric maltol to support regulatory submissions?

Featured-snippet answer: Regulatory-grade ferric maltol API supply requires a full chemistry and quality data package, typically coordinated through a Drug Master File (DMF) pathway in the US or relevant European equivalents.

Typical dossier components used in submissions

• Certificate of Analysis (CoA) template and batch-specific CoA history
• Specifications (assay, related substances, residual solvents, water)
• Analytical method summaries and validation status
• Stability study summaries for the drug substance form supplied
• Source and manufacturing route description adequate for quality reporting

What are the main quality and audit risks when qualifying ferric maltol suppliers?

Featured-snippet answer: The main audit risks are inconsistent impurity profiles, insufficient process controls for related substances, and incomplete method transfer readiness for routine batch release.

Audit hotspots

• Impurity generation linked to ferric salt and ligand chemistry variations
• Solvent and drying process control
• Polymorph or hydrate form controls that can change dissolution behavior

How does ferric maltol manufacturing route affect supplier qualification?

Ferric maltol is synthesized through coordination chemistry based on ferric ions and maltol derivatives. Supplier-to-supplier differences show up in upstream steps, solvent systems, and isolation/purification.

Route attributes that impact quality

• Choice of ferric source and salt form
• Purification steps that remove related ligands and byproducts
• Filtration and drying conditions that control final solid-state attributes

Are there supplier or regulatory constraints unique to ferric maltol drug substance?

Featured-snippet answer: Constraints usually come from drug substance quality expectations, not from special excipient handling.

Practical constraints

• Batch-to-batch variability in related substances is a recurring supplier-qualification driver for oral iron-based actives
• Packaging and moisture control matter because oral solid stability can be sensitive to humidity exposure

What generic or biosimilar supply risks affect ferric maltol availability?

Ferric maltol is a small-molecule oral therapy, so the dominant competition risk is generic competition and parallel supply rather than biosimilar substitution.

Risk pattern

• If a market relies on a small number of API suppliers, procurement volatility becomes the main availability risk
• Patent and exclusivity status can shift who is eligible to supply finished products in some jurisdictions, but API supply continuity is usually broader than finished product eligibility

Key Takeaways

• Ferric maltol supply splits into ferric maltol API sourcing and finished-product manufacturing tied to MAH and local authorization structures.
• Supplier qualification is driven by impurity control, analytical method readiness, and solid-state quality consistency more than by packaging constraints.
• For decision-grade procurement, buyers should map API grade, regulatory dossier support (DMF-style quality package readiness), and audit history tied to related substances and stability.

FAQs

1. How do I qualify a new ferric maltol API supplier for GMP compliance?
2. What impurity profile items are most critical for ferric maltol API acceptance?
3. Do ferric maltol suppliers differ by polymorph or hydrate form that impacts dissolution?
4. Can a distributor supply ferric maltol API for regulatory submissions, or must the API manufacturer be identified?
5. What documentation is required to cross-reference ferric maltol API batches to regulatory filings?

References

1. None.