Suppliers and packagers for MAXALT

MAXALT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864	NDA	Organon LLC	78206-142-01	18 POUCH in 1 CARTON (78206-142-01) / 1 TABLET in 1 POUCH (78206-142-99)	2021-06-01

MAXALT (rizatriptan) suppliers: API, finished-dose manufacturers, and key sourcing risks

Last updated: May 29, 2026

MAXALT is rizatriptan benzoate for acute migraine treatment. Supply of MAXALT products in the US is typically split across (1) rizatriptan API producers and (2) finished-dose manufacturers that hold the FDA-approved NDA for MAXALT tablets and MAXALT-MLT (rizatriptan benzoate orally disintegrating tablets). The specific supplier roster depends on the exact strength and dosage form sold by the label distributor at the time of shipment, and it changes with contract manufacturing and secondary sourcing.

H1: MAXALT suppliers for rizatriptan benzoate API and tablets: who makes it and where is it sourced?

Which companies supply MAXALT (rizatriptan) tablets and MAXALT-MLT in the US?

Direct answer: The US market is supplied via the branded NDA product manufacturing network tied to the FDA-approved label for MAXALT and MAXALT-MLT. The practical “supplier list” for MAXALT procurement is the set of finished-dose manufacturers shown on the product label (and, for dossier-level sourcing, the manufacturing sites referenced in FDA submissions), plus API manufacturers supplying rizatriptan benzoate to finished-dose makers.

What supplier entities matter for procurement due diligence?

For MAXALT sourcing, buyers typically track:

• API (rizatriptan benzoate) manufacturer(s) supplying the finished-dose plant
• Finished-dose manufacturer(s) filling, tableting, coating, or OD-T processing (MAXALT-MLT)
• Packaging site(s) for bottle blister and carton configurations
• Quality system coverage for EU and US GMP, since many migraine brands rotate between sites

Dosage forms that create different supplier networks

• MAXALT tablets (strengths on-label vary by country and time period)
• MAXALT-MLT orally disintegrating tablets (OD-T), which often has different formulation and manufacturing equipment requirements than conventional tablets

Who manufactures rizatriptan benzoate API used for MAXALT?

Direct answer: Rizatriptan benzoate API is sourced from specialized chemical API manufacturers that produce triptan intermediates and execute final salt formation under GMP. For MAXALT, procurement needs to align the API supplier with the finished-dose NDA’s approved manufacturing chain.

API manufacturing complexity that affects supplier eligibility

Key constraints that limit the supplier pool for rizatriptan include:

• Controlled synthesis of triptan core intermediates and salt formation
• Residual solvent, impurity profile, and polymorph control for rizatriptan benzoate
• Confirming equivalence to NDA-referenced specifications used by the finished-dose NDA holder

How API sourcing changes cost and lead times

• Lock-step qualification between API and finished-dose plant can create longer onboarding timelines for alternative suppliers
• API substitution for existing commercial lots is usually constrained by comparability expectations and regulatory requirements tied to the NDA chain

Are there multiple finished-dose manufacturers for MAXALT and MAXALT-MLT?

Direct answer: Yes. Brand drug supply chains often use primary and backup contract manufacturing sites for tablets and OD-T, with shifts driven by capacity, quality performance, and economics. For MAXALT, finished-dose manufacturers are the primary “suppliers” that matter for guaranteed supply.

Why OD-T (MAXALT-MLT) often has a different supplier set

MAXALT-MLT requires:

• Orally disintegrating tablet formulation and process control
• Fast dissolution disintegration targets
• Compression and drying controls sensitive to excipient selection and humidity

As a result, OD-T production frequently sits in a different manufacturing network than conventional tablets.

What documents identify MAXALT suppliers (labeler, CMO, sites)?

Direct answer: Supplier identification for MAXALT is typically obtained from:

• The FDA label “Manufactured for” or “Manufactured by” lines that name the company/site
• FDA product listing records and establishment identifiers tied to the NDA
• Site-specific manufacturing disclosures in FDA submissions tied to product sections for tablets vs OD-T

Procurement workflow that maps “who supplies what”

A robust MAXALT supplier map is built by cross-referencing:

• Label manufacturing language by dosage form and strength
• FDA establishment listing for the listed manufacturer(s)
• Track-and-trace and lot genealogy (where available) to confirm which site produced a given lot number in distribution

Which suppliers are likely to be involved by geography (US vs EU/India/China)?

Direct answer: For a US migraine brand, the finished-dose manufacturing for commercial supply is commonly US, Ireland, or EU-based, with API sourced from global GMP chemical suppliers. API and intermediates frequently originate outside the US, while final dosage may be produced in countries with established oral solid manufacturing capacity.

Supply chain patterns by role

• API role: China and India are common sourcing regions for many small-molecule triptan APIs, assuming GMP parity and NDA qualification.
• Finished-dose role: contract manufacturing in the EU or the US is common to satisfy regulatory and distribution constraints.

What supplier risks exist for MAXALT continuity (API shortages, OD-T capacity)?

Direct answer: MAXALT supply risk concentrates in:

1. limited qualified API supply for rizatriptan benzoate,
2. OD-T-specific manufacturing capacity for MAXALT-MLT,
3. batch release and impurity profile drift across alternative sites.

Key risk vectors for business continuity

• API batch-to-batch impurity variance leading to longer analytical release times
• Capacity constraints at OD-T plants due to high excipient handling sensitivity
• Regulatory friction when switching API sources without pre-positioned comparability evidence

How strong is the MAXALT supplier base vs other triptans?

Direct answer: The supplier base for branded triptans tends to be narrow at the level of NDA-qualified manufacturing and API qualification, but MAXALT’s brand status often supports multiple qualified manufacturing sites for finished dose compared with niche molecules. Competitive risk rises when API producers reduce capacity or reallocate to higher-margin products.

What to compare for supplier resilience

• Number of qualified finished-dose plants on the FDA-approved label chain
• Number of qualified API suppliers supporting the NDA chain
• Distributor lot history variability (site of manufacture and lot timing)

What does MAXALT exclusivity and generic competition imply for suppliers?

Direct answer: Generic entry does not eliminate the need for qualified suppliers, but it usually increases the total number of API and dosage manufacturers in the market. For MAXALT specifically, the branded NDA supply chain can face pricing pressure that shifts procurement toward lower-cost suppliers while maintaining NDA-required quality standards.

How generic competition changes the supplier landscape

• Branded CMOs may lose volume and retool, which can tighten short-term capacity for backup supply
• API suppliers may prioritize multiple brands, creating cross-product scheduling risk

Key takeaways

• MAXALT “suppliers” in procurement terms are the finished-dose manufacturers named on the FDA label plus the API manufacturers supplying rizatriptan benzoate to those NDA-qualified plants.
• Supplier availability differs between MAXALT tablets and MAXALT-MLT OD-T, often driving separate manufacturing networks.
• Supply continuity risk is most concentrated in API qualification scope and OD-T capacity, with lot release and impurity profile drift acting as the main operational chokepoints.

FAQs

1) Who is the contract manufacturer of MAXALT tablets?

Finished-dose manufacturer(s) are identified on the FDA label “Manufactured for/Manufactured by” lines for MAXALT tablets and should be treated as the primary procurement suppliers.

2) Who manufactures MAXALT-MLT orally disintegrating tablets?

MAXALT-MLT supplier identification is split from conventional MAXALT tablet manufacturing because OD-T processing is typically handled by a different NDA-qualified site.

3) Is rizatriptan benzoate API sourced domestically for MAXALT?

Rizatriptan benzoate API for branded triptans is commonly global. The NDA-qualified API supplier(s) must match the approved manufacturing chain used by the finished-dose manufacturer.

4) What causes MAXALT shortages in supply chain?

Supply interruptions typically trace to API production constraints, OD-T manufacturing capacity limitations, or slower batch release due to impurity and testing variability.

5) Do generic rizatriptan products use the same suppliers as MAXALT?

Generic manufacturers often use different qualified manufacturing sites and may source API from alternative producers, while still requiring GMP compliance and regulatory approval.

References

1. U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
2. FDA Drug Label (MAXALT; rizatriptan benzoate). FDA labeling and manufacturing information.