Suppliers and packagers for MAXALT-MLT

MAXALT-MLT (rizatriptan benzoate orally disintegrating tablets) is marketed by Merck and is supplied through the Merck commercial supply chain, with manufacturing and intermediate supply executed by contract manufacturers named on FDA submissions and commercial manufacturing records. Public-facing supplier detail at the “API producer” level is limited because the Orange Book typically lists only the drug product manufacturer(s), not every upstream API or excipient supplier.

What companies supply MAXALT-MLT (rizatriptan MLT) tablets to Merck?

Direct answer: The FDA drug product manufacturer(s) for MAXALT-MLT are listed in the Orange Book as the approved finished dosage form manufacturers. Upstream API and excipient suppliers are not consistently disclosed in the Orange Book.

Orange Book-centric supplier view

• Lookups for “MAXALT-MLT” in the Orange Book identify the approved drug product labeler and the NDA holder.
• The “Manufactured by” field in Orange Book product listings identifies finished-dose manufacturing site(s) tied to Merck’s application.

Which Orange Book drug product manufacturers are listed for MAXALT-MLT?

Direct answer: Orange Book listings must be used to extract the exact “manufacturer” entities per strength and dosage form. Without the specific Orange Book listing text for MAXALT-MLT (NDA and product entry), the manufacturer set cannot be stated accurately.

Does MAXALT-MLT use multiple manufacturing sites or just one?

Direct answer: Many branded solid oral products have at least two GMP manufacturing sites over time due to scale-up and supply continuity, but the presence of multiple sites for MAXALT-MLT must be confirmed from the Orange Book listing history and FDA CMC supplements.

What suppliers provide the rizatriptan API for MAXALT-MLT?

Direct answer: The API supplier is not reliably disclosed as a named entity in the Orange Book. API manufacturers are typically disclosed through:

• DMF (Drug Master File) references in FDA labeling and submissions,
• CMC supplement filings,
• or industry databases that index DMFs to named manufacturers.

Which API DMF routes are commonly used for rizatriptan?

Direct answer: Rizatriptan benzoate is typically supplied as an isolated API under a controlled DMF route or through Merck’s qualified supply chain. Specific DMF holders and API makers must be read from FDA submission references or DMF-index datasets.

What excipient and packaging suppliers matter for MAXALT-MLT stability and disintegration?

Direct answer: For orally disintegrating tablets, the key material categories affecting disintegration time and mechanical integrity are:

• superdisintegrants (tablet breakup),
• binders and matrix formers (fast disintegration vs. strength balance),
• diluents/fillers (tablet hardness),
• lubricants (flow and compression),
• and blister components (moisture and oxygen barrier).

Which excipient classes are most critical for ODT performance?

Direct answer: Excipient selection and grade control are critical for ODTs. For MAXALT-MLT, excipient identity and grades are defined in the approved formulation in the FDA label and manufacturing records; the component suppliers are typically not listed in Orange Book.

What packaging suppliers are used for MAXALT-MLT blister cards?

Direct answer: Packaging suppliers are generally not enumerated in Orange Book product listings. They are disclosed through CMC packaging sections and commercial manufacturing records.

Who makes MAXALT-MLT under contract manufacturing (CDMO) arrangements?

Direct answer: If contract manufacturing is used, the CDMO is usually identified as the drug product manufacturer/site in the Orange Book listing. Whether the same site is used continuously across time requires Orange Book history.

How to identify the CDMO from FDA-listed data

Direct answer: Use:

• Orange Book “Manufacturer” entries for each strength and dosage form, and
• label “Manufactured for” lines. If different label revisions reference different sites, the supplier set changes.

What is the Orange Book status of MAXALT-MLT and why it affects supplier behavior?

Direct answer: Orange Book status affects generic and authorized generic entry timing, which in turn affects Merck’s procurement risk posture (multi-sourcing vs. single sourcing) but does not directly reveal upstream excipient or API suppliers.

Does patent or exclusivity status drive supply contracts?

Direct answer: It can. As the branded product approaches expiration of key exclusivity/patents, companies increasingly hedge through:

• additional drug product manufacturing sites,
• additional API sources,
• tighter inventory planning around long-lead packaging and ODT-critical excipients.

Which generic entrants could disrupt the supplier landscape for MAXALT-MLT?

Direct answer: Generic entry typically brings additional finished-dose suppliers but does not automatically name API suppliers for the brand.

What generic entry risk exists for rizatriptan ODT?

Direct answer: For a comprehensive risk map, the Orange Book exclusivity and patent expiration schedule must be evaluated per NDA and each listed patent family.

Competitive landscape: how MAXALT-MLT supply compares with other rizatriptan formulations

Direct answer: MAXALT (immediate release tablets), MAXALT-MLT (ODT), and any related rizatriptan generic products may use different formulation and packaging supply chains. ODT supply depends heavily on moisture barrier packaging and disintegration-performance excipient supply.

MAXALT vs MAXALT-MLT supplier differences

• MAXALT (tablet) supplier stack emphasizes compression/binding and coating (if any).
• MAXALT-MLT (ODT) emphasizes disintegrant selection and blister barrier.

Supplier decision checklist for procurement and licensing

Direct answer: When diligence or licensing requires supplier names (API maker, excipient maker, packaging converter), procurement teams typically validate:

1. Orange Book-listed finished-dose manufacturer(s) per strength
2. FDA label “Manufactured for” and any site-specific language
3. DMF holder and reference lists for the API
4. Supplier qualification status of ODT-critical excipients
5. Packaging barrier test protocols and supplier of record for blister components

MAXALT-MLT supplier data table (what can be stated from public FDA indexing)

Key Takeaways

• Public FDA Orange Book data can identify the finished-dose manufacturer(s) for MAXALT-MLT, but it usually does not name upstream API or excipient suppliers.
• ODT supply is procurement-sensitive because excipients and blister barrier components drive disintegration and moisture stability.
• The fastest authoritative supplier identification uses Orange Book manufacturer entries and label manufacturing language; upstream supplier-of-record typically requires DMF and CMC submission tracebacks.

FAQs

1) Who is the NDA holder for MAXALT-MLT?
Merck is the NDA holder/marketed-product labeler for MAXALT-MLT.

2) Are MAXALT-MLT API suppliers listed in the Orange Book?
No. Orange Book typically lists the approved drug product manufacturer(s), not upstream API producers.

3) What determines disintegration performance for MAXALT-MLT?
The approved formulation composition, including disintegrant system and tablet compression parameters, plus blister moisture barrier integrity.

4) Can multiple manufacturing sites supply MAXALT-MLT over time?
Yes, and the presence of multiple sites must be checked in Orange Book product listings and label revisions.

5) Where do licensors find the real supplier-of-record for API and excipients?
Through DMF references (API) and CMC qualification packages for excipients and packaging components referenced in manufacturing sections.

References

1. FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”) product listings for MAXALT-MLT (rizatriptan benzoate orally disintegrating tablets). (Accessed 2026-05-29).
2. U.S. Food and Drug Administration. Drug label for MAXALT-MLT (rizatriptan benzoate) (current version). (Accessed 2026-05-29).