Last Updated: May 10, 2026

Suppliers and packagers for MYDAYIS


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MYDAYIS

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063 NDA Takeda Pharmaceuticals America, Inc. 54092-468-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-468-01) 2017-06-20
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063 NDA Takeda Pharmaceuticals America, Inc. 54092-471-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-471-01) 2017-06-20
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063 NDA Takeda Pharmaceuticals America, Inc. 54092-474-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-474-01) 2017-06-20
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063 NDA Takeda Pharmaceuticals America, Inc. 54092-477-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-477-01) 2017-06-20
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Who Supplies Mydayis (amphetamine mixed salts) for U.S. Markets?

Last updated: April 25, 2026

What is Mydayis’s drug and manufacturer?

Mydayis is a branded extended-release product containing amphetamine mixed salts (CII). In the U.S., the prescribing information lists Alexza Pharmaceuticals as the company associated with the brand and Takeda Pharmaceuticals U.S.A., Inc. as the marketing party in the current distribution chain.

Brand / generic identity

  • Product: Mydayis (amphetamine mixed salts)
  • Type: Extended-release (ER) stimulant, CII
  • Active drug class: Central nervous system stimulant (amphetamine salts)

Commercial party shown on U.S. labeling

  • Marketing authorization holder / U.S. marketer (label): Takeda Pharmaceuticals U.S.A., Inc.
  • Brand company on label: Alexza Pharmaceuticals
    Source: U.S. prescribing information for Mydayis [1].

Who are the key “suppliers” in the Mydayis chain?

In pharmaceutical supply chains, “supplier” most often maps to (1) the marketing/brand authorization holder, (2) the manufacturer(s) listed for drug product, and (3) distribution/labeling entities. For Mydayis, the labeling ties the brand to Takeda in U.S. commercialization.

1) Brand authorization and U.S. commercialization supplier

  • Takeda Pharmaceuticals U.S.A., Inc. (U.S. marketing party listed in prescribing information) [1].

2) Brand company listed on the U.S. product label

  • Alexza Pharmaceuticals (listed on prescribing information as the brand-related company) [1].

What manufacturing entities are listed for Mydayis on the label?

The prescribing information for Mydayis identifies:

  • A U.S. commercial/labeling party (Takeda) and the brand company (Alexza) [1].

Manufacturing-site level identification (drug substance and finished dosage plant) The specific finished dosage manufacturer name(s) and sites are typically listed in the prescribing information under sections like “Manufactured for” or “Manufactured by,” and sometimes in the package labeling. That exact “manufacturer of record” and the site-level address details are required to name the true finished-goods supplier(s) precisely.

This response is limited to what the provided sources support. It does not include plant-level manufacturer names beyond what the Mydayis labeling explicitly ties to the brand and U.S. marketing chain in the cited source.

How does the Mydayis supplier map to public reference databases?

For investors and R&D sourcing screens, the most reliable primary “supplier” identifiers for a listed medicine are:

  • the U.S. label marketing company
  • the brand authorization holder
  • the drug product manufacturer(s) listed for labeling

For Mydayis, the cited prescribing information supports the first two items.

Mydayis: supplier mapping (label-supported)

Supplier role Entity Evidence
U.S. marketing party Takeda Pharmaceuticals U.S.A., Inc. Mydayis prescribing information [1]
Brand-related company on label Alexza Pharmaceuticals Mydayis prescribing information [1]

What procurement implication does this have?

If a buyer is qualifying suppliers for Mydayis supply reliability (wholesale/Rx channel) or for partnership sourcing, the labeling-supported commercial chain points to:

  • Takeda as the U.S. commercialization anchor
  • Alexza as the brand company referenced on labeling

That makes Takeda the practical entry point for:

  • supply agreements
  • pricing and distribution arrangements
  • label-driven vendor qualification workflows

Key Takeaways

  • Mydayis is marketed in the U.S. through Takeda Pharmaceuticals U.S.A., Inc. as shown on the prescribing information. [1]
  • Alexza Pharmaceuticals is listed on the Mydayis prescribing information as the brand-related company. [1]
  • The label-supported supplier roles that can be stated with precision from the cited source are the U.S. marketing party and the brand company; plant-level manufacturer naming requires explicit “manufactured by/for” label text, which is not fully reproduced in the cited excerpt. [1]

FAQs

  1. Is Mydayis manufactured by Takeda?
    Takeda is the U.S. marketing party listed on the prescribing information. The label excerpt supports marketing, not plant-level manufacturing attribution. [1]

  2. Who holds the Mydayis brand on the U.S. label?
    The Mydayis prescribing information lists Alexza Pharmaceuticals as the brand-related company. [1]

  3. What is the active ingredient in Mydayis?
    Amphetamine mixed salts in an extended-release formulation. [1]

  4. How can procurement teams identify the correct commercial supplier for Mydayis?
    Use the U.S. marketing party on the prescribing label. For Mydayis, that is Takeda Pharmaceuticals U.S.A., Inc. [1]

  5. Does the supplier list include drug substance makers?
    This response only substantiates label-supported brand/marketing entities from the cited prescribing information. [1]


References

[1] Takeda Pharmaceuticals U.S.A., Inc. Mydayis (amphetamine mixed salts) prescribing information. U.S. FDA label.

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