Last Updated: June 9, 2026

Suppliers and packagers for PERFOROMIST


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PERFOROMIST

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Viatris Specialty PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-1631-91 60 POUCH in 1 CARTON (0378-1631-91) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL 2021-06-22
Viatris Specialty PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-1631-93 30 POUCH in 1 CARTON (0378-1631-93) / 1 VIAL in 1 POUCH (0378-1631-32) / 2 mL in 1 VIAL 2021-06-22
Viatris Specialty PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007 NDA Viatris Specialty LLC 49502-605-30 30 POUCH in 1 CARTON (49502-605-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL 2007-10-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for PERFOROMIST

Last updated: May 30, 2026

Perforomist suppliers: who manufactures perforomist (formoterol fumarate) and who supplies raw materials

Executive summary: Perforomist is the brand name for arformoterol tartrate (not formoterol). The key “supplier” question for the product typically breaks into: (1) the FDA-approved finished-dose manufacturers listed on the label and (2) the API and key intermediate sources used by those finished-dose manufacturers. Without jurisdiction-specific labeling and Orange Book/DMF access, only the finished-dose manufacturer can be stated reliably.

Who is the finished-dose manufacturer for Perforomist (arformoterol tartrate) injection/solution?

Featured snippet: The supplier for the finished Perforomist dosage form is determined by the FDA-registered label manufacturer(s) for the specific strength and dosage form sold in the US.

What dosage form is Perforomist?

  • Perforomist is a nebulized solution containing arformoterol tartrate (long-acting β2-agonist).

How to identify the “supplier” used in practice

  • For procurement and contracting, the relevant supplier is the finished-dose manufacturer on:
    • the US FDA label (Highlights of Prescribing Information)
    • the FDA facility registration
    • purchase documentation tying the NDC to a specific lot-manufacturing site

Common commercial contracting pattern

  • One company may hold the brand and regulatory file, while another manufactures drug product.
  • Distributor/manufacturer “supplier” lists frequently change by NDC and lot.

What companies supply arformoterol tartrate API used to make Perforomist?

Featured snippet: API supply is typically handled through DMFs and/or commercial API contracts tied to the finished-dose manufacturer. Public lists are incomplete because many API sources are disclosed at the DMF level rather than on the product label.

API supply chain structure for inhaled/nebulized bronchodilators

  • Arformoterol tartrate API is produced via multi-step chemical synthesis.
  • Finished-dose manufacturers typically source API from:
    • qualified CMOs with process validation history
    • DMF-holding API producers
    • or internal upstream plants for scale-dependent supply assurance

What is the Orange Book status of Perforomist and does it affect supplier availability?

Featured snippet: Orange Book status determines generic entry and exclusivity, which can affect the number of qualified suppliers over time, but it does not directly list raw-material suppliers.

How Orange Book information links to supplier risk

  • If there is ongoing exclusivity or active patents, supplier qualification may stay narrow.
  • After patent expiry and entry, there are usually more manufacturers with different API procurement pathways.

Which generic or biosimilar products compete with Perforomist and how does that change supplier sourcing?

Featured snippet: Perforomist is small-molecule therapy, so the relevant competitive set is generics/authorized duplicates, not biosimilars.

Supplier impact mechanism

  • Generic entry increases:
    • downstream CMOs
    • API procurement options
    • bargaining leverage for distributors
  • However, the exact effect depends on whether generics are sold under multiple NDCs tied to different manufacturing sites.

When do Perforomist supply constraints or recalls change “who supplies it”?

Featured snippet: Supply changes occur when the label manufacturer’s manufacturing site is impacted (capacity, quality events) or when the NDC manufacturer changes.

Lot-based manufacturing shifts

  • It is common for a single product to move across:
    • finished-dose manufacturing sites
    • packaging sites
    • and sometimes API lots
  • That makes “supplier” identification NDC-specific and time-specific.

What delivery system manufacturers are involved in Perforomist commercialization?

Featured snippet: For nebulized products, procurement can split between:

  • drug product manufacturer (the nebulizer solution)
  • device/packaging elements (nebulizer compatibility packaging)

Packaging and administration components

  • Perforomist commercial packs can include:
    • single-unit vials
    • cartons
    • and are designed for compatibility with specific nebulizers in clinical use

Supplier due diligence checklist for Perforomist procurement

Featured snippet: For high-reliability sourcing, contract terms should cover the drug product manufacturer, not just the distributor.

Commercial terms to lock

  • NDC-specific drug product manufacturer site
  • QMS alignment and deviation handling
  • CoA and lot release testing specifications
  • supply continuity plans and backup manufacturing sites
  • regulatory status mapping (label updates, changes in supplier)

Regulatory terms

  • traceability from API through intermediate steps to drug product
  • DMF reference (where applicable) and listed manufacturer consent
  • change control notification SLAs

Key Takeaways

  • “Supplier for Perforomist” in procurement terms usually means the FDA label-listed finished-dose manufacturer for the relevant NDC.
  • API supplier names for arformoterol tartrate are typically controlled through DMFs and contracting disclosures, so they are not reliably answerable from public-facing product pages alone.
  • Supplier availability and manufacturer shifts can be NDC- and time-specific due to lot and site changes.
  • Contract due diligence should center on label manufacturer identity, lot traceability, and backup manufacturing rather than distributor branding.

FAQs

  1. How do I confirm the exact Perforomist manufacturer for a given NDC?
  2. Do Perforomist API suppliers change by lot or by site?
  3. What documents should a wholesaler provide to verify Perforomist sourcing compliance?
  4. Can Perforomist be sourced through multiple CMOs under the same NDC?
  5. How do quality events at a Perforomist manufacturing site affect distributor supply?

References

  1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (US FDA database).
  2. FDA. Drug Label (Highlights of Prescribing Information) for Perforomist (arformoterol tartrate).

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