Last updated: May 27, 2026
PROAIR RESPICLICK (albuterol sulfate) is supplied through a branded manufacturing and distribution chain anchored by the product’s FDA sponsor and contract manufacturing footprint. The most reliable way to identify “suppliers” for a prescription inhalation product is the FDA labeling “Manufactured for” / “Distributed by” lines, plus Orange Book and assignment-level patent records that tie product authorization to specific manufacturing sites.
H1 does not provide sufficient information to identify specific supplier names, sites, and drug-substance vendors from the inputs available.
Who supplies PROAIR RESPICLICK (albuterol sulfate inhalation powder) in the US?
Featured answer: The supplier identity is determined by the FDA label’s “Manufactured for” / “Distributed by” entries and the FDA SPL/labeler information for the approved NDA.
What labeler/distributor fields identify the supply chain?
- NDA labeler (company responsible for the drug product listing)
- “Manufactured for” (contract manufacturer or marketing authorization holder)
- “Distributed by” (US commercialization/distribution entity)
- Package NDC label data (ties to specific labeler and sometimes to specific manufacturing site codes)
What contract manufacturers make PROAIR RESPICLICK?
Featured answer: Contract manufacturers for PROAIR RESPICLICK must be verified via label “Manufactured by for” lines and site-specific manufacturing disclosures in regulatory filings.
What evidence is used to name the manufacturing plant?
- FDA label “Manufactured for” and address block (site location)
- Site-specific inspections and manufacturing authorizations (where disclosed)
- Public patent assignments that identify manufacturing-related inventions tied to product sites
Who supplies the albuterol sulfate drug substance used in PROAIR RESPICLICK?
Featured answer: Drug substance suppliers are not reliably inferred from marketing company branding; they require supplier listings in regulatory submissions or validated through drug-substance characterization packages and cGMP sourcing disclosures.
Typical disclosure channels
- NDA chemistry section exhibits (rarely public in detail)
- DMF/ASMF submissions that list manufacturers (not consistently public unless referenced and searchable)
- Labeling and regulatory documents that name only the drug product manufacturer, not the bulk API source
Which companies are the key suppliers for inhaled albuterol products like PROAIR RESPICLICK?
Featured answer: For “like” products, supplier sets overlap at the level of formulation and packaging operations, but API sourcing can differ by product.
What overlaps most often in albuterol inhalation powder supply chains
- DPI device engineering and component sourcing
- Powder blending/filling under inhalation powder controls
- Metered-dose performance verification and container closure systems
What is the Orange Book status of PROAIR RESPICLICK and how does it affect supplier identification?
Featured answer: Orange Book listings indicate authorized product and can be used to anchor the NDA/labeler. Patent and exclusivity listings do not always list supplier names, but they can constrain which entities hold the NDA rights and which manufacturing lots are authorized.
How Orange Book data is used
- Link the NDA to current holder and listed patents
- Map patents to assignees that often correlate with manufacturing and formulation responsibilities
- Identify whether there are platform/process patents that imply specific manufacturing know-how
What generic or authorized alternative products share the same suppliers?
Featured answer: Suppliers and contract manufacturers can overlap across ANDA approvals using shared facilities, but exact supplier linkage must be validated via label manufacturing and NDC-specific listing records.
How to assess shared manufacturing without guessing
- Compare “Manufactured for” address blocks across competing inhalation powders
- Confirm whether the same site code or facility address appears across products
Key takeaways
- PROAIR RESPICLICK “supplier” identification must be verified from FDA labeler/manufacturer/distributor fields and site-specific manufacturing disclosures.
- API (albuterol sulfate) sourcing is not reliably determined from branded product branding and requires regulatory traceability (labeler + NDA + DMF/ASMF references).
- Patent/Orange Book linkage supports NDA-holder mapping but does not, by itself, name upstream drug substance vendors.
FAQs
- How do I find the FDA labeler for PROAIR RESPICLICK to identify the product supplier?
- Do PROAIR RESPICLICK manufacturing sites show up in public FDA label text?
- Can albuterol sulfate API suppliers be determined from Orange Book listings?
- Which records confirm the contract manufacturer for PROAIR RESPICLICK powder filling and device assembly?
- If a supplier makes multiple albuterol inhalation powders, what evidence ties them to the same manufacturing address?
References (APA)
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- U.S. FDA SPL (Structured Product Labeling) public datasets (labeler/manufacturer fields).
