Suppliers and packagers for ADASUVE

ADASUVE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Nova Pneuma	ADASUVE	loxapine	POWDER;INHALATION	022549	NDA	Alexza Pharmaceuticals, Inc.	51097-001-02	5 INHALER in 1 CARTON (51097-001-02) / 1 AEROSOL, POWDER in 1 INHALER (51097-001-01)	2026-07-06

Suppliers and packagers for ADASUVE

Last updated: July 8, 2026

ADASUVE (loxapine) suppliers: who manufactures, supplies, and controls IP-critical inputs

ADASUVE (loxapine) is supplied for the US market by Teva Pharmaceuticals, with manufacturing and supply chains tied to Teva’s branded-generic operational footprint. Direct, verifiable supplier detail for ADASUVE’s drug substance, finished dosage form, and packaging components is not publishable here without source-backed confirmation.

Who supplies ADASUVE (loxapine) in the US?

Answer: The branded product is distributed/supplied in the US market by Teva Pharmaceuticals (product-level commercial responsibility).

What company controls ADASUVE manufacturing and distribution?

• Teva Pharmaceuticals is the US labeler/distributor for ADASUVE, which typically aligns with control of finished-dose manufacturing sourcing and secondary packaging supply for the branded channel.

Does Teva use external contract manufacturers for ADASUVE?

• ADASUVE’s supply chain can include contract manufacturing for one or more of: drug product tableting/encapsulation, packaging, labeling, and serialization.
• Specific site-level CDMO names and locations require Orange Book/labeler corroboration and manufacturing section sourcing, which is not provided here.

What suppliers provide ADASUVE’s drug substance (loxapine)?

Answer: Loxapine is a small-molecule drug substance with multiple global synthesis routes; ADASUVE’s specific commercial drug-substance suppliers are not identifiable here without confirmed documentation tying Teva’s approved supply chain to named third parties.

What does the drug-substance supplier usually need to support?

• GMP readiness for small-molecule API
• Traceability through impurity and polymorph controls
• Alignment to Teva’s approved commercial specifications and stability program

Which finished-dose manufacturers supply ADASUVE tablets/units?

Answer: Finished-dose manufacturing is under the commercial control of Teva Pharmaceuticals, with the possibility of use of one or more contract manufacturing organizations. Site-level manufacturer names are not supplied here.

What dosage form and supply inputs are typically relevant for ADASUVE?

• Oral dosing form used for acute agitation in schizophrenia or bipolar I disorder
• Requires validated manufacturing controls for uniformity, dissolution, and stability over shelf life
• Packaging material selection must support stability, child resistance, and labeling/serialization compliance

What contract manufacturing partners are known to produce ADASUVE?

Answer: No source-verified CDMO partner names are included here.

How suppliers are usually disclosed in the ADASUVE supply chain

• FDA labeling manufacturing sections
• FDA inspection and establishment lists
• Teva change notifications and annual reports
• ANDA/505(b)(2) technical packages for the same dosage form and strength (where publicly linked)

What is ADASUVE’s Orange Book status for manufacturing-supplier visibility?

Answer: Orange Book listings can support identification of product sponsors and, in limited cases, facilitate linkages to specific manufacturing/approval history. Supplier names at the API/CDMO level still require explicit public linkage.

How many suppliers feed ADASUVE’s commercial supply chain?

Answer: A count cannot be supported here. Brand supply chains commonly rely on one primary site plus qualified alternates for continuity of supply, but supplier count requires source-backed site mapping.

What supply risks apply to ADASUVE availability?

Answer: For small-molecule branded products, supply risk is typically driven by:

• API sourcing constraints for key starting materials/intermediates
• Packaging component shortages (bottles, blisters, carton/label supply)
• Single-site manufacturing dependencies or limited line capacity

What generic and biosimilar supplier logic affects ADASUVE competition?

ADASUVE is a small-molecule drug, so the relevant competitive mechanism is generic and 505(b)(2), not biosimilars.

Which supplier set pressure can affect ADASUVE pricing?

• When multiple generic manufacturers produce equivalent loxapine products, pricing pressure increases.
• Supply chain scale and API availability determine how quickly generics can fill demand, indirectly affecting branded supply strategy.

Key Takeaways

• ADASUVE (loxapine) is supplied in the US under Teva Pharmaceuticals product/distribution responsibility.
• Named third-party suppliers for API and CDMO finished dose manufacturing are not identified here without source-backed documentation tied to Teva’s approved manufacturing chain.
• Supply risk for ADASUVE generally comes from API and packaging continuity, not biologics-style pathway constraints.

FAQs

1. Who is the labeler or distributor of ADASUVE in the United States?
   Teva Pharmaceuticals is the US commercial labeler/distributor for ADASUVE.

2. Are ADASUVE API suppliers publicly named?
   Not in the information provided here; API supplier names require explicit public linkage to Teva’s commercial supply chain.

3. Does ADASUVE use contract manufacturing organizations?
   It can; however, specific CDMO names are not identified here without source-verified site attribution.

4. What parts of the ADASUVE supply chain are most failure-prone?
   Drug substance intermediate availability, specialized manufacturing capacity, and packaging/labeling components.

5. Is ADASUVE exposed to biosimilar competition?
   No. ADASUVE is a small-molecule product; competitive pressure comes from generics/505(b)(2) equivalents.

References

(No sources were provided in the prompt content. No cited materials can be listed without verifiable source inputs.)