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Suppliers and packagers for CUVPOSA
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CUVPOSA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Merz Pharms | CUVPOSA | glycopyrrolate | SOLUTION;ORAL | 022571 | NDA | Merz Pharmaceuticals, LLC | 0259-0501-16 | 1 BOTTLE in 1 CARTON (0259-0501-16) / 473 mL in 1 BOTTLE | 2013-01-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Cuvposa (Glycopyrrolate) Suppliers: Who Manufactures Cuvposа Drug Product and Who Supplies Key Components
Cuvposa (glycopyrrolate) supplier coverage hinges on (1) the FDA-approved drug product manufacturers listed for each marketed strength and dosage form, and (2) upstream API and excipient sourcing. Public-facing “supplier” lists are incomplete because FDA labeling and Orange Book do not enumerate every component vendor. The most operationally useful supplier view is therefore the FDA drug-product and manufacturing-site picture by labeler/manufacturer.
Who are the approved Cuvposa (glycopyrrolate) drug product manufacturers?
Answer: The controlling “supplier” set for commercialization and regulatory compliance is the FDA labeler/manufacturer(s) shown in the Cuvposa prescribing information and tied to FDA drug product listings, including each marketed strength. These manufacturers can change over time via contract manufacturing and site transfers.
What does the FDA label typically identify for Cuvposa suppliers?
- Label holder (the company responsible for the marketed product)
- Manufacturing sites for finished dosage form (and sometimes packaged-by sites)
- GMP contract manufacturing changes as sites rotate
How to map Cuvposa suppliers by strength and dosage form
A practical supplier table is built by cross-referencing:
- FDA drug product listing (NDC-level manufacturer and manufacturing site)
- Prescribing information “Manufactured for” / “Distributed by”
- Any disclosed changes in label revisions over time
Supplier mapping table (FDA-listed drug product sources):
Not provided because the required FDA listing inputs (NDCs/labeler/manufacturer by strength) were not included in the request.
Which companies supply glycopyrrolate API for Cuvposa?
Answer: Cuvposa uses glycopyrrolate as the active pharmaceutical ingredient. API “supplier” identification is not typically shown publicly in consumer-facing labeling. API vendors can be identified only from filings (DMFs), procurement disclosures, or supplier audits, none of which are part of the request.
What upstream suppliers matter most for glycopyrrolate
- API synthesis route vendor (DMF holder or API manufacturer)
- Salt/form control (glycopyrrolate form consistency)
- Impurities and polymorph control (spec-dependent)
- GMP compliance and change-management history
How many API suppliers typically exist for a niche pediatric anticholinergic
- Usually a small set of API manufacturers because glycopyrrolate is specialized and DMFs consolidate supply.
- Contract manufacturing can also split drug product and packaging responsibilities even when API sources remain stable.
API supplier table:
Not provided because specific DMF/API-manufacturer data for glycopyrrolate was not included in the request.
What excipient and component suppliers are used in Cuvposa formulation?
Answer: Excipients vary by dosage form and strength. Cuvposa is an oral solution product, so excipients likely include vehicles and stabilizers appropriate for solution stability and pediatric use. Public labeling commonly lists excipients by name, but not the manufacturing vendors.
Which excipient categories drive vendor risk
- Solubilizers/co-solvents and viscosity modifiers (stability and taste masking)
- Preservatives (microbial control)
- Buffering agents (pH stability)
- Packaging compatibility (bottle material and closure system)
How excipient “supplier” changes show up commercially
- Label updates and rolling changes in supplier lot traceability
- Internal quality agreements with contract manufacturers
- Occasional packaging configuration changes that affect supply
Excipient supplier table:
Not provided because the specific Cuvposa excipient list and supplier/vendor mapping were not included in the request.
What contract manufacturers supply Cuvposa oral solution?
Answer: Contract manufacturing is common for oral liquids. The “supplier” most relevant to operational continuity is the GMP finished dosage manufacturer at the NDC level.
Where contract manufacturers show up
- FDA drug product listing manufacturing site
- Label “Manufactured by” and “Distributed by” language
- Inspection histories linked to manufacturing sites (not vendors)
Contract manufacturer list:
Not provided because the NDC-by-site dataset for Cuvposa was not included in the request.
Is there a biosimilar or generic supplier landscape for Cuvposa?
Answer: Cuvposa is a small-molecule drug (not a biologic), so the main competition is generic oral glycopyrrolate products. Supplier discussions therefore focus on:
- Originator labeler manufacturing sites
- Generic manufacturers and their sites at approval
How supplier competition affects availability
- Generic supply depends on API and capacity ramp
- Shortages typically propagate via manufacturing site outages and API constraints rather than “licensing” supplier disputes
Generic supplier landscape table:
Not provided because specific generic NDCs/ANDA approvals for glycopyrrolate oral solution were not included in the request.
What are the Orange Book and patent listings implications for Cuvposa supply?
Answer: Orange Book listings affect whether generic entrants are blocked or licensed, indirectly affecting supplier diversity. But patent status does not enumerate component vendors.
How Orange Book status can constrain supply
- If exclusivity or unexpired patents block generics, supplier diversity stays low.
- When exclusivity ends, multiple ANDA manufacturers can enter, expanding supplier options.
Orange Book status table:
Not provided because Orange Book data for Cuvposa (listed patents/exclusivities) was not included in the request.
Key Takeaways
- “Supplier” for Cuvposa in practical regulatory and supply-chain terms means the FDA-listed finished drug product manufacturer(s) for the marketed NDCs and strengths.
- API and excipient vendor identification is not reliably available from public labeling alone; it typically requires DMF-level and procurement-level inputs not provided here.
- To build an actionable supplier map, the operational baseline is NDC-level manufacturing sites and labeler/manufacturer identities.
FAQs
- Which NDCs map to which Cuvposa manufacturing sites?
- Do Cuvposa labelers use multiple contract manufacturers across strengths?
- Who holds glycopyrrolate DMFs that could indicate API suppliers for Cuvposa?
- What excipients are listed for Cuvposa oral solution, and which supplier categories are most stability-critical?
- How does generic entry for oral glycopyrrolate affect Cuvposa’s supply risk and procurement options?
More… ↓
