Last updated: May 25, 2026
Glumetza (metformin hydrochloride) suppliers: who manufactures, supplies, and fills the tablets?
Glumetza is a branded, extended-release (ER) metformin hydrochloride tablet marketed by Horizons/Glumetza brand owners under Shire legacy and currently supplied through downstream manufacturing and packaging vendors. The practical supplier landscape is split between: (1) contract manufacturers that make the ER matrix tablets, and (2) contract packagers/labelers that handle unit-dose packaging, cartons, and bottle labeling for the US commercial supply chain.
Summary of supplier archetypes for Glumetza ER tablets
- API source: metformin hydrochloride bulk API made by multi-purpose API producers and sold into branded ER tablet supply chains.
- Drug-product manufacturing: tablet compression and ER-matrix formation under GMP at contract manufacturing sites (or the brand’s dedicated internal facilities where applicable).
- Film coating / ER excipient blending: manufacturing steps tied to the specific ER composition and particle-size/excipient specs used for Glumetza.
- Packaging: bottle/case packaging, NDC labeling, lot tracking, and serialization-ready workflows for US distribution.
Who supplies glumetza tablets in the US market?
Direct commercial “supplier” answers for Glumetza depend on whether the question is about API, tablet manufacturing, or packaging. In the US, branded supply chains typically publish the labeler/distributor in FDA labeling and the manufacturing site in prescribing information, while actual process vendors often remain controlled by NDA/DMF confidentiality and current good manufacturing practice change control.
Where to verify the actual manufacturing site
- US FDA prescribing information (manufacturing/packaging sections).
- FDA Orange Book record for Glumetza (drug product listing and related applicant/manufacturer data).
- NDC directory and labeler identity (brand owner vs. manufacturer labeler).
- Lot-specific CGMP inspection histories tied to named manufacturing sites (public in FDA inspection databases).
What companies manufacture Glumetza ER tablets?
Glumetza is an ER dosage form, so supplier eligibility in practice is constrained by:
- ER-matrix formulation know-how (excipient system, coating/embedding method, and tablet density targets)
- validation of dissolution profiles specific to metformin ER products
- ability to produce consistent tablet hardness, friability, and controlled release kinetics across scale
What typically appears in filings
- A named manufacturer (site) for “manufactured for” and “distributed by” statements in labeling.
- Potential secondary packaging sites for unit-dose and bottle packaging.
Which API suppliers produce metformin hydrochloride for Glumetza?
Metformin hydrochloride API is widely sourced globally. In a branded ER tablet program, API procurement usually comes from:
- large-scale chemical manufacturers with DMFs or supplied via commercial API channels under QMS controls
- upstream suppliers that can meet ICH Q3A/Q3B and metformin-specific specs (impurity profile, residual solvents, polymorph management where relevant)
Key supply-chain constraint for ER tablets
- API particle size and impurity profile can impact blending, tablet uniformity, and dissolution behavior. ER tablet makers therefore lock down API specs and incoming QC acceptance limits.
What contract manufacturing organizations (CMOs) supply ER metformin tablets?
For ER metformin brands broadly, CMOs that win these programs must support:
- ER formulation blending and controlled release manufacturing under cGMP
- dissolution method development and ongoing release testing equivalency
- stability programs for ER tablet shelf-life claims
Typical CMO roles in Glumetza-like supply chains
- granulation/blending of ER excipients with metformin HCl
- tablet press and film coating (if applicable)
- packaging line qualification and label-control systems
- batch record management and change control
Orange Book status: does Glumetza have multiple listed strengths with different manufacturers?
Glumetza is marketed in multiple ER strengths, and Orange Book listings can show:
- the listed drug and the application holder
- whether there are multiple listed strengths under the same application
- whether there are different “manufacturers” tied to each strength or packaging configuration
Featured snippet answer
- Orange Book status should be used to map which applicant/manufacturer holds the Glumetza drug product listing per strength and to identify whether any parallel manufactured product versions exist.
What patent or exclusivity factors affect supplier and generic entry risk for Glumetza?
Supplier and competitive risk are tied to IP and regulatory status:
- listed patents tied to the branded drug product and formulation
- whether there are relevant method-of-use or formulation patents that constrain “generic design-around” strategies
- Paragraph IV filings that can trigger settlements and temporary exclusivity barriers, which can tighten supply availability for brands and delay generics
Commercial impact on suppliers
- If generic entry is delayed by litigation/settlements, branded supply contracts can remain at prior volumes.
- If generics enter early, branded demand typically shifts down, pressuring capacity planning and raw material procurement.
How do packaging and labeling suppliers factor into Glumetza availability?
Even when tablet manufacturing is stable, packaging bottlenecks can affect fill-finish schedules:
- bottle and label availability
- NDC-specific labeling workflow and lot tracking
- serialized packaging requirements depending on distribution channels
Supplier categories
- primary packager (bottling and labeling)
- secondary cartoning/case packer
- logistics and warehouse fulfillment partners (often not named in drug label but visible in distribution networks)
What US distribution model applies to Glumetza suppliers?
US branded distribution typically follows:
- wholesaler distribution through major pharma wholesalers (McKesson, Cardinal, AmerisourceBergen, depending on current contract structure)
- hospital/IDN channel distribution with separate fulfillment and forecasting requirements
- specialty pharmacy routing for certain payer channels (less common for metformin than for oncology specialty drugs)
Supplier contracts influence:
- allocation behavior during supply constraints
- lead times for packaging materials
- ability to support sudden batch size changes during FDA inspection-driven remedial actions
How does Glumetza compare with other metformin ER brands for supplier concentration risk?
Metformin ER competitors include other branded ER metformin products and authorized generics in segments where branded exclusivity has expired.
Supplier concentration pattern
- ER tablet manufacturing is capacity-constrained relative to immediate-release because of tighter dissolution profile requirements.
- If a small number of sites can reliably meet profile specs, supply risk concentrates.
Business read-through
- For procurement and continuity planning, buyers should evaluate:
- number of qualified manufacturing sites for the branded product
- contingency packaging capacity
- historical supply interruptions and FDA recalls linked to manufacturing/packaging lots
Key Takeaways
- “Supplier” for Glumetza should be mapped by function: API sources, ER tablet manufacturers, and packaging/labelers, not just the brand’s labeler/distributor.
- The most reliable public mapping is through FDA labeling, Orange Book drug product listings, and NDC directory labeler/manufacturer fields by strength.
- Supplier concentration risk in ER metformin exists mainly at the tablet manufacturing and dissolution-profile validation layer, with packaging bottlenecks a secondary driver.
FAQs
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How can I identify the actual tablet manufacturing site for Glumetza on FDA labeling?
Check the “Manufactured for” / “Distributed by” and “Manufactured at” sections in the US prescribing information, then cross-map the site name to FDA records.
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Does Orange Book list different Glumetza manufacturers for different strengths?
Orange Book can list strengths under the same application but may show different manufacturer/packager associations; verify per strength.
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Are metformin hydrochloride ER tablet suppliers limited to a few CMOs?
ER metformin has fewer fully qualified CMO sites than IR metformin due to dissolution-profile and ER formulation controls.
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What records show bottle labeling and NDC-specific packaging responsibility?
NDC directory labeler/manufacturer fields and the packaging/labeling statements in the prescribing information.
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How does Paragraph IV litigation typically affect supply planning for metformin ER brands like Glumetza?
Settlements and exclusivity windows can delay or accelerate generic substitution, which changes branded volume forecasts and procurement schedules.
References (APA)
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA. (n.d.). NDC Directory. U.S. Food and Drug Administration.
- FDA. (n.d.). Prescribing Information / Labeling for Glumetza (metformin hydrochloride) extended-release tablets. U.S. Food and Drug Administration.
