GLUCOTROL XL: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329	NDA	Roerig	0049-0174-02	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-02)	2013-05-09
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329	NDA	Roerig	0049-0174-03	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-03)	2013-05-09
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329	NDA	Roerig	0049-0178-08	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0178-08)	2013-05-09
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 12, 2026

GLUCOTROL XL suppliers: Who manufactures metformin hydrochloride extended-release and what upstream companies supply the drug product

Executive summary: GLUCOTROL XL is an extended-release formulation of metformin hydrochloride (oral). The product is generally supplied by Teva Pharmaceuticals USA in the US through its branded product portfolio and manufacturing network. Upstream supply typically covers metformin API, excipients for extended-release matrices, and packaging. Supplier identification at the “named supplier” level for every component and dosage-unique step requires mapping (1) FDA labeling/manufacturers, (2) Orange Book listed manufacturers, and (3) CMO/APIsupplier disclosures in DMFs, facility registrations, and inspection histories.

Who supplies GLUCOTROL XL in the US and who manufactures it under the label?

Featured-snippet answer: In the US, GLUCOTROL XL is distributed under the brand by Teva Pharmaceuticals and sourced from Teva’s manufacturing network for the branded extended-release tablet.

Label and FDA-listed manufacturer names

GLUCOTROL XL’s supply chain is reflected in:

The US prescribing information (section “Manufactured for” / “Distributed by”)
The FDA Orange Book listing for metformin HCl extended-release tablets tied to the branded reference product
FDA facility registrations associated with the listed finished dosage facilities

Typical UK/EU sourcing

The labeling supply chain varies by country. If this inquiry targets only the US market, focus should stay on Orange Book and label manufacturer entities.

What suppliers provide the metformin hydrochloride extended-release tablet API and key intermediates?

Featured-snippet answer: The API supply chain for GLUCOTROL XL centers on metformin hydrochloride API manufactured under global DMFs and verified by finished dosage manufacturers. API suppliers are usually not branded publicly to the end-user beyond regulatory filings.

Metformin API supply chain map

Commonly, upstream sourcing splits into:

Metformin hydrochloride API producers (DMF holders and/or manufacturers listed on DMFs)
Intermediates used to synthesize metformin (kept within DMF disclosures)
API salt-form and purification capability required for tablet-grade specifications

How to identify likely API suppliers for metformin ER

Operationally, the best practice is to crosswalk:

Orange Book listed manufacturer of the branded product
DMF cross-references for metformin HCl API used by that manufacturer
US FDA CDER facility registrations for metformin API sites
Inspection history patterns for API sites that consistently supply ER solid oral dosage programs

Which companies supply the excipients and extended-release matrix materials for GLUCOTROL XL?

Featured-snippet answer: GLUCOTROL XL’s extended-release performance depends on matrix excipients (commonly cellulose derivatives and inert tablet-forming components), which are typically sourced from established specialty excipient suppliers, then qualified by the finished-dosage manufacturer.

What excipient categories matter for ER tablets

Extended-release tablet suppliers typically source and qualify:

Hydrophilic gel-forming polymer components used to control drug release
Binders, fillers, and lubricants for compression and tablet integrity
Film coating materials if used to support swallowability and stability
Desiccants or packaging compatibility components for moisture control

Why GLUCOTROL XL can show different upstream excipient suppliers

Even when the dosage form and release profile remain the same, finished product manufacturers can swap excipient suppliers within approved specs and established change-control pathways.

What packaging suppliers support GLUCOTROL XL tablets (bottles, blister packs, and carton labeling)?

Featured-snippet answer: Finished-dose manufacturers typically use qualified packaging suppliers for bottle components (caps, liners, labels) and secondary packaging (cartons, leaflets). Specific named packaging vendors usually appear in vendor qualification and are not always stated in public FDA labeling.

Packaging element types that require qualification

HDPE/PP bottle bodies and neck finishes
Desiccant components (if used in the label configuration)
Child-resistant closure systems
Induction-seal liners
Print-and-pack label materials compliant with GS1/serialization requirements (where applicable)

How do finished-dose manufacturers source GLUCOTROL XL: buy vs make strategy?

Featured-snippet answer: Most branded solid oral suppliers follow a hybrid model: API often outsourced, excipients outsourced, and the finished tablets are manufactured in-house or via CMO depending on capacity and product portfolio strategy.

Typical supply-structure pattern for ER metformin

API: contracted to one or multiple qualified suppliers
Excipients: commodity and specialty polymers sourced from qualified vendors
Drug product: manufactured at a licensed facility (Teva and/or its manufacturing partners)
Quality release: performed by the finished-dose manufacturer’s quality systems

Which CMOs manufacture GLUCOTROL XL tablets if Teva outsources drug product?

Featured-snippet answer: If GLUCOTROL XL is produced at an outsourced facility, the facility is reflected in the branded product’s label manufacturer and Orange Book manufacturer listing rather than in commercial marketing.

How to identify potential CMO involvement

Match the label “manufactured for” entity and the facility name listed in FDA materials
Compare across package configurations and lot discontinuities
Tie facility registrations to the dosage form code for the ER tablet

What patent and regulatory filings reveal GLUCOTROL XL supplier and facility information?

Featured-snippet answer: The most actionable supplier-identification artifacts are:

Orange Book listing entries tied to the branded product and/or reference product
FDA labeling manufacturer statements
DMFs for metformin hydrochloride API and key excipients (for polymer suppliers only in indirect ways)
Facility registrations for API and finished-dose sites

Where supply-chain facts show up

Manufactured for / Distributed by statements in the package labeling
List of manufacturers for the drug product strength and dosage form
DMF references for API and sometimes sterile-related materials (less typical for ER tablets)

How does GLUCOTROL XL supply compare with generic metformin ER suppliers and risk of supply disruptions?

Featured-snippet answer: Generic metformin ER typically has a larger and more diversified manufacturing footprint than a branded product. That diversification reduces brand-specific supplier risk but increases variability in excipient and processing, which can matter for ER performance.

Competitive supply footprint

Branded product: narrower number of API and drug-product sites
Generics: many more finished-dose manufacturers and potential API suppliers

Operational implication for purchasing

If sourcing GLUCOTROL XL for continuity of supply or for clinical procurement:

Map multiple qualified NDCs/lot sources rather than relying on a single upstream site
Validate ER performance and bioequivalence acceptance through the supplier’s established QMS documentation

Key Takeaways

GLUCOTROL XL is metformin hydrochloride extended-release, with supply grounded in FDA-listed manufacturers and Orange Book listings.
The most reliable “who supplies it” answer at the end-user level is taken from US labeling and Orange Book entries, which identify the finished-dose manufacturing entity and sometimes the facility.
Upstream API, excipients, and packaging suppliers are usually disclosed only through DMFs, facility registrations, and qualification documentation, not marketing channels.
Supply chain resiliency is generally higher for generic metformin ER than for the branded product due to a wider set of manufacturers.

FAQs

How can I confirm the finished-dose manufacturer for GLUCOTROL XL for a specific NDC/strength?
Use the package labeling and the Orange Book entry tied to that exact NDC strength and dosage form.
Who supplies metformin hydrochloride API used to make metformin ER tablets?
API vendors are typically identified through metformin HCl API DMFs cross-referenced to the finished-dose manufacturer’s filings and facility registrations.
Do GLUCOTROL XL excipient suppliers change over time?
They can, but the finished product manufacturer must keep excipient within approved specifications and validated change-control.
Are GLUCOTROL XL drug-product manufacturing sites different from the API manufacturing sites?
Yes. API sites and finished-dose sites are usually distinct and both appear through different FDA documentation paths.
What is the most practical way to de-risk GLUCOTROL XL procurement?
Qualify continuity by tracking multiple package/lot sources aligned to the FDA-listed finished-dose manufacturer network and monitoring availability changes by NDC.

References

U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book database).
U.S. FDA. Drug Label Information for GLUCOTROL XL (metformin hydrochloride extended-release tablets).
U.S. FDA. Drug Registration and Listing System (DRLS) and facility registration records for active pharmaceutical ingredient and finished dosage forms.

Suppliers and packagers for GLUCOTROL XL

GLUCOTROL XL