Last Updated: June 15, 2026

Suppliers and packagers for GLIPIZIDE AND METFORMIN HYDROCHLORIDE


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GLIPIZIDE AND METFORMIN HYDROCHLORIDE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Heritage GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078728 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-115-01 100 TABLET, FILM COATED in 1 BOTTLE (23155-115-01) 2010-06-29
Heritage GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078728 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-115-10 1000 TABLET, FILM COATED in 1 BOTTLE (23155-115-10) 2010-06-29
Heritage GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078728 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-116-01 100 TABLET, FILM COATED in 1 BOTTLE (23155-116-01) 2010-06-29
Heritage GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078728 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-116-10 1000 TABLET, FILM COATED in 1 BOTTLE (23155-116-10) 2010-06-29
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Last updated: April 25, 2026

Who supplies Glipizide and Metformin Hydrochloride for pharmaceutical manufacturing?

What drug form matters for sourcing?

“Glipizide and metformin hydrochloride” can be supplied as:

  • Active pharmaceutical ingredients (APIs): glipizide (usually immediate-release) and metformin hydrochloride (immediate-release or extended-release variants).
  • Finished dosage forms (FDCs): fixed-dose combinations in tablets (most commonly for type 2 diabetes).
  • Intermediates and finished-dose contract manufacturing inputs: where an API maker supplies upstream materials or where a toll manufacturer produces tablets under customer branding.

Because supplier lists differ materially by API vs FDC vs contract manufacturing, the only supplier set that can be stated as “suppliers of the pharmaceutical drug” without mixing roles is API and FDC supply by established manufacturers and large distribution networks that routinely sell into global pharmaceutical supply chains.


Which companies supply metformin hydrochloride API?

Metformin hydrochloride is widely sourced. Common API suppliers include large generics and API producers that distribute globally:

Supplier Supply scope Notes
Merck (EMD Serono / Merck KGaA group entities) Metformin (API and/or finished forms depending on jurisdiction) Global brand and generics presence; metformin is a legacy product in the Merck portfolio.
Teva Metformin (API/finished goods depending on market) Operates across generics manufacturing and commercial supply.
Mylan / Viatris Metformin Generic global manufacturing and distribution footprint.
Sandoz (Novartis) Metformin Sandoz supplies generics across multiple markets.
Torrent Pharmaceuticals Metformin (API and/or finished forms) Indian generics manufacturing footprint.
Sun Pharma Metformin Large generics manufacturer with broad product coverage.
Dr. Reddy’s Laboratories Metformin Generic manufacturing and supply network.
Accord Healthcare Metformin (region-dependent) UK/EU-focused generics manufacturing and supply.

Which companies supply glipizide API?

Glipizide is also widely sourced, though the supplier set is smaller than metformin due to demand profile:

Supplier Supply scope Notes
Teva Glipizide (API and/or finished goods depending on market) Generic supply chain presence.
Sandoz (Novartis) Glipizide Generics manufacturing and distribution.
Mylan / Viatris Glipizide Large generics portfolio.
Torrent Pharmaceuticals Glipizide India-based manufacturing with international distribution.
Sun Pharma Glipizide Generic manufacturing footprint.
Dr. Reddy’s Laboratories Glipizide Generic supply into multiple regions.
Accord Healthcare Glipizide UK/EU footprint with product manufacturing and supply.

Which suppliers support combination products (glipizide + metformin)

Fixed-dose combinations (FDCs) are typically manufactured by generics companies and branded generics suppliers. For supply chain planning, companies with strong FDC execution and distribution tend to be the most relevant targets.

Supplier Combination scope Notes
Teva Glipizide + metformin (market dependent) Large FDC generics platform.
Sandoz (Novartis) Glipizide + metformin Generics manufacturing and regional launches.
Viatris (Mylan) Glipizide + metformin Broad generics portfolio.
Sun Pharma Glipizide + metformin Global generics supply.
Dr. Reddy’s Laboratories Glipizide + metformin FDC manufacturing presence.
Torrent Pharmaceuticals Glipizide + metformin Indian generics supplier with international reach.
Accord Healthcare Glipizide + metformin EU/UK generics supply chain.
Cipla Glipizide + metformin India generics manufacturer with international distribution.

How do you shortlist “real” suppliers for procurement

Procurement qualification for glipizide and metformin hydrochloride typically depends on whether the buyer needs:

  • API (ANDAs/DMFs, traceability, polymorph and specs, supply continuity), or
  • Finished tablets (GMP batch release, local regulatory listing, packaging and labeling compliance), or
  • Both (common for manufacturers using contract formulation).

For API procurement, supplier qualification typically centers on:

  1. DMF availability and compliance history (FDA/EMA submission readiness where applicable).
  2. GMP inspection status for API facilities.
  3. Spec alignment for the exact strength and release type (metformin IR vs XR).
  4. Supply continuity (capacity, lead times, multi-source strategy).

For FDC procurement, qualification typically centers on:

  1. GMP readiness for the combination product (tablet formulation, blend uniformity).
  2. Co-packaged strength consistency (glipizide mg + metformin mg per tablet).
  3. Stability program evidence for finished product shelf-life.
  4. Distribution and packaging compliance (local labeling requirements by market).

What procurement artifacts matter for glipizide + metformin supply

For business use, the following artifacts usually determine whether a supplier can enter a bid list or requires requalification:

For APIs

  • Certificate of Analysis (CoA) format including impurities and residual solvents.
  • Analytical methods alignment (HPLC assay, impurity profiling).
  • Polymorph/crystal form controls for glipizide and metformin forms as applicable.
  • Raw material traceability (starting materials and catalysts where specified by DMF).

For FDC tablets

  • Batch Manufacturing Record (BMR) release evidence under GMP.
  • In-process controls (blend uniformity, hardness, friability).
  • Dissolution specifications appropriate to metformin IR/XR design.
  • Stability data (accelerated + long-term, container closure system match).

Supplier map by commercialization route

Buyer objective Best supplier target profile Why it fits
Source APIs directly API manufacturers with global distribution and DMF-backed compliance Minimizes reformulation and regulatory friction when switching suppliers.
Source finished tablets Generics FDC manufacturers with established regulatory listings Reduces time-to-market and shortens batch qualification cycle.
Dual-source strategy One API supplier per ingredient plus one tablet supplier (or contract manufacturer) Avoids supply shocks while maintaining formulation control.

Key Takeaways

  • Glipizide and metformin hydrochloride are supplied by global generics and API-capable manufacturers; the relevant supplier set depends on whether procurement targets API or fixed-dose tablets.
  • Widely recurring commercial supply companies for metformin include Merck, Teva, Viatris, Sandoz, Sun Pharma, Dr. Reddy’s, Torrent, Accord.
  • Glipizide supply is concentrated among similar large generics platforms: Teva, Sandoz, Viatris, Sun Pharma, Dr. Reddy’s, Torrent, Accord.
  • For the combination glipizide + metformin, sourcing typically comes from FDC-capable generics manufacturers such as Teva, Sandoz, Viatris, Sun Pharma, Dr. Reddy’s, Torrent, Accord, Cipla.
  • Shortlisting should be driven by GMP inspection readiness, DMF/CoA specs, and product form match (metformin IR vs XR).

FAQs

1) Can I source both glipizide and metformin from one company?

Yes, large generics manufacturers and distribution partners often supply both actives or the combined finished tablets. API sourcing can also be split across suppliers if your qualification strategy requires it.

2) Are metformin extended-release products supplied by the same channels as metformin immediate-release?

Often they share commercial suppliers, but manufacturing and specification controls differ. Metformin XR typically requires form-specific dissolution and stability evidence.

3) Does glipizide supply depend on tablet strength or release profile?

Yes. Glipizide strengths can vary by market, and spec requirements depend on the intended dosage form.

4) What is the fastest procurement path: APIs or fixed-dose tablets?

Fixed-dose tablets are usually faster for route-to-market because formulation, stability, and unit-dose quality are already packaged and batch-released as a finished product.

5) What supplier quality checks matter most for APIs?

GMP status, impurity/spec alignment, CoA consistency, and traceability documentation (often tied to DMF compliance) matter most.


References

[1] FDA. (n.d.). Drugs@FDA: Glipizide; Metformin hydrochloride. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] EMA. (n.d.). European public assessment reports and product information for metformin and glipizide-containing products. European Medicines Agency. https://www.ema.europa.eu/
[3] DailyMed. (n.d.). Metformin hydrochloride and glipizide product labeling. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/
[4] Merck. (n.d.). Product and generics portfolio information for metformin. Merck. https://www.merckgroup.com/
[5] Viatris. (n.d.). Generic product portfolio information (metformin; glipizide; combination products). Viatris. https://www.viatris.com/

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