Last Updated: May 6, 2026

Suppliers and packagers for generic pharmaceutical drug: metolazone


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metolazone

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Alembic METOLAZONE metolazone TABLET;ORAL 213251 ANDA Alembic Pharmaceuticals Limited 46708-532-31 100 TABLET in 1 BOTTLE (46708-532-31) 2020-12-02
Alembic METOLAZONE metolazone TABLET;ORAL 213251 ANDA Alembic Pharmaceuticals Limited 46708-532-91 1000 TABLET in 1 BOTTLE (46708-532-91) 2020-12-02
Alembic METOLAZONE metolazone TABLET;ORAL 213251 ANDA Alembic Pharmaceuticals Limited 46708-533-31 100 TABLET in 1 BOTTLE (46708-533-31) 2020-12-02
Alembic METOLAZONE metolazone TABLET;ORAL 213251 ANDA Alembic Pharmaceuticals Limited 46708-533-91 1000 TABLET in 1 BOTTLE (46708-533-91) 2020-12-02
Alembic METOLAZONE metolazone TABLET;ORAL 213251 ANDA Alembic Pharmaceuticals Limited 46708-534-31 100 TABLET in 1 BOTTLE (46708-534-31) 2020-12-02
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Metolazone: Key Suppliers and Manufacturing Footprint

Last updated: April 24, 2026

Who supplies metolazone API and what is the manufacturing footprint?

Metolazone is supplied through multiple API and finished-dose channels. Demand typically runs through:

  • Generic tablets (most market activity)
  • Direct API supply to generic manufacturers and formulators
  • Contract manufacturing for tablets and packaging

A reliable supplier map depends on whether the focus is API, finished dosage, or both. This answer is constrained to supplier lists where verifiable public sourcing exists.

Top finished-dose and distribution channels (global)

The most visible public supplier set for metolazone is through branded and generic finished-dose labels, which are distributed by large generic and specialty pharmaceutical companies and their partners. Public listings appear in regulatory product databases and market catalogs, where companies are shown as marketing authorizers or distributors rather than API manufacturers.

Examples of commonly listed finished-dose label/distribution entities

Entity type Example entities appearing in public product listings Notes
Finished-dose marketers/generics Major global generic manufacturers (varies by country) Often changes by market authorization and label version
Local distributors Country-specific wholesalers and distributors Labels and packagers differ by jurisdiction

No complete, single global “supplier for metolazone” list is consistent across jurisdictions because product registrations and distributors are country-specific.

What API suppliers exist for metolazone?

Publicly searchable supplier registers for API typically require linkage to:

  • DMF (Drug Master File) submissions
  • CEP and regulatory filings
  • Importer/MAH listings tied to specific packaging and batch releases

A complete API supplier roster cannot be compiled from the information available here without risking inaccuracies (API suppliers change and are often not fully disclosed in public product databases).

What are the most common dosage forms and how does that drive supplier selection?

Metolazone is commercially supplied primarily as:

  • Tablets (oral solid dose)
  • Strengths commonly seen across markets: 2.5 mg (also seen as 1 mg in some markets)

This matters because tablet manufacturing and packaging are usually where most contract relationships sit, while API sourcing may be upstream and less visible publicly.

Supply chain structure

Layer Typical supplier role What is usually visible
API Raw material manufacturer Often visible only via DMF/CEP-linked filings
Tablet manufacture Contract manufacturer or in-house Visible through finished-dose registrations
Packaging Local packager Visible in local regulatory listings
Distribution MAH or distributor Visible through product databases by country

How to interpret supplier lists for metolazone in regulatory databases

When you see a “supplier” in a drug database entry, it can mean:

  • Marketing authorization holder (MAH)
  • Importer
  • Distributor
  • Labeler
  • Sometimes the manufacturer of record for the finished product

For metolazone, supplier visibility is strongest at the finished-dose layer, not always at the API layer.

Practical sourcing routes for metolazone

Route A: Source finished-dose tablets

Use national regulatory databases to identify:

  • Tablet MAHs
  • Manufacturers of record for each marketed strength
  • Changes across pack sizes and label versions

Route B: Source metolazone API

Use DMF/CEP-linked information to identify:

  • API manufacturer tied to filings
  • Alternate API suppliers if multiple approvals exist for the same drug substance

Route C: Use contract manufacturing

If you need tablets and secondary packaging:

  • Select contract manufacturers with demonstrated capability for oral solid doses
  • Confirm API sourcing through your quality agreement chain

Key Takeaways

  • Metolazone supply is most consistently visible through finished-dose tablet marketing/distribution rather than full public disclosure of API manufacturers.
  • A single universal “metolazone supplier list” does not hold across countries because product authorizations and distributors vary by jurisdiction.
  • For procurement decisions, separate finished-dose suppliers from API suppliers and validate through regulatory product listings (finished dose) and DMF/CEP-linked filings (API).

FAQs

  1. What is the most common metolazone dosage form in global markets?
    Oral solid tablets.

  2. Is metolazone supply handled primarily by API suppliers or tablet manufacturers?
    Finished-dose manufacturers and distributors are most visible publicly; API sourcing is typically upstream and tied to DMF/CEP information.

  3. Why do metolazone suppliers differ by country?
    Because marketing authorizations, importers, packagers, and manufacturers of record are jurisdiction-specific.

  4. What should procurement teams confirm when sourcing metolazone tablets?
    Manufacturer of record, strength, pack configuration, and regulatory status in the target market.

  5. What is the best way to identify metolazone API suppliers?
    Trace API manufacturer identity through DMF/CEP-linked regulatory filings rather than finished-dose label entries.

Sources (APA) [1] U.S. Food and Drug Administration (FDA). Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] European Medicines Agency (EMA). European public assessment reports and EPAR/EPAR product information. https://www.ema.europa.eu/en
[3] UK Medicines and Healthcare products Regulatory Agency (MHRA). Drug product databases and licensing information. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

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