Suppliers and packagers for linezolid

linezolid

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hetero Labs	LINEZOLID	linezolid	FOR SUSPENSION;ORAL	211813	ANDA	Camber Pharmaceuticals, Inc.	31722-865-25	1 BOTTLE, GLASS in 1 CARTON (31722-865-25) / 150 mL in 1 BOTTLE, GLASS	2022-10-31
Hetero Labs	LINEZOLID	linezolid	FOR SUSPENSION;ORAL	211813	ANDA	American Health Packaging	60687-754-05	1 BOTTLE, GLASS in 1 CARTON (60687-754-05) / 150 mL in 1 BOTTLE, GLASS	2023-08-20
Hikma	LINEZOLID	linezolid	FOR SUSPENSION;ORAL	200068	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0319-50	150 mL in 1 BOTTLE (0054-0319-50)	2015-06-03

Suppliers and packagers for linezolid

Last updated: April 23, 2026

Who Supplies Linezolid Across the Value Chain?

Linezolid is a small-molecule antibacterial (oxazolidinone class). Supply is split between API manufacturers (active pharmaceutical ingredient) and finished-dose (FDF) manufacturers (tablets, capsules, infusion products), plus specialty suppliers that provide excipients, packaging, and contract manufacturing support. The supplier set varies by market because regulatory approvals, site qualification, and local distribution determine who can sell into each country.

Which companies manufacture linezolid API?

Linezolid API is produced by a set of global generics and specialty API players. The most consistently referenced suppliers in commercial and regulatory contexts include:

Supplier	Typical role	What they supply in practice
Zydus Lifesciences	API manufacturer	Linezolid API and/or marketed generic intermediates in multiple markets (site-dependent)
Aarti Drugs	API manufacturer	Linezolid API for generic manufacturers
Hetero Drugs	API / API-capable	Linezolid API supply into generic portfolios
Macleods Pharmaceuticals	API / form-ready	API supply and/or finished generics depending on destination
Torrent Pharmaceuticals	API / form-ready	Linezolid generics and associated API supply chain participation
Sun Pharma	API / vertically integrated	Linezolid product lines with local manufacturing footprints in some markets

Who supplies linezolid finished dosage forms (FDF)?

Finished-dose supply is dominated by companies with approved generic products (tablets, oral suspension where offered, and infusion products in some jurisdictions). Commonly active manufacturers include:

Supplier	Dosage form presence (common)	Market behavior
Sandoz	Tablets / generics ecosystem	Brand-equivalent generic distribution in multiple regions
Mylan / Viatris	Tablets	Large-scale generic portfolio coverage
Teva	Tablets / generics	Broad distribution and tender participation
Dr. Reddy’s Laboratories	Tablets / generics	Price-competitive supply into tenders
Cipla	Tablets	Large footprint across multiple geographies
Corden Pharma / contract ecosystem	Linezolid under contract (country-dependent)	Works with brand and generic MAHs via CDMO pathways

Which regional suppliers tend to dominate purchasing in tenders?

Procurement patterns usually cluster around three groups: (1) multinational generic brands with logistics scale, (2) large Indian generics with manufacturing cost advantages, and (3) China-based manufacturers supplying export-oriented generics. In practice, procurement outcomes depend on local regulatory status (marketing authorization holders and listed products) rather than on raw manufacturing capacity alone.

What regulatory and listing systems determine who can supply?

Linezolid supply into a given market is constrained by marketing authorization and product listing status. Two key systems are:

US

• FDA Orange Book listings determine which MAHs have approved linezolid products and how those map to manufacturers and strengths. FDA Orange Book is the practical starting point for identifying approved finished-dose suppliers in the US.
• FDA product pages and labeling link directly to the approved commercial product and the MAH responsible for that product.

EU

• EMA assessment and national authority authorizations shape who can sell specific linezolid presentations in each member state.
• Local tender lists typically include products that are already authorized and stocked by local distributors.

Key implication for sourcing

Even when a company manufactures API, supply for a market is often executed through marketing authorization holders with distribution rights and locally compliant product supply chains.

Which suppliers are tied to linezolid regulatory visibility in public listings?

Public regulatory datasets reflect finished-dose MAHs and label holders more reliably than API-only producers. Linezolid generics appear across multiple major generic portfolios; the supplier who appears in a jurisdiction’s listing determines who can legally sell the product in that market.

How to map “supplier” to procurement-ready entities (what buyers actually contract)

For business contracting, “supplier” usually breaks into two different contracting targets:

1. Marketing authorization holder (MAH) / product owner

   • Supplies legally authorized product and handles labeling, pharmacovigilance responsibilities, and importation compliance where applicable.

2. Manufacturing site(s) and contract manufacturers (CMOs/CDMOs)

   • Produces product under contract for the MAH. In some cases the MAH is also the manufacturer.

API-only manufacturers can be part of the chain, but they generally do not sell into final tender channels unless they are integrated with a finished-dose authorization or through licensed distribution partners.

Key sourcing strategy by value chain

API procurement

• Buyers typically require DMF/ASMF-linked documentation (where applicable in the target jurisdiction) and a quality agreement with batch release testing and change control.
• Confirm that the API manufacturer’s site is acceptable for the buyer’s finished-dose regulatory strategy.

FDF procurement

• Buyers usually qualify based on:
  • approval status in the target country
  • product presentation (strength, dosage form, pack size)
  • stability documentation for the intended shelf life
  • ability to meet local labeling and cold-chain or handling requirements (if any presentation requires special handling)

Key Takeaways

• Linezolid supply splits between API manufacturers and finished-dose manufacturers/MAHs; tender and distribution decisions hinge on finished product authorization, not API capability alone.
• Commonly visible active suppliers in linezolid portfolios include Zydus Lifesciences, Aarti Drugs, Hetero Drugs, Macleods Pharmaceuticals, Torrent Pharmaceuticals, Sun Pharma, plus large generic FDF players such as Sandoz, Teva, Viatris, Dr. Reddy’s, Cipla, and contract manufacturing ecosystems that work through MAHs.
• The most reliable way to identify “who can supply legally” in a specific market is to use FDA Orange Book and corresponding national/EMA authorization records for the exact linezolid presentation and strength.

FAQs

1) Is linezolid supply driven more by API makers or finished-dose approvals?

Finished-dose approvals dominate. API producers matter for cost and availability, but procurement usually requires an authorized finished product in the target jurisdiction.

2) What is the most direct public source for identifying approved linezolid products in the US?

The FDA Orange Book for approved drug products and the MAH/manufacturer information tied to those approvals. [1]

3) Do API manufacturers also supply finished-dose products?

Many do in practice. Some are vertically integrated or participate in form-ready projects, but contracting into tenders typically targets an MAH with an authorized finished dose.

4) Why do suppliers differ by country for the same linezolid presentation?

Because marketing authorization status, national regulatory approvals, and local distribution qualification differ by jurisdiction.

5) What specs or controls typically matter most for buyers sourcing linezolid?

Batch release consistency, stability data aligned to the intended shelf life, and change-control governance through a quality agreement between manufacturer and buyer.

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References

[1] FDA. (n.d.). Drugs@FDA / Orange Book drug products for linezolid (oxazolidinone antibacterials). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/