Suppliers and packagers for METAXALONE

METAXALONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695	ANDA	Actavis Pharma, Inc.	0591-2341-01	100 TABLET in 1 BOTTLE (0591-2341-01)	2017-06-19
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695	ANDA	St. Mary's Medical Park Pharmacy	60760-093-20	20 TABLET in 1 BOTTLE, PLASTIC (60760-093-20)	2017-11-10
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695	ANDA	St. Mary's Medical Park Pharmacy	60760-093-30	30 TABLET in 1 BOTTLE, PLASTIC (60760-093-30)	2017-11-10
Actavis Labs Fl Inc	METAXALONE	metaxalone	TABLET;ORAL	203695	ANDA	St. Mary's Medical Park Pharmacy	60760-093-90	90 TABLET in 1 BOTTLE, PLASTIC (60760-093-90)	2017-11-10

Suppliers for the Pharmaceutical Drug Metaxalone: API, Key Intermediates, and Finished-Dose Manufacturing Landscape

Last updated: May 26, 2026

Metaxalone supply typically splits into (1) API sourcing and (2) finished-dose contract manufacturing. The supplier universe for Metaxalone is constrained by whether products are marketed as generic tablets versus branded entries, and by whether the supply is built around common tablet strengths and downstream packaging formats. Supplier identification and enforceable procurement options are most reliable when tied to FDA labeling and Orange Book listings for specific NDC strengths, then mapped to associated manufacturers on the drug product and listing entities.

Who supplies metaxalone API and what are the common sourcing pathways?

Metaxalone is an orally administered small-molecule muscle relaxant. In practice, supply chains for small-molecule generic drugs are structured around API manufacturers (and API traders) that support multiple downstream tablet formulators under contract. For procurement decisions, the highest-signal approach is to map each commercially marketed NDC strength to its listed drug-product manufacturer(s) and then trace those firms through their likely API supply arrangements (through DMFs, supplier disclosures in filings, and public manufacturing/label data).

API sourcing structure for metaxalone

Common pathways seen across generic small molecules include:

• API manufacturing under an FDA DMF (Type II for drug substance) with one or more named downstream holders.
• API brokerage/trading where the drug product manufacturer sources from a qualified supplier network without public naming of the exact API plant on label.
• Process intermediates that are sourced separately and assembled by the API manufacturer, often with multiple regional suppliers for key intermediates.

What procurement teams typically validate for metaxalone API

• DMF linkage to the specific manufacturer of the API.
• CoA traceability and testing packages (identity, assay, impurities).
• Residual solvent and polymorph controls relevant to the final tablet formulation stability.
• Regulatory status alignment (DMF acceptance history and inspection record).

Typical constraints

Metaxalone tablets require stable API lots for compression and film-coating compatibility, which can limit the number of qualified API sources for specific tablet strengths.

Which companies manufacture metaxalone tablets for US marketing?

Finished-dose manufacturers for Metaxalone tablets are identified in the US via FDA’s Orange Book listings (by NDC strength) and on the label. For procurement, each strength must be treated as its own supply lane because manufacturing sites and packaging vendors can differ by NDC.

Drug product manufacturer mapping: the practical way to identify suppliers

• Start with Orange Book listings for each Metaxalone NDC strength.
• Extract the “Applicant/Holder” and “Manufacturer” entries tied to each NDC.
• Validate against labeler/manufacturer blocks on packaging images and FDA label review documents.
• Cross-check whether a given product is:
  • A single source product with one manufacturing site, or
  • A multi-source arrangement with multiple manufacturing sites over time.

Supply chain impact by NDC strength

• Tablet strengths drive formulation parameters (excipient levels, compression profile, and dissolution targets).
• Packaging formats drive secondary packaging and label artwork vendors.

What does the Orange Book say about metaxalone drug product and patent-linked supply?

Metaxalone’s supplier readiness in the US depends on whether competing products are protected by patents, exclusivity, or both. Patent estate and FDA exclusivity can affect whether additional manufacturers can enter quickly, and it influences how supply risks concentrate among fewer firms.

What to look for on the Orange Book

For each Metaxalone strength:

• NDC listing
• Applicant/Drug Product Manufacturer
• Patent numbers and listed claims (composition, method of use, and formulation)
• Exclusivity codes (if any)
• Regulatory pathway and approval type

Why patent-linked listings matter for suppliers

When patent protection limits generic competition, the supplier base can narrow. That increases lead-time volatility and can shift bargaining power toward the remaining contract manufacturers and API suppliers.

What suppliers exist for metaxalone contract manufacturing of tablets?

For a new entrant or for procurement planning, contract manufacturing is usually the critical bottleneck because it requires:

• validated tablet processes,
• chemistry and formulation transfer packages,
• stability programs for the specific excipient system,
• and a consistent quality agreement structure.

Contract manufacturing supplier selection criteria

• Demonstrated prior experience with similar tablet platforms (immediate-release compression products).
• Ability to manage impurity profiles and tighten specifications for metaxalone.
• Analytical method capability (HPLC/related impurity methods and dissolution testing).
• Quality agreement execution, audit acceptance, and batch release timelines.

Common procurement outcomes

• Multiple CTM candidates for packaging and labeling.
• A smaller set of qualified CTMs for tablet compression and coating if the product has specific dissolution or stability constraints.

How do you identify the real metaxalone supplier list for procurement and due diligence?

The most defensible supplier list in the US is built from an evidence chain rather than a generic “supplier directory” approach. The chain is:

1. Orange Book NDC strength listing to identify the drug product applicant/holder and manufacturer(s).
2. FDA label “Manufactured for” or “Distributed by” blocks for the marketed NDC.
3. DMF-based mapping where the drug product manufacturer points to the drug substance manufacturer(s) in filings or technical documentation.
4. Quality and compliance checks (GMP inspection history and current manufacturing status).

When do metaxalone exclusivity and patent terms affect supplier availability?

Supplier availability tightens when fewer generic competitors can legally manufacture and market due to patent coverage or exclusivity triggers. That shifts the market to a concentrated set of firms.

Exclusivity and patent-driven supply narrowing

• Brand protection and blocking patents reduce entrants.
• Paragraph IV challenges can change timing by enabling earlier generic launch if litigation and settlement permit it.

Procurement timing risk

• Lead times can compress only after new manufacturing sites can legally launch and qualify for distribution.
• Quality and regulatory transfer can take longer than legal launch, especially for tablet manufacturing.

What are the generic entry and Paragraph IV risk considerations for metaxalone supply?

For companies evaluating additional supply sources or entry:

• Paragraph IV litigation can delay manufacturability or restrict distribution depending on the settlement and court outcomes.
• Even after legal clearance, the operational readiness of CTMs (process validation and batch release testing) can lag.

How this affects sourcing

• When fewer firms are active, procurement depends on fewer API and tablet manufacturing plants.
• New supplier approvals become a gating factor for continuity of supply.

What formulations are supplied for metaxalone tablets and what does that mean for suppliers?

Metaxalone is supplied primarily as an oral immediate-release tablet product in fixed strengths. Supplier qualification is strength-specific because excipient composition and processing parameters must hit dissolution and stability acceptance.

Formulation and manufacturing implications

• Film coating (if applicable by product) requires tight control of coating solution viscosity and drying conditions.
• Tablet hardness and friability controls drive compression parameters.
• Stability testing sets long-term impurity trend expectations that the API lot must support.

Commercial implications: how supplier concentration impacts metaxalone pricing and availability

When the active supplier set is small, procurement risk rises:

• higher price volatility,
• longer lead times for API and contract manufacturing slots,
• increased variability in batch release timelines.

What procurement teams monitor

• Backlog signals from CTMs.
• API lead-time and safety stock strategy.
• Inspection outcomes and change-control activity at the API and tablet manufacturing sites.

Key Takeaways

• Metaxalone supply is best evaluated by NDC-strength mapping to Orange Book drug-product manufacturers, then traced through likely API sourcing arrangements and DMF-linked drug substance supply.
• Supplier concentration rises when patent or exclusivity barriers limit generic competition, increasing continuity and pricing risk.
• Contract manufacturing is the operational bottleneck for tablet supply, so due diligence should prioritize CTM capability for the exact tablet strengths and stability/dissolution requirements.

FAQs

1) How do I find the exact metaxalone drug product manufacturer for a specific NDC strength?
Use the Orange Book entry for that NDC strength and confirm the manufacturer block on the current FDA-labeled package insert or label.

2) Are metaxalone tablet strengths manufactured by the same supplier across all NDCs?
Not always. Strength-specific manufacturing and packaging can differ even when the same product form is sold.

3) What documents are most useful to validate metaxalone API suppliers?
FDA DMF records tied to the drug substance, plus the drug product manufacturer’s technical documentation and quality agreements.

4) Can a legal generic launch automatically mean immediate supply availability?
No. Operational readiness of the tablet manufacturing site and batch release testing often lag the legal timeline.

5) What is the biggest supplier risk for metaxalone procurement?
Concentration risk: a small active supplier set can create lead-time and batch release volatility.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drug Approvals and Databases: Drug and Device Information. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases-drug-and-biologics/