Suppliers and packagers for LIDOCAINE

LIDOCAINE

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	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	211469	ANDA	Alembic Pharmaceuticals Limited	46708-424-30	1 TUBE in 1 CARTON (46708-424-30) / 30 g in 1 TUBE	2025-02-11
Alembic	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	211469	ANDA	Alembic Pharmaceuticals Limited	46708-424-35	1 TUBE in 1 CARTON (46708-424-35) / 35.44 g in 1 TUBE	2025-02-11
Alembic	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	211469	ANDA	Alembic Pharmaceuticals Limited	46708-424-50	50 g in 1 JAR (46708-424-50)	2025-02-11
Alembic	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	211469	ANDA	Alembic Pharmaceuticals Inc.	62332-424-30	1 TUBE in 1 CARTON (62332-424-30) / 30 g in 1 TUBE	2018-11-30

Lidocaine Drug Supply Base: Manufacturers, Source Markets, and a Practical Procurement View

Last updated: April 25, 2026

Who supplies lidocaine across dosage forms and markets?

Lidocaine is supplied through a large, mature manufacturer base covering injectable and topical dosage forms. Supply typically comes from (1) originator and large global generics, (2) regional sterile and topical specialists, and (3) API producers feeding downstream formulation plants. Below is a procurement-grade view of where the supply sits, using publicly documented manufacturing and market authorization information.

Which companies manufacture injectable lidocaine products?

Injectable lidocaine is commonly offered as lidocaine hydrochloride injection (often 1% and 2%, with different pack formats and prescriber-grade labeling). Suppliers include:

• B. Braun
  • Supplies lidocaine injection products in multiple markets (sterile parenteral portfolio).
• Hospira (Pfizer)
  • Supplies injectable lidocaine under established legacy injectable product lines in multiple countries.
• Fresenius Kabi
  • Supplies lidocaine injection as part of broader sterile injectable portfolios.
• Sandoz (Novartis)
  • Supplies generic lidocaine injections in multiple jurisdictions through its established generics infrastructure.
• Teva
  • Supplies generic injectable lidocaine products in several markets.
• Mylan (Viatris)
  • Supplies generic lidocaine injection products through Viatris’ legacy portfolio.

Which companies manufacture topical lidocaine products?

Topical lidocaine spans creams, gels, patches, and solutions for mucosal or cutaneous use. Major suppliers include:

• GlaxoSmithKline (GSK)
  • Supplies branded topical lidocaine products in some markets, depending on local licensing and formulation.
• Endo International
  • Historically active in anesthetic and topical pain product supply in multiple regions.
• Lidocaine patch and gel generic manufacturers (regional)
  • Widely sourced from European, Indian, and US generics plants depending on market authorization requirements.

Who supplies lidocaine as API and drug substance?

API supply for lidocaine is heavily diversified. Many procurement strategies treat lidocaine API as a commodity with qualified vendor lists controlled by formulation plants, especially for sterile products where contamination and particle profile control are critical.

Common characteristics of the lidocaine API supplier base:

• Multi-country API production (India, China, Europe, US)
• cGMP/US FDA and EU GMP-aligned producers supplying to formulation manufacturers
• Certificate-of-Analysis and DMF-driven sourcing for higher-control users

What is the regulatory backbone for supplier qualification?

Supplier qualification in pharmaceuticals is typically tied to regulatory submissions and facility listings. For lidocaine, the practical supplier qualification points are:

• FDA drug establishment registration and product listing for marketed products (US)
• USDMF/DMF referencing where applicable for API and drug substance
• EU GMP compliance for manufacturers supplying the EU market
• FMD/serialization and track-and-trace requirements where implemented by jurisdiction

How do you map lidocaine supply risk by dosage form?

Lidocaine’s supply risk profile differs materially by dosage form and manufacturing technology:

1) Sterile injectable lidocaine

• Higher dependency on aseptic facility capacity
• Stronger constraints on sterility assurance, hold times, and environmental controls
• More frequent qualification requirements due to cold-chain and sterility controls (if applicable by pack and stability program)

2) Topical lidocaine

• More diversified manufacturing because many products rely on non-sterile lines (creams and gels)
• Patches and medicated plasters require additional lamination/coating line control
• Often more vendor switching possible than sterile injectable, subject to bioequivalence/clinical equivalence data and local product authorization

3) Oral or mucosal lidocaine (solutions/viscous preparations)

• Usually lower aseptic constraints than injections
• Still subject to API spec control and excipient compatibility

Where do supplier and market authorizations concentrate?

Supply often concentrates where manufacturing ecosystems and approvals are established:

• United States
  • Large generics and sterile manufacturing base
  • Local product authorization drives which brands and packagers dominate
• European Union
  • GMP-aligned formulation plants with multiple authorization pathways (national and centralized depending on product)
• India and China
  • Dense API and formulation capacity
  • Widely used for generics, subject to facility qualification and submission references

What procurement artifacts determine “approved supply” for lidocaine?

For a formulation buyer, the “real” procurement artifacts are usually:

• Facility qualification package
  • GMP inspection status, quality system overview, audit results
• API/drug substance specifications
  • Identity, purity, impurity profile, water content, residual solvents (if applicable)
• Change control history
  • Stability program updates, process change filings, revalidation outcomes
• Regulatory alignment
  • DMF/CEP alignment for API (as applicable)
  • Batch release records and CoAs for commercial lots

What does a practical supplier shortlist look like (by role)?

A) Formulation product manufacturers (injectable/topical)

• B. Braun
• Fresenius Kabi
• Sandoz
• Teva
• Viatris (Mylan legacy)
• Pfizer/Hospira (in select markets)

B) Brand and legacy topical suppliers

• GSK (in some topical segments and markets)
• Endo International (in legacy segments depending on region and authorization)

C) API suppliers

• Broad multi-country pool with qualification requirements through DMF and GMP compliance
• Typically shortlisted based on whether the API is referenced in the buyer’s approved regulatory dossier and whether impurity and specification profiles meet internal targets

How does lidocaine availability typically behave during supply strain?

For mature, high-volume molecules like lidocaine:

• Supply strain usually follows sterile facility downtime, packaging constraints, or regional regulatory batch release delays, not API scarcity alone.
• Topical and non-sterile forms typically show faster substitution between qualified products, as long as the dosage form and strength match local labeling and clinical requirements.

What are the fastest paths to substitution if a supplier is constrained?

Procurement substitutions usually follow these patterns:

• Switch between manufacturers of the same strength and dosage form (for example, lidocaine hydrochloride injection at the same % and presentation, within the same route)
• Shift between generics with the same release specifications that meet the buyer’s internal quality and regulatory targets
• Temporarily expand the qualified vendor list by adding GMP-qualified plants already active in the market

Key Takeaways

• Lidocaine supply is structurally diverse, with established sterile injectable and topical formulation ecosystems and a broad API supplier pool.
• The most material supply constraint usually comes from aseptic/sterile capacity for injectable products and specialty coating/patch lines for transdermal systems.
• Procurement readiness depends on qualification artifacts (GMP status, DMF/dossier alignment where applicable, CoA batch traceability, change-control compliance), not only on brand or list price.
• For supplier selection, prioritize vendors with a track record in the same dosage form and strength, plus demonstrated batch release stability in the target market.

FAQs

1. Is lidocaine a commodity API with many qualified suppliers?
   Yes. The lidocaine drug substance market is mature and vendor-rich, with qualification tied to dossier alignment and impurity/spec compliance.

2. Which supplier category impacts sterile injectable availability the most?
   Sterile injectables are most constrained by formulation plant aseptic capacity and environmental control performance, not just by API availability.

3. Can topical lidocaine products be substituted more easily than injections?
   In many cases, yes, because topical products often rely on non-sterile manufacturing lines. Substitution still requires matching dosage form, strength, and regulatory equivalence.

4. Do large generics manufacturers and sterile specialists dominate lidocaine injection supply?
   They dominate in many markets due to established sterile manufacturing portfolios, generic registrations, and distribution scale.

5. What procurement documents matter most for vendor qualification of lidocaine?
   The key documents are GMP inspection status, API/drug substance specifications, DMF/dossier alignment where referenced, CoAs and batch release records, and change-control history.

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References

[1] U.S. Food and Drug Administration. Drug Establishment Registration and Product Listing. FDA. https://www.fda.gov/drugs/drug-establishment-registration-and-drug-product-listing
[2] European Medicines Agency. Human medicines: marketing authorisation and procedures (overview). EMA. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation
[3] U.S. FDA. Drug Master Files (DMF). FDA. https://www.fda.gov/drugs/drug-master-files-dmf