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Suppliers and packagers for generic pharmaceutical drug: LIDOCAINE HYDROCHLORIDE
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LIDOCAINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Thea Pharma | AKTEN | lidocaine hydrochloride | GEL;OPHTHALMIC | 022221 | NDA | Thea Pharma Inc. | 82584-792-01 | 1 TUBE in 1 CARTON (82584-792-01) / 1 mL in 1 TUBE | 2022-12-01 |
| Thea Pharma | AKTEN | lidocaine hydrochloride | GEL;OPHTHALMIC | 022221 | NDA | Thea Pharma Inc. | 82584-792-25 | 25 TUBE in 1 CARTON (82584-792-25) / 1 mL in 1 TUBE | 2022-12-01 |
| Afaxys | LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 215132 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-940-41 | 25 VIAL, MULTI-DOSE in 1 CARTON (23155-940-41) / 20 mL in 1 VIAL, MULTI-DOSE (23155-940-31) | 2025-10-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: LIDOCAINE HYDROCHLORIDE
Who Supplies Lidocaine Hydrochloride to the Pharma Market?
What supply chains deliver lidocaine hydrochloride?
Lidocaine hydrochloride (API and related intermediates) is supplied through three main channels: (1) global API manufacturers producing finished API, (2) specialty chemical producers supplying upstream intermediates, and (3) regional distributors stocking finished API. For sourcing strategy, the practical split is between (a) API manufacturers with DMF/EDMF footprints in major regions and (b) traders/distributors that aggregate inventories and provide localized logistics.
Which suppliers produce lidocaine hydrochloride API?
Below is a consolidated view of suppliers that are active in producing and commercializing lidocaine hydrochloride or lidocaine HCl API at industrial scale.
| Supplier | Corporate / Group | Role in lidocaine supply | Evidence of market presence (examples) |
|---|---|---|---|
| Aurobindo Pharma | Aurobindo | API manufacturer | Publishes product and API documentation for lidocaine-related products in major markets and sells anesthetic-active APIs through its API portfolio. |
| Hetero Drugs | Hetero | API manufacturer | Lists lidocaine HCl in its drug substance portfolio and supplies injectable/anesthetic lines via API and finished-dose relationships. |
| Mylan / Viatris | Viatris | Finished-dose + API supply ecosystem | Supplies lidocaine products through established global channels; frequently aligned with API sourcing/outsourcing networks. |
| Hospira / Pfizer supply chain (historical) | Pfizer | Finished-dose supplier with upstream API integration | Lidocaine injection products are part of historical large-scale sterile supply programs; upstream API procurement is standard for sterile injectables. |
| Akorn / Hikma / local equivalents (regional) | Various | Distributor or manufacturer (varies by geography) | In many regions, sterile injectables use local procurement models that trace back to API manufacturing partners. |
| Major Asian API manufacturers (common in tenders) | Multiple | API manufacturing | Lidocaine hydrochloride is widely produced by China- and India-based API makers that support regulated markets. |
Actionable takeaway: In practice, regulated-market supply is dominated by a small number of global API manufacturers plus multiple regional and trading intermediaries. Procurement teams typically start with DMF/EDMF holders for regulatory acceptance, then dual-source for commercial continuity.
Who supplies lidocaine hydrochloride as an intermediate or for drug substance manufacturing?
Lidocaine hydrochloride is synthesized from intermediates produced by specialty chemical suppliers. While many chemical companies do not advertise as “lidocaine hydrochloride API suppliers,” they support the manufacturing base via intermediates and specialty chemicals used in lidocaine production. For example, benzamide and diethylaminoethanol-type precursor chemistries are common industrial building blocks for anesthetic APIs.
Actionable takeaway: If you are assessing cost down or supply resilience, intermediary supplier mapping is often more effective than relying solely on public-facing “finished API” listings because intermediate availability determines batch throughput for API makers.
Where do pharmaceutical distributors source lidocaine hydrochloride?
Distributors generally do not produce lidocaine hydrochloride; they source it from API manufacturers and sometimes repack in local supply chains. Common distributor categories include:
- Global pharmaceutical distributors with multi-market regulatory workflows
- Regional wholesalers that stock injectable anesthetic materials
- API trading platforms that route inventory from manufacturers to local buyers
Actionable takeaway: Distributor sourcing accelerates procurement but can add traceability and lead-time complexity. For sterile injectables, buyers usually prefer manufacturers who can provide batch-level documentation and regulatory dossiers aligned to their target markets.
How to shortlist credible suppliers for regulated procurement
What documentation should suppliers provide?
For procurement-grade lidocaine hydrochloride, buyers typically require:
- Regulatory filings: DMF/EDMF status, or ability to support cross-referencing
- Quality systems: GMP compliance evidence (inspection outcomes and audit readiness)
- Batch documentation: CoA/CoC, impurity profile, residual solvents (where applicable)
- Analytical methods: specification + method transfer support
- Stability: shelf-life and storage conditions aligned to dosage form requirements
Actionable takeaway: The shortlist should be built on dossiers and audit readiness first, not commercial pricing alone, since lidocaine HCl is widely sourced and substitutions can fail at the documentation layer.
What are common specification and compliance constraints?
Lidocaine hydrochloride used in pharmaceuticals is usually governed by pharmacopeial specs (commonly USP/EP/BP) and customer-specific injectable tolerances. Procurement teams typically verify:
- Assay range and purity
- Specified impurities and limits
- Water content and related physical-chemical specs
- Residual solvents limits (if solvent crystallization or processing is used)
- Particle/physical form (important for downstream formulation performance)
Actionable takeaway: Suppliers that meet pharmacopeial and internal impurity limits will win repeat procurement. Those that “mostly meet” specs will be pushed out after first stability or release-rate issues.
Supplier mapping you can use immediately
What procurement strategy works best for lidocaine hydrochloride?
For business continuity and regulatory continuity:
- Pick 2 to 3 DMF/EDMF-aligned API manufacturers as primary suppliers.
- Add 1 distributor or alternate contract manufacturer for short-cycle replenishment.
- Require batch traceability aligned to your target dosage form (e.g., injectable parenteral quality documentation).
- Qualify by side-by-side comparability for impurity profile and performance in your formulation.
This approach fits how lidocaine hydrochloride is treated in regulated sourcing: broad availability exists, but dossier acceptance and batch comparability decide vendor retention.
Key Takeaways
- Lidocaine hydrochloride supply is dominated by global API manufacturers plus regional distributors that aggregate inventories.
- Shortlist suppliers by DMF/EDMF readiness, GMP/audit readiness, batch-level CoA documentation, and impurity/spec alignment, not by price alone.
- For continuity, run dual or triple sourcing across API makers and add a distributor/alternate contract channel for fill-in demand.
FAQs
-
Is lidocaine hydrochloride supplied primarily by API manufacturers or distributors?
API makers supply the substance; distributors typically aggregate and locally distribute inventory after sourcing from API producers. -
What determines whether an API supplier is acceptable for regulated manufacturing?
DMF/EDMF alignment (or cross-reference support), GMP inspection readiness, batch documentation quality, and impurity/spec conformance. -
Do suppliers for lidocaine hydrochloride differ by dosage form (injectable vs topical)?
The API suppliers can be the same, but injectable programs require stronger batch documentation, traceability, and controls tied to sterility assurance workflows. -
What is the fastest path to secure lidocaine HCl supply in volume?
Use a two-tier approach: primary qualification with API manufacturers, plus a secondary distributor/alternate channel for short-cycle replenishment. -
What quality attributes most often drive vendor switching in lidocaine hydrochloride programs?
Impurity profile consistency, CoA release alignment, residual solvent and water controls, and batch-to-batch comparability in downstream formulation.
References
[1] USP. United States Pharmacopeia and National Formulary (USP-NF): Lidocaine Hydrochloride monograph (latest edition).
[2] European Pharmacopoeia (Ph. Eur.). European Pharmacopoeia monograph for Lidocaine Hydrochloride (latest edition).
[3] World Health Organization. WHO Prequalification of Medicines Programme guidance (quality and regulatory dossier principles relevant to API sourcing).
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