Last Updated: June 25, 2026

Suppliers and packagers for generic pharmaceutical drug: PERMETHRIN


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PERMETHRIN

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Aurobindo Pharma Usa ELIMITE permethrin CREAM;TOPICAL 019855 NDA Aurobindo Pharma Limited 59651-834-60 1 TUBE in 1 CARTON (59651-834-60) / 60 g in 1 TUBE 2024-01-22
Aurobindo Pharma Usa ELIMITE permethrin CREAM;TOPICAL 019855 NDA AUTHORIZED GENERIC Aurobindo Pharma Limited 84386-073-60 1 TUBE in 1 CARTON (84386-073-60) / 60 g in 1 TUBE 2024-01-22
Actavis Labs PERMETHRIN permethrin CREAM;TOPICAL 074806 ANDA Actavis Pharma, Inc. 0472-0242-60 1 TUBE in 1 CARTON (0472-0242-60) / 60 g in 1 TUBE 2004-11-30
Encube Ethicals PERMETHRIN permethrin CREAM;TOPICAL 211303 ANDA Encube Ethicals, Inc. 21922-021-07 1 TUBE in 1 CARTON (21922-021-07) / 60 g in 1 TUBE 2019-04-08
Encube Ethicals PERMETHRIN permethrin CREAM;TOPICAL 211303 ANDA A-S Medication Solutions 50090-5888-0 1 TUBE in 1 CARTON (50090-5888-0) / 60 g in 1 TUBE 2019-04-08
Encube Ethicals PERMETHRIN permethrin CREAM;TOPICAL 211303 ANDA Preferred Pharmaceuticals Inc. 68788-8439-6 1 TUBE in 1 CARTON (68788-8439-6) / 60 g in 1 TUBE 2023-06-05
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Permethrin suppliers: how to identify manufacturers, API/finished-dose sources, and supply-chain alternatives

Last updated: May 26, 2026

Permethrin is a pyrethroid insecticide used in human and veterinary topical products. Supplier landscapes differ sharply by whether you need active pharmaceutical ingredient (API), finished-dose formulations (e.g., cream/solution), or intermediates. Market entry is constrained by regulatory registration, manufacturing capacity, and the need to match the isomer profile and specifications for the target product (human scabies/lice therapies vs veterinary insecticides).

What companies supply permethrin API and permethrin intermediates?

Short answer: Global chemical and agrochemical manufacturers dominate permethrin supply for specialty chemicals, while pharmaceutical finished-dose products typically come from a mix of branded-generic producers and local formulation licensees. The API supply base is concentrated, and alternative sourcing depends on isomer purity, compliance history, and the ability to support controlled shipments for regulated end uses.

Typical supplier categories in permethrin sourcing

  1. Pyrethroid-grade chemical manufacturers (API and intermediates)
    • Produce permethrin isomer mixtures or specific isomer blends depending on end market specs.
  2. Finished-dose pharmaceutical formulators
    • Produce cream, lotion, or solution at dosage-strength spec for scabies, pediculosis, and other dermal indications.
  3. Contract manufacturing organizations (CMOs)
    • Formulate and pack under customer labels for markets that require local registration.
  4. Distributor networks and brokers
    • Fill gaps on lead times and regional compliance, but add friction for qualification and change-control.

API vs formulation: sourcing implications

  • API qualification: requires COA alignment (impurities, isomer distribution, water content where relevant), GMP documentation, and change history.
  • Formulation qualification: requires bridging data for content uniformity, stability, preservative compatibility (if used), and packaging/closure system.

Which manufacturers make finished-dose permethrin creams and lotions?

Short answer: Permethrin finished products are usually supplied by branded holders and generic manufacturers that have established formulation and distribution channels in specific regions. Finished-dose sourcing is more dependent on local approvals (FDA/EMA national registrations) than on global API price.

Common finished-dose product forms for human use

  • Permethrin cream (scabies)
  • Permethrin lotion/solution (pediculosis)
  • Permethrin veterinary topical preparations (varies by country)

How to map finished-dose suppliers by geography

Finished-dose procurement is best structured as:

  • United States: suppliers listed on FDA labeling and commercial distribution; manufacturers and labelers tied to NDCs.
  • EU/UK: marketing authorisation holders and local relabelers.
  • APAC/LatAm/MENA: local registrations may be supplied by CMOs with licensing.

How do you find permethrin suppliers in the Orange Book and FDA label ecosystem?

Short answer: Permethrin is often handled as a dermatologic drug with topical OTC or prescription pathways in some markets; supplier identification in the U.S. typically uses NDC labeler/manufacturer data plus FDA labeling records rather than relying on an Orange Book patent-only view.

Practical procurement mapping approach for regulated markets

  • Start with NDC labeler and manufacturer/distributor fields on product databases.
  • Cross-check with FDA labeling and package insert manufacturer statements.
  • Validate GMP status through facility documentation (DMF/inspection history where applicable).

What regulatory constraints affect permethrin supplier eligibility?

Short answer: Regulatory eligibility hinges on GMP manufacturing, quality system controls, impurity profile, and correct specification to the intended dosage form. For topical insecticide products used in human care, regulators scrutinize consistency and stability.

Quality and compliance points buyers typically enforce

  • GMP manufacturing for API and finished product
  • Specification packages for:
    • active content assay
    • key impurities
    • residual solvents (if relevant)
    • isomer profile (where specified)
    • physical specs (viscosity for lotions/solutions, microbiological limits where relevant)
  • Stability evidence covering intended shelf life
  • Packaging system qualification to prevent degradation or content drift

What are the biggest supply-chain risks for permethrin sourcing?

Short answer: The biggest procurement risks are capacity concentration in pyrethroid chemistry, lead-time variability, and specification mismatch between isomeric grades. Finished-dose supply is additionally exposed to packaging constraints and regional registration bottlenecks.

Risk factors buyers screen

  • Isomer profile mismatch: product performance can fail if the wrong blend is used relative to target specifications.
  • Impurity drift across batches: requires robust change control and ongoing COA trend review.
  • Raw material price swings: pyrethroid feedstocks can move with agrochemical cycles.
  • Regulatory and registration delays: can block alternate finished-dose suppliers.

How does permethrin API supply compare with alternative pyrethroids?

Short answer: Permethrin competes with other pyrethroids (e.g., pyrethrins/pyrethroids in lice/scabies and veterinary insecticide uses). Substitution is constrained by formulation performance and regulatory/label claims.

Substitution analysis buyers typically run

  • efficacy equivalence under labeled-use conditions
  • compatibility with topical vehicles
  • patient acceptability (greasiness, odor, wash-off)
  • stability and degradation pathways in the formulation

What generic entry risks exist for permethrin products?

Short answer: Generic entry risk is typically operational rather than patent-driven, because permethrin is a long-established active ingredient in many markets. The main barrier tends to be formulation registration, quality system validation, and supply continuity rather than inventiveness.

Operational barriers that affect generic timing

  • lead times for qualified API grade
  • stability and clinical-bridging requirements when formulation differs
  • packaging and container-closure qualification timelines

Where can you source permethrin when supply is constrained?

Short answer: In constrained periods, buyers typically expand sourcing across:

  1. alternative API grades that meet the same spec package
  2. alternative formulation packers/CMOs
  3. regional finished-dose licensees with established registration

Qualification pathway for alternate suppliers

  • APQR/COA review for initial lot acceptance
  • accelerated stability testing for the specific formulation
  • comparability testing on key physical and chemical parameters
  • packaging system evaluation under temperature/light stress

Key Takeaways

  • Permethrin sourcing splits into API, intermediates, and finished-dose supplies; each has different supplier ecosystems and qualification burdens.
  • Supplier eligibility is driven by GMP, spec alignment (including isomer profile where specified), and stability/packaging qualification.
  • Supply-chain risk clusters around pyrethroid capacity concentration, lead-time volatility, and spec drift.
  • In regulated markets, identifying suppliers is best done through NDC labeler/manufacturer mapping and confirmed labeling/registration records rather than relying on patent registers alone.

FAQs

1) Can I source permethrin from agrochemical-grade suppliers for pharmaceutical use?
Only if the supplier’s grade meets the target pharma specification package (impurities, isomer profile, residuals) and is supported by GMP documentation and validation evidence.

2) What matters most for permethrin isomer profile when choosing an API supplier?
The isomer distribution must match the specification linked to the intended product performance and regulatory registration.

3) How do I qualify a new permethrin API supplier quickly?
Use a structured incoming QA approach: COA/spec matching, impurity trend review, initial lot release testing, then stability and process capability evaluation under the customer’s existing formulation parameters.

4) Are contract manufacturers common for permethrin topical products?
Yes, especially for packaging and local-market supply, but qualification still requires bridging and stability evidence for the specific formulation and container-closure system.

5) What are typical lead-time drivers for permethrin finished-dose supply?
API lead times, regulatory release documentation, bulk-to-finish scheduling, stability program timelines, and packaging material availability.

References

  1. U.S. Food and Drug Administration. (n.d.). Drug databases and labeling resources (NDC and product label information). FDA. https://www.fda.gov/
  2. European Medicines Agency. (n.d.). Medicines regulatory information and public assessment sources. EMA. https://www.ema.europa.eu/
  3. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

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