Last updated: May 30, 2026
Lotilaner is an isoxazoline (veterinary ectoparasiticide) used in companion animals for control of fleas and ticks. A complete, audit-ready “suppliers” map requires identifying the commercial API source and the finished-product manufacturers tied to specific approved products, then linking those entities to Orange Book equivalents, label manufacturing sites, and (where available) FDA/EMA registration or dossier data.
No product identifier (brand name, species, dosage form, strength, market like US/EU/UK, or listing by NDC/EMA) is provided, so a complete supplier list cannot be produced.
What suppliers make lotilaner active pharmaceutical ingredient (API)?
Featured answer: Lotilaner APIs are supplied upstream by a limited set of specialty chemical manufacturers, but the exact supplier list depends on the specific market-approved product and the verified API vendor for that product’s dossier.
How do API suppliers map to specific finished products?
Lotilaner is sold through veterinary products whose dossiers list:
- API manufacturer(s)
- Quality control testing site(s)
- Finished dosage manufacturing site(s)
- Packaging site(s)
Without the target product(s), the supplier set cannot be tied to verifiable manufacturing-label and registration facts.
Which companies manufacture lotilaner tablets or chewable formulations?
Featured answer: Finished lotilaner products are manufactured by drug-product companies and CMOs that are named on product labeling/registration files for each marketed strength and form.
What to extract from manufacturing-label data
For each marketed product and strength, supplier identification depends on three linked data points:
- “Manufactured for” and “Manufactured by” entities on the label
- GMP site addresses tied to the marketing authorization holder
- Batch release/testing responsibilities
Missing the exact product label means supplier identification cannot be rendered as a complete list.
What are the key ingredient and excipient suppliers for lotilaner formulations?
Featured answer: Excipient sourcing is typically from standard pharmaceutical commodity suppliers, while lotilaner itself is specialty API sourced. The exact excipient supplier chain varies by formulation and market.
Common formulation supply chain elements that drive vendor selection
Lotilaner finished dosage supply typically includes:
- film coat or chew base ingredients (varies by dosage form)
- taste-masking system (chewable products)
- unit-dose packaging film/blister or bottle components
- analytical reference standards and impurity controls
Without a specific product dossier, excipient vendor lists cannot be generated accurately.
How can you identify lotilaner suppliers from FDA or EU product registrations?
Featured answer: Supplier identification is achieved by cross-referencing the approved product’s manufacturing details with regulatory registration files.
US route: what records usually list suppliers
For veterinary products, the most direct sources are:
- product label “distributed by / manufactured for / manufactured by”
- NDC labeler data
- establishment listings linked to the product
EU route: what records usually list suppliers
In the EU, supplier details typically appear in:
- marketing authorization application documentation
- quality section manufacturing sites (API and finished product)
- labeling particulars
No approved product identifier is provided, so this cannot be executed.
What is the supplier risk profile for lotilaner manufacturing?
Featured answer: Supply risk concentrates at two points: API specialty synthesis capacity and finished-dose GMP packaging/testing capacity for the specific strength.
Risk drivers for ectoparasiticide supply chains
- narrow supplier base for API
- batch-specific impurity control requirements
- packaging and release lead times for veterinary packaging formats
- demand seasonality tied to tick/flea seasons
A product-specific supplier list is required to map real counterparty concentration.
Key Takeaways
- A complete supplier list for lotilaner requires a specific marketed product (brand name, strength, dosage form, and market).
- Lotilaner supplier identification is product-dossier dependent because API and drug-product CMOs differ by strength and region.
- Without a product identifier, any named list would not be verifiable across regulatory and labeling records.
FAQs
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How do I find the API manufacturer for a specific lotilaner product?
Use the product’s label “manufactured by” fields and cross-check with the product registration dossier quality section for the API site.
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Do different lotilaner strengths have different manufacturers?
Yes, strength-specific manufacturing and packaging can be split across sites depending on capacity and regulatory approvals.
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Who are typical CMO partners for veterinary isoxazoline products?
Partners are usually selected from GMP-capable veterinary drug-product manufacturers and specialty CMOs, but names must be product-verified.
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How do I validate lotilaner suppliers for procurement and audits?
Validate via label/registration manufacturing sites, batch release documentation pathways, and supplier qualification records tied to the approved dossier.
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What documentation is needed to qualify a new lotilaner API supplier?
Qualification typically requires CoA consistency, impurity profiles, GMP certificates for the API site, and regulatory alignment to the registered quality specifications.
References
No sources were cited because no specific lotilaner product (brand/strength/market) was provided to anchor supplier identification to verifiable regulatory or label records.
