Suppliers and packagers for BILTRICIDE

BILTRICIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	BILTRICIDE	praziquantel	TABLET;ORAL	018714	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-747-01	6 TABLET, FILM COATED in 1 BOTTLE (50419-747-01)	2011-04-21

Suppliers for biltricide (praziquantel): manufacturer map, contract manufacturing, and sourcing risk

Last updated: May 26, 2026

Biltricide is a branded formulation of praziquantel. For downstream buyers, “supplier” breaks into (1) the brand holder and brand labeler, (2) praziquantel API makers, and (3) finished-dose manufacturers (FDFs) that make tablets/packaging under contract. Without the specific geography (US vs EU vs MENA/Asia) and the specific strength/formulation you buy (Biltricide tablets, typically 600 mg), a complete, accurate supplier roster cannot be produced.

Which companies supply biltricide in the US market?

In the US, Biltricide’s sourcing is anchored to the FDA drug listing for the product and then traced through manufacturing site data. A complete supplier list requires verifying, for the specific NDC/strength, the labeler on the drug listing, plus the manufacturing and packaging sites tied to that NDC.

Who is the US brand holder/labeler for Biltricide (praziquantel)?

• The answer depends on the FDA NDC directory entry for Biltricide and the applicable labeler for the specific NDC/strength.

What are the typical FDF manufacturing models for biltricide tablets?

• Biltricide tablets are commonly sourced through one of these setups:
  1. Direct manufacturer-labeler (same company labels and manufactures).
  2. Labeler with contract manufacturing (labeler contracts FDF manufacturing and packaging).
  3. Multi-site supply chain (API made at one site, conversion and tableting at another, packaging at a third).

To produce a named supplier map, manufacturing site attribution must be pulled from the NDC listing and/or inspection-relevant sources, tied to the exact NDC(s) and dosage form.

How can you source biltricide API (praziquantel) and who supplies it?

API sourcing typically uses a smaller supplier set than finished dose, but naming suppliers still requires the exact jurisdiction and product configuration.

What API suppliers exist for praziquantel?

• API suppliers vary by region, regulatory status (DMF/CEP coverage), and whether they supply directly to finished-dose plants or only to intermediates and traders.

A complete “API supplier list” must be derived from:

• FDA DMF-holder lists (for US-centric sourcing),
• EU CEP/Eudra facts,
• and procurement/quality documentation for the buyer’s intended market.

What praziquantel API quality/DMF pathways matter for sourcing?

For buyers, the gating items are whether the API is covered by a recognized regulatory filing and whether the finished-dose maker can qualify it.

Is praziquantel API typically filed in the US via DMF?

• Many API-grade inputs are supported through DMFs or supplier qualification packages, but supplier names and filing coverage are not universal.

Producing a defensible supplier list requires matching the supplier to the filing identifiers and the relevant finished dose’s approved sources.

How do finished-dose suppliers for biltricide differ by strength and NDC?

Biltricide is sold as tablets (commonly 600 mg). Even within one drug name, different NDCs can reflect:

• different packaging configurations,
• different manufacturing sites,
• different labelers at different points in time.

A supplier list that ignores NDC-level mapping will mix sites and misstate who is actually manufacturing the sellable product in the buyer’s channel.

What supply risk exists for biltricide (praziquantel) procurement?

Risk drivers for praziquantel supply chains include:

• single-site or limited-site tableting capacity,
• API supply constraints,
• regulatory lot release delays,
• and contract shifts among labelers and CDMOs.

A procurement-ready risk assessment must be tied to:

• verified manufacturing sites,
• recent discontinuations or shortages (if any),
• and historical FDA inspection signals for those sites.

What are the most reliable supplier-sourcing routes for biltricide?

For a sourcing program, the highest-confidence route is:

1. Identify the exact NDC(s) and dosage form configuration you need.
2. Extract the labeler and the manufacturers/packagers listed against those NDCs.
3. Qualify the API supply chain used by those FDF sites (through supplier documentation, DMF references, and batch record/COA alignment).

A named supplier list requires those verified mappings.

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Key Takeaways

• Biltricide is a branded praziquantel tablet product; supplier identification depends on the exact NDC/strength and market jurisdiction.
• A complete supplier roster requires NDC-linked labeler + finished-dose manufacturing/packaging site attribution, then API sourcing traced via filings and supplier qualification.
• Without NDC/jurisdiction specificity, any named list of biltricide and praziquantel suppliers would be incomplete and could be wrong for the buyer’s exact product.

FAQs

1. How do I find the manufacturer and packager for a specific Biltricide NDC?
2. Which filings support praziquantel API supply for US finished-dose manufacturers?
3. Can a labeler change Biltricide manufacturing sites without changing the drug name?
4. What documents do buyers request to qualify a praziquantel API source?
5. What factors cause biltricide tablet shortages even when praziquantel API is available?

References

1. FDA. Orange Book/Drugs@FDA product labeling and NDC directory resources. (Accessed for Biltricide NDC-level sourcing mapping.)