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Suppliers and packagers for praziquantel
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praziquantel
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ph Health | PRAZIQUANTEL | praziquantel | TABLET;ORAL | 208820 | ANDA | Endo USA, Inc. | 49884-231-83 | 6 TABLET, FILM COATED in 1 BOTTLE (49884-231-83) | 2017-11-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Praziquantel: Supplier Landscape for Drug Substance and Finished Dosage
What suppliers manufacture praziquantel drug substance (API)?
Global supply of praziquantel API is dominated by a small set of China- and India-based manufacturers with export programs. Commonly encountered suppliers in procurement and tender ecosystems include:
- China
- Hubei Xingfa Pharmaceutical Co., Ltd. (API manufacturer; praziquantel is produced for global markets)
- Hainan Haiyao Pharmaceutical Co., Ltd. (API manufacturer; praziquantel appears in product listings/export catalogues)
- Tianjin Pharmaceutical International Corporation (commercial channel; often listed in export documentation where supported by API producers)
- India
- Hetero Drugs Limited (API and/or finished dosage supply chain for praziquantel)
- MacLeods Pharmaceuticals Ltd. (API/finished supply in certain markets; praziquantel appears in historical tender catalogs)
These suppliers are repeatedly referenced across drug export listings and procurement databases used by ministries of health and distributors for praziquantel procurement. Public registries for exact manufacturing site attribution to each supplier name vary by country and tender.
What suppliers provide praziquantel finished dosage (tablets) for procurement?
Finished dosage supply for praziquantel is typically provided by generic manufacturers with direct tenders to public sector buyers (endemic disease programs) or through regional distributors. Commonly encountered suppliers include:
- WHO prequalification and global tendering ecosystem
- STADA (brands and generic supply in endemic program channels)
- Amneal Pharmaceuticals (generic supply presence in multiple anti-parasitics)
- Mylan / Viatris (generic supply programs in certain geographies)
- Regional generic manufacturers
- China-based finished dosage suppliers referenced through distributor procurement catalogs
- India-based finished dosage suppliers referenced through public tender rosters
Finished dosage procurement lists are often country-specific, and supplier identity can change by tender due to local licensing and batch availability.
What market channels are used to source praziquantel?
Praziquantel procurement typically runs through four pathways:
- Direct tender to finished-dosage manufacturers (public health procurement)
- Distributor import contracts (tenders that award to licensed importers)
- NGO procurement pipelines (endemic disease supply chains; batches routed through selected distributors)
- API-to-finished conversion (local formulators producing tablets under licensing where allowed)
Which quality and regulatory frameworks govern supplier selection?
Supplier selection for praziquantel is driven by compliance with requirements that vary by buyer, including:
- WHO recommended product / prequalification status (where applicable)
- GMP certification aligned to the buyer’s regulator
- Stable drug supply (long lead times for API and tablet filling)
For reference, praziquantel is cataloged in global medicinal product indexes and is included in procurement ecosystems used by health programs, which require batch-level documentation and quality controls. The WHO Model List of Essential Medicines includes praziquantel as an essential medicine used in schistosomiasis treatment (WHO EMList). [1]
What are practical supplier decision points for buyers?
1) Finished dosage vs API sourcing
- Finished tablets: faster access for endemic program delivery; requires batch release and labeling compliance.
- API sourcing: longer qualification cycle; used when a local tablet manufacturer is already licensed and has validated processes.
2) Form factor and strength
Most tenders target oral tablets of praziquantel, with strength and packaging defined by local procurement specifications. Differences in tablet strength (mg per tablet) and pack size can affect award eligibility.
3) Documentation package
Typical buyer requirements include:
- Certificate of Analysis (CoA) per batch
- GMP evidence for manufacturing sites
- Stability data summaries
- Evidence of regulatory authorization in the destination country (where required)
What countries and buyer ecosystems most often drive praziquantel sourcing?
Praziquantel demand is concentrated in endemic regions where schistosomiasis control is implemented, including sub-Saharan Africa and parts of Latin America and Asia. Procurement is often executed through:
- Ministry of Health tendering
- National control programs supported by international health agencies
- NGO-delivered supply chains
This demand pattern determines which suppliers are repeatedly present in the shortlists for public procurement.
Key Takeaways
- Praziquantel supply is concentrated among a limited set of API manufacturers (commonly China- and India-based) and a broader set of finished dosage suppliers that win tenders via regional distribution.
- Supplier selection is governed by batch documentation, GMP alignment, and (for many buyers) WHO-linked quality pathways.
- Procurement outcomes depend on whether the buyer orders finished tablets or API and on tender-specific form and packaging requirements.
FAQs
1) Can I source praziquantel as API only?
Yes. API sourcing is standard in markets where local manufacturers produce tablets under validated GMP processes, but qualification and documentation requirements are usually stricter than for finished-dosage procurement.
2) What typical buyer requirement blocks non-compliant suppliers?
Failure to provide batch-level CoA with identity/purity results, incomplete GMP evidence for the exact manufacturing site, or inability to meet destination-country authorization or labeling rules.
3) Are WHO-prequalified suppliers always the lowest-cost option?
Not always. In many public tender systems, lowest-cost is balanced against regulatory acceptance, lead time, and documentation completeness. Prequalification status often shortens qualification time.
4) Which supply route is faster for public health programs?
Finished dosage procurement is faster than API-to-tablet conversion because tablet formulation, packaging, and labeling are already validated and release-tested.
5) Why do supplier names change from one tender to the next?
Batch availability, local licensing, distributor eligibility, and tender-specific technical compliance drive award outcomes, even when the underlying manufacturing capacity comes from a recurring group of producers.
References
[1] World Health Organization. WHO Model List of Essential Medicines (praziquantel entry). World Health Organization. (Accessed via WHO Essential Medicines listings).
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