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 the Pharmaceutical Drug: BILTRICIDE

Last updated: July 30, 2025

Introduction

BILTRICIDE, the brand name for the oral formulation of thiabendazole, is an anthelmintic medication primarily used for treating parasitic worm infections. It has historically been employed to combat various nematodal infestations, including strongyloidiasis and roundworm infections. Although its prominence has diminished with the advent of newer antiparasitic agents, BILTRICIDE remains available in certain markets and formulations, making its supply chain relevant for healthcare providers, pharmacies, and pharmaceutical distributors. This comprehensive analysis provides insights into key suppliers, manufacturing sources, and the procurement landscape for BILTRICIDE.

Manufacturing Origin and Global Suppliers

Historical and Current Manufacturing Sites

BILTRICIDE’s active pharmaceutical ingredient (API), thiabendazole, is synthesized primarily in facilities based in Europe and Asia. The original formulations were produced by GlaxoSmithKline (GSK), which marketed BILTRICIDE under various regional brand names. With patent expiry and market shifts, manufacturing has increasingly diversified, involving generic pharmaceutical companies that produce both API and finished dosage forms.

Leading Suppliers and Manufacturers

1. GlaxoSmithKline (GSK)

• Role: Historically, GSK served as the primary manufacturer for BILTRICIDE in various markets.
• Current Status: While GSK discontinued some formulations, its legacy manufacturing plants once supplied early BILTRICIDE products. In certain markets, GSK still supplies API or finished products under older contractual arrangements.

2. Mylan (Now part of Viatris)

• API Production: Mylan has been a significant producer of thiabendazole APIs, supplying generic formulations of BILTRICIDE worldwide.
• Distribution: As a global generic pharmaceutical company, Mylan's manufacturing facilities in India, Europe, and North America have supplied finished dosage forms.

3. Intas Pharmaceuticals

• Market Presence: Based in India, Intas manufactures thiabendazole API and generic BILTRICIDE formulations for domestic and export markets.
• Regulatory Compliance: Their products are registered with agencies such as the Indian Central Drugs Standard Control Organization (CDSCO) and are often exported under various brand names.

4. Zhejiang Hisun Pharmaceuticals

• API Suppliers: As a Chinese pharmaceutical conglomerate, Hisun produces thiabendazole API for both domestic Chinese markets and export.
• Product Range: Their portfolio includes antiparasitic agents, including formulations similar to BILTRICIDE.

5. Other Generics Manufacturers

Numerous smaller pharmaceutical companies and contract manufacturing organizations (CMOs) in India, Turkey, and Eastern Europe produce thiabendazole APIs and finished drugs. Notable mentions include:

• Zhejiang Tianyu Pharmaceutical Co.
• Hetero Labs (India)
• Synthon (in some European markets)

Supply Chain Dynamics

The API market for thiabendazole is characterized by high fragmentation, with multiple producers across Asia and Europe. Finished pharmaceutical formulations often depend on regional regulatory approvals and market demand, creating variation in availability.

Procurement Considerations for BILTRICIDE

Regulatory Approvals and Quality Standards

Suppliers must adhere to Good Manufacturing Practices (GMP) to ensure the safety and efficacy of finished products. Regulatory agencies like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and India's Central Drugs Standard Control Organization (CDSCO) validate manufacturers’ compliance before approving imports or local production.

Supply Chain Risks

Disruptions may originate from manufacturing delays, regulatory hurdles, geopolitical factors, or supply chain bottlenecks, especially in API sourcing from Asia. Diversification of suppliers and manufacturing sites mitigates these risks.

Market Availability

Although BILTRICIDE is not as widely used as newer antiparasitic agents like albendazole or ivermectin, niche markets, endemic regions, and retired formulations maintain a consistent, albeit limited, supply chain.

Major Suppliers and Distributors in the Market

Supplier / Manufacturer	Role	Region	Product Focus	Regulatory Status
GlaxoSmithKline (GSK)	Original manufacturer	Global	BILTRICIDE formulations	Market-dependent (some regions discontinued)
Viatris (formerly Mylan)	API and generics	Global	Thiabendazole-based drugs	Approved in key markets
Intas Pharmaceuticals	API producer, generics	India, export	Thiabendazole formulations	CDSCO approved
Zhejiang Hisun Pharmaceuticals	API and formulations	China	Thiabendazole products	NMPA approved
Hetero Labs	API and generics	India	Thiabendazole-based drugs	DCGI approval

Distribution Channels

• Pharmaceutical Wholesalers: Major distributors supply hospitals, clinics, and pharmacies with licensed products.
• Importers and Exporters: Companies specializing in niche antiparasitic products facilitate cross-border procurement.
• Online and Catalog Distributors: Limited, due to regulatory constraints and the specialized nature of the drug.

Future Outlook

The demand for BILTRICIDE is expected to remain stable in regions where parasitic infections are endemic or where resistance to other drugs is emerging. However, market shifts favor newer, broader-spectrum antiparasitics, potentially affecting supplier dynamics and pricing.

Emerging markets and private label manufacturers may expand supply chains, especially if patent protections expire or if regulatory pathways simplify registration processes for generic versions. Supply chain resilience will depend on API production capacity, geopolitical stability, and adherence to quality standards.

Key Takeaways

• Diverse Supplier Base: The API for BILTRICIDE (thiabendazole) is produced primarily by companies in India and China, with established players like Intas and Zhejiang Hisun leading in API manufacturing.
• Market Trends: While original manufacturers like GSK have diminished their role, generics producers continue to supply BILTRICIDE formulations, maintaining availability across different markets.
• Regulatory Considerations: Procurement must prioritize suppliers compliant with GMP and holding necessary regulatory approvals to mitigate quality and safety risks.
• Supply Chain Risks: Fragmentation and geopolitical factors pose risks; diversification and strategic sourcing are advisable for reliable supply.
• Demand Dynamics: Limited but steady demand in specific regions will sustain the supply chain for BILTRICIDE, though newer antiparasitic agents may impact long-term market share.

FAQs

1. Who are the primary global suppliers of the API for BILTRICIDE?
Major API suppliers include Intas Pharmaceuticals (India), Zhejiang Hisun Pharmaceuticals (China), and Hetero Labs (India). These companies produce thiabendazole API for regional and export markets, often supplying generic formulations of BILTRICIDE.

2. Is GSK still manufacturing BILTRICIDE?
GSK’s production of BILTRICIDE formulations has declined or ceased in certain regions due to market shifts and patent expirations. However, legacy products may still be available in select markets, and GSK's API manufacturing facilities historically contributed to supply.

3. What regulatory standards must suppliers meet for BILTRICIDE?
Suppliers must comply with GMP requirements and have approvals from relevant authorities, such as the FDA, EMA, CDSCO, or NMPA, depending on the market.

4. How does supply chain disruption affect BILTRICIDE availability?
Disruptions in API manufacturing, geopolitical issues, or regulatory delays can impact the availability of finished formulations. Diversifying suppliers and maintaining stockpiles mitigate these risks.

5. Are there alternatives to BILTRICIDE in parasitic infection treatment?
Yes. Alternatives include albendazole, ivermectin, mebendazole, and praziquantel. The choice depends on the specific parasite, region, and resistance patterns.

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References
[1] WHO Model List of Essential Medicines, 22nd List, 2021.
[2] US FDA Drug Database, 2023.
[3] Indian Central Drugs Standard Control Organization (CDSCO) Approved Drugs Database, 2023.
[4] European Medicines Agency (EMA). Product Information for Thiabendazole, 2022.
[5] Industry Reports on Antiparasitic Agents, 2022.