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Suppliers and packagers for generic pharmaceutical drug: 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
Suppliers for the Pharmaceutical Drug: Praziquantel
Introduction
Praziquantel is a broad-spectrum anthelmintic agent primarily used in the treatment of parasitic infections, notably schistosomiasis and various fluke infections. Recognized by its efficacy and safety profile, praziquantel remains a cornerstone in parasitic disease management, especially in endemic regions. Its global demand has prompted a diverse array of suppliers spanning pharmaceutical manufacturers, generic producers, and regional distributors. This report examines the key suppliers, their manufacturing capabilities, market shares, and strategic positioning within the pharmaceutical supply chain for praziquantel.
Market Overview
Praziquantel, chemically known as 54-phenylthiazolidin-2,4-dione, was first synthesized in the 1970s and has since been incorporated into essential medicines lists by organizations like the WHO. The drug is classified as a WHO essential medicine, underlining its importance in global health. The industry has seen consistent growth due to increasing parasitic disease prevalence in developing regions, rising awareness, and expanding pharmaceutical infrastructure.
The demand for praziquantel is influenced by public health campaigns, endemic region needs, patent statuses, and the proliferation of generic formulations. While original branded versions, such as those produced by Merck KGaA (Eisai's original partner), historically dominated, the market landscape has evolved toward diverse regional and generic manufacturers.
Major Suppliers of Praziquantel
1. Merck KGaA (Eisai Licensee and Original Innovator)
Merck KGaA, through its prior licensing agreements, was one of the first companies to commercialize praziquantel. Though patent expiration has allowed for generic manufacturing, Merck continues to produce a high-quality, branded formulation mainly for specific markets. Its reputation as a quality-assured supplier supports its continued relevance in regions where brand trust influences procurement.
2. Sichuan Kelun Pharmaceutical Co., Ltd.
A leading Chinese pharmaceutical company, Sichuan Kelun Pharmaceutical, is a prominent producer of praziquantel. It offers both WHO-prequalified bulk API (Active Pharmaceutical Ingredient) and finished dosage forms. Kelun's manufacturing facilities adhere to Good Manufacturing Practices (GMP), and it has established extensive distribution channels primarily across Asia and Africa.
3. Ajanta Pharma Ltd.
An Indian multinational specializing in generic pharmaceuticals, Ajanta Pharma supplies praziquantel in various formulations, including tablets used in schistosomiasis treatment. Ajanta benefit from India’s status as a hub for generic drug production, with GMP compliance and strategic distribution networks covering Africa, Southeast Asia, and Latin America.
4. Hetero Drugs Ltd.
Hetero is an Indian-based pharmaceutical giant with significant capabilities in the production of antiparasitic agents, including praziquantel. Their facilities conform to global standards, and they export to over 100 countries. Hetero's competitive pricing and robust supply chain make it a key player in the praziquantel market.
5. Yung Shin Pharmaceutical Industries
Based in Taiwan, Yung Shin specializes in manufacturing a wide range of anthelmintic drugs, including praziquantel. It supplies both API and finished formulations, primarily targeting Asian and Middle Eastern markets. The company emphasizes quality compliance through certifications like GMP and ISO.
6. Other Notable Players
Additional suppliers include:
- Macleods Pharmaceuticals (India): Offering competitive pricing and broad distribution.
- Zhejiang Medco Health Industry Co. (China): Focused on bulk API sales.
- Jiangsu Hengrui Medicine Co. (China): Expanding into antiparasitic pharmaceuticals.
Manufacturing Capabilities and Quality Standards
Most key suppliers operate manufacturing facilities compliant with international standards such as GMP, ISO, and WHO PQ (Prequalification). The API production process involves synthesis from 4-phenyl-1,2,4-triazol-3-one derivatives, followed by stringent purification. Finished forms include 600 mg tablets, often produced at facilities with capacity ranging from several hundred kilograms to multiple metric tonnes per annum, ensuring global supply sufficiency.
Regional Distribution and Market Dynamics
Developing countries, particularly in Africa, Southeast Asia, and Latin America, dominate praziquantel consumption, driven by endemicity and public health initiatives. Suppliers like Kelun, Hetero, and Ajanta have structured their supply chains to prioritize these regions, often providing low-cost generic formulations under local procurement schemes.
Regulatory approvals, such as WHO prequalification and adherence to international pharmacovigilance standards, influence supplier credibility. For example, Kelun's WHO PQ-certified API enhances its attractiveness for procurement by UNICEF and WHO procurement agencies.
Challenges and Opportunities
Supply Chain Disruptions: Dependence on API suppliers from China and India exposes markets to geopolitical risks and manufacturing disruptions. Establishing diversified manufacturing bases and increasing API stockpiles can mitigate shortages.
Regulatory Barriers: Variance in regulatory requirements across countries complicates market entry. Suppliers investing in compliance documentation and quality assurance benefit from better acceptance and institutional tenders.
Market Expansion: Opportunities exist for expanding supply to non-endemic regions via growing awareness and increasing parasitic disease surveillance. Strategic partnerships with NGOs and government agencies facilitate market penetration.
Conclusion
The global praziquantel supply chain is characterized by a blend of historic innovators and aggressive generic manufacturers, primarily concentrated in China and India. Continuous capacity expansion, adherence to international standards, and strategic regional focus underpin the competitive landscape. Ensuring reliable procurement, quality assurance, and regulatory compliance remains central to maintaining a stable supply of this essential medicine.
Key Takeaways
- The praziquantel market is led by regional generic manufacturers including Sichuan Kelun, Hetero Drugs, Ajanta Pharma, and Yung Shin Pharma.
- WHO prequalification and GMP compliance are critical for supplier credibility and access to major global procurement programs.
- Diversification of manufacturing sources minimizes supply risks associated with geopolitical or production disruptions.
- Growing endemic regions necessitate scalable production capacities and strategic distribution networks.
- Regulatory harmonization and continued quality improvements are essential for expanding market share and ensuring drug efficacy and safety.
FAQs
1. Who are the leading global suppliers of praziquantel?
Major manufacturers include Sichuan Kelun Pharmaceutical, Hetero Drugs, Ajanta Pharma, and Yung Shin Pharmaceutical Industries, each with global distribution and GMP-compliant facilities.
2. What are the key quality standards to look for in praziquantel suppliers?
Suppliers should meet GMP standards, possess WHO prequalification, and have ISO certifications to ensure consistent drug quality and safety.
3. How does patent status affect praziquantel supply?
Since patent protections expired decades ago, generic manufacturers predominantly supply praziquantel, expanding access while increasing market competition and reducing prices.
4. What regions are the primary consumers of praziquantel?
Endemic regions in Africa, Southeast Asia, and Latin America are the main consumers, supported by public health initiatives and international aid programs.
5. What future trends could influence praziquantel supply?
Expanded manufacturing capacity, regional API production, regulatory harmonization, and increasing parasitic disease prevalence could significantly impact the supply landscape.
References
- World Health Organization. (2022). Guidelines for the Treatment of Parasitic Infections.
- Market data from GlobalData Pharma Intelligence. (2023). Praziquantel Market Analysis.
- Company websites and public filings of Sichuan Kelun, Hetero, Ajanta Pharma, and Yung Shin Pharma.
- WHO Prequalification Programme. (2023). List of PQ-certified praziquantel manufacturers.
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