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Suppliers and packagers for generic pharmaceutical drug: TRICLABENDAZOLE
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TRICLABENDAZOLE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novartis | EGATEN | triclabendazole | TABLET;ORAL | 208711 | NDA | Novartis Pharmaceuticals Corporation | 0078-0937-91 | 4 TABLET in 1 BLISTER PACK (0078-0937-91) | 2019-02-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TRICLABENDAZOLE
Introduction
Triclabendazole is a benzimidazole derivative primarily employed in veterinary medicine for controlling Fasciola hepatica and Fasciola gigantica infections in livestock. It is also used off-label in some human parasitic infections, notably fascioliasis, although regulatory approvals vary globally. Given its significance in both agriculture and potential human health applications, understanding the supply chain and key suppliers of Triclabendazole is critical for pharmaceutical companies, distributors, and healthcare providers planning procurement strategies.
This article offers a comprehensive overview of the main suppliers of Triclabendazole, examining global manufacturing landscapes, regulatory considerations, and market dynamics. It aims to inform stakeholders on sourcing options, supplier reliability, and regulatory compliance.
Global Manufacturing Landscape
Triclabendazole is a specialized pharmaceutical compound with production concentrated primarily in regions with robust pharmaceutical manufacturing capabilities, notably China and India. These countries host major generic and active pharmaceutical ingredient (API) manufacturers capable of producing Triclabendazole at scale.
Chinese Suppliers
China dominates the Triclabendazole supply chain, with several chemical manufacturers producing both the API and finished formulations. Chinese firms benefit from lower production costs, established export infrastructure, and favorable regulatory environments, enabling them to supply markets worldwide.
- Sino An Pharmaceutical Co., Ltd.: Recognized for producing a broad range of antiparasitic APIs, Sino An supplies Triclabendazole to international markets, adhering to GMP standards.
- Shandong Xinhua Pharmaceutical Co., Ltd.: A leading API manufacturer with export licenses for veterinary pharmaceuticals, including Triclabendazole.
- Hubei Kanghua Pharmaceutical Co., Ltd.: Offers API production with certification aligned with international standards.
Indian Suppliers
India boasts a well-established API manufacturing sector, with companies specializing in veterinary pharmaceuticals and an expanding presence in human-use APIs.
- Strides Pharma Science Ltd.: Supplies veterinary APIs, including Triclabendazole, with GMP certification for export.
- Lupin Limited: Primarily focused on human pharmaceuticals but has scaled API manufacturing capacities for antiparasitics.
- Aurobindo Pharma: Manufactures various veterinary APIs, including formulations containing Triclabendazole.
European and North American Suppliers
While less prominent, some European and North American companies engage in licensing, distribution, or specialized manufacturing of Triclabendazole. These firms often acquire APIs from Asian manufacturers or produce formulations under strict regulatory oversight.
- IDT Australia: Engages in manufacturing APIs under strict compliance, with some offerings related to antiparasitic medications.
- Novartis (formerly): Was involved in the development of antiparasitic drugs, but currently no active commercial API production for Triclabendazole.
Regulatory and Certification Considerations
Suppliers must adhere to Good Manufacturing Practices (GMP) and possess relevant certifications such as ISO, WHO Prequalification, or FDA approvals, especially for human-use applications. Veterinary-grade APIs often have different standards but still require quality assurance for efficacy and safety.
Stakeholders should verify supplier documentation, batch sample testing, and registration status with relevant agencies (e.g., EDQM in Europe, USDA-APHIS in the US, or national health authorities) before procurement.
Key Market Players and Suppliers
| Supplier Name | Country | Product Type | Certification & Quality Standards | Focus Area |
|---|---|---|---|---|
| Sino An Pharmaceutical Co. Ltd. | China | API, Finished Formulation | GMP, ISO, Export License | Veterinary & Human |
| Shandong Xinhua Pharmaceutical | China | API | GMP, CE Certification | Veterinary |
| Lupin Limited | India | API, Formulations | GMP, ISO | Veterinary & Human |
| Strides Pharma Science Ltd. | India | API, Veterinary Formulations | GMP, WHO PQ | Veterinary |
| Aurobindo Pharma | India | API | GMP, ISO | Veterinary & Human |
Note: Further due diligence is advised to verify the current regulatory status and production capabilities of each supplier.
Market Trends and Future Outlook
- The demand for Triclabendazole has expanded due to increasing awareness of fascioliasis in livestock and occasional investigative use in human medicine.
- The ongoing need for reliable, high-quality APIs sustains notable procurement from Asian manufacturers. However, regulatory constraints and quality assurance demands are prompting some suppliers to seek international certifications.
- Supply chain disruptions caused by geopolitical factors, pandemic impacts, and regulatory bottlenecks can influence availability, urging stakeholders to diversify sourcing channels.
Emerging Suppliers
Some emerging Chinese and Indian firms are obtaining international certifications, attempting to establish themselves as reliable sources for regulated markets. Additionally, regional pharmaceutical companies are investing in R&D to develop alternative formulations, potentially diversifying supply options.
Supply Chain Challenges
Procurement of Triclabendazole involves navigating a complex landscape of quality assurance, regulatory approval, and logistical logistics. Key challenges include:
- Ensuring supplier compliance with international quality standards.
- Verifying the regulatory approval status of APIs in target markets.
- Managing supply chain risks from geopolitical tensions or export restrictions.
- Securing competitive pricing without compromising quality.
Conclusion
The leading suppliers of Triclabendazole are predominantly based in China and India, with enterprises capable of meeting international standards for veterinary and human pharmaceuticals. Due diligence is essential to assure quality, safety, and regulatory compliance. The ongoing evolution of the global pharmaceutical landscape emphasizes the importance of diversified sourcing strategies and adherence to regulatory standards.
Key Takeaways
- Market leaders in Triclabendazole supply are mainly Chinese and Indian manufacturers with established GMP certifications.
- Regulatory compliance and quality assurance are critical considerations; buyers must verify certifications before procurement.
- Supply chain stability may be impacted by geopolitical, logistical, and regulatory factors, requiring diversified sourcing.
- Emerging suppliers in Asia are increasingly obtaining international certifications, offering potential new sourcing avenues.
- Due diligence and ongoing monitoring of supplier capabilities are essential to ensure uninterrupted access to high-quality Triclabendazole.
FAQs
Q1: Is Triclabendazole approved for human use globally?
A1: No. Triclabendazole is approved for human treatment of fascioliasis in some countries, such as Australia and some European nations, but approval varies. Its primary use remains veterinary, and regulatory status should be verified per jurisdiction.
Q2: What are the primary considerations when sourcing Triclabendazole?
A2: Ensuring supplier compliance with GMP, verifying certificates of analysis, confirming the regulatory approval status in the target market, and assessing logistical reliability.
Q3: Are there any regional restrictions on importing Triclabendazole?
A3: Yes. Import regulations depend on the destination country's approval and registration status. Some countries may require specific licenses or registration for veterinary pharmaceuticals or APIs.
Q4: How can buyers ensure quality from Chinese or Indian API suppliers?
A4: By requesting detailed certification documents, conducting third-party audits, performing batch testing, and reviewing previous compliance records in relevant markets.
Q5: Are there any environmentally sustainable or ‘green’ suppliers of Triclabendazole?
A5: Some manufacturers are adopting environmentally friendly manufacturing practices, such as reducing waste and energy consumption. Buyers seeking sustainable options should inquire directly and verify environmental certifications.
References:
[1] European Directorate for the Quality of Medicines & Healthcare (EDQM). European Pharmacopoeia.
[2] Indian Pharmaceutical Association. Annual Report on API Manufacturing.
[3] Global Trade Magazine. China's Pharmaceutical Export Trends.
[4] US Food and Drug Administration (FDA). Guidelines on API Quality Standards.
[5] World Health Organization (WHO). Prequalification of Medicines Program.
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