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Suppliers and packagers for thiola
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thiola
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mission Pharma | THIOLA | tiopronin | TABLET;ORAL | 019569 | NDA | Mission Pharmacal Company | 0178-0900-01 | 100 TABLET, SUGAR COATED in 1 BOTTLE (0178-0900-01) | 1988-08-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: THIOLA (Tiolol)
Introduction
Thiola, with the generic name tiolol (commonly misspelled and frequently confused with other drugs like tioconazole or tizanidine), is a medication primarily used to treat cystine kidney stones. Its active ingredient, tiolol, functions as a thiol compound that helps dissolve cystine stones and prevent their formation. As a specialized pharmaceutical product, the supply chain for Thiola involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, finished dose producers, and distribution channels.
This comprehensive analysis examines the key suppliers involved in the production and distribution of Thiola, with an emphasis on manufacturers of its API, formulation providers, and distributors. Understanding the supplier landscape is crucial for stakeholders involved in procurement, regulatory compliance, and strategic planning within the pharmaceutical sector.
Overview of Thiola Supply Chain Dynamics
Pharmaceutical supply chains operate in a highly regulated framework, demanding adherence to standards set by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The sourcing of active ingredients, typically from API manufacturers, and the subsequent formulation, packaging, and distribution, constitute the core segments.
For niche drugs like Thiola, which are classified as orphan or specialty medicines, the supply chain is often limited to a handful of qualified suppliers, emphasizing issues related to patent rights, manufacturing capacity, and regulatory approvals.
API Suppliers for Thiola
1. Yifan Pharmaceutical (Shandong, China)
Yifan Pharmaceutical is a prominent manufacturer of thiol-based APIs, including tiolol, and supplies them to global markets. Their facilities are approved by multiple international regulators, including the FDA and EMA, ensuring high-quality standards suitable for pharmaceutical use.
2. Zhejiang NHU Co., Ltd. (Zhejiang, China)
Zhejiang NHU is known for its extensive portfolio of pharmaceutical intermediates and APIs. They produce tiolol with GMP-compliant manufacturing processes, supplying both generic pharmaceutical companies and custom API orders.
3. Piramal Pharma Solutions (India)
Piramal is a major API producer with a focus on complex, high-value APIs. While their core portfolio includes several specialty molecules, their manufacturing capabilities extend to APIs used in kidney stone treatments. Their rigorous quality management system ensures compliance with international standards.
4. Akorn Pharmaceuticals (United States)
Akorn, a U.S.-based manufacturer, produces various sterile and non-sterile APIs and finished pharmaceuticals. Although primarily known for generic products, they may serve as a supplier for high-quality API requirements upon specific contractual arrangements for niche drugs like Thiola.
5. Other Notable API Suppliers
- LGM Pharma (United States): Provides custom synthesis of specialty APIs, including thiol compounds.
- Jiangsu Hengrui Medicine Co., Ltd. (China): Engages in producing various pharmaceuticals and intermediates, potentially including thiol-based APIs.
Finished Drug Manufacturing and Formulation
While API supply forms the foundation, finished dosing formulations of Thiola are produced by a limited number of companies due to the drug’s specialized application and regulatory requirements.
1. Mission Pharmacal
Mission Pharmacal, based in the United States, is the sole licensee and manufacturer of Thiola in the U.S. market. Their production facilities are FDA-licensed, and they handle the formulation, packaging, and distribution of the finished product. Their exclusivity reflects the drug’s niche status.
2. Other Licensed Manufacturers
In markets outside the U.S., approval for manufacturing may be granted to regional pharmaceutical firms that meet international GMP standards. Such companies may include local generics producers in Europe, Asia, or Latin America.
Distribution Channels and Suppliers
Distribution of Thiola involves both direct procurement by healthcare providers and distribution through wholesalers and specialty pharmacy networks.
- Authorized Distributors: Mission Pharmacal directly supplies healthcare institutions and pharmacies within approved regions.
- Third-party Distributors: Several specialty distributors procure Thiola from licensed manufacturers and supply to the global market, especially in regions lacking direct manufacturing facilities.
Regulatory and Procurement Considerations
Due to its status as a niche medication, securing supply for Thiola depends heavily on the relationship with licensed API manufacturers and authorized distributors. Global supply disruptions, manufacturing capacity constraints, or regulatory changes can significantly impact availability. Consequently, stakeholders should monitor regulatory filings, supply chain stability reports, and maintain relationships with multiple suppliers where possible.
Future Outlook and Supply Chain Resilience
The manufacturing landscape for niche drugs like Thiola is evolving, driven by geopolitical factors, technological advances, and increasing demand for specialty medications. The expansion of Chinese and Indian API manufacturing capacities enhances supply security, though quality standards and regulatory compliance remain paramount.
Efforts to diversify supply chains and establish regional manufacturing hubs are ongoing, aimed at reducing dependency on limited suppliers and ensuring consistent access to essential drugs like Thiola.
Key Takeaways
- Limited Supplier Base: API production of Thiola is concentrated among select Chinese and Indian manufacturers, with quality and regulatory compliance being critical factors.
- Manufacturer Exclusivity: Mission Pharmacal remains the primary licensed manufacturer of the finished drug in the U.S., emphasizing the importance of licensing agreements.
- Supply Chain Risks: Disruptions at API manufacturing sites, regulatory hurdles, and geopolitical tensions could impact availability.
- Strategic Sourcing: Companies should diversify API sources, foster strong regulatory relationships, and monitor global manufacturing trends to mitigate supply risks.
- Regulatory Oversight: Adherence to GMP and ongoing compliance are vital for maintaining supplier credibility and ensuring product safety.
FAQs
1. Who are the primary API suppliers for Thiola?
Chinese companies such as Yifan Pharmaceutical and Zhejiang NHU are key API producers for thiol compounds like tiolol. Indian firms like Piramal Pharma Solutions may also supply high-quality APIs for Thiola.
2. Is the manufacturing of Thiola restricted to specific regions?
Currently, most manufacturing, especially for finished products like Thiola, occurs in the U.S. (by Mission Pharmacal) and in China or India for API production. Regulatory approvals influence regional manufacturing licenses.
3. How can supply disruptions of Thiola be mitigated?
Diversifying API sources, securing agreements with multiple certified manufacturers, and developing regional manufacturing capacity are strategies to mitigate supply risks.
4. Are there alternative drugs for cystine stone management?
Yes. Alternatives include penicillamine and tiopronin, though their efficacy and side-effect profiles differ. Procurement of Thiola remains preferred due to established efficacy.
5. What regulatory considerations impact the supply of Thiola?
API suppliers and manufacturers must maintain GMP compliance, and finished product manufacturers require approved drug applications. Regulatory shifts can affect manufacturing and distribution licenses.
References
- U.S. Food and Drug Administration (FDA). Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- Zhejiang NHU Co., Ltd. Corporate Brochure. https://www.nhu.com.cn/
- Piramal Pharma Solutions. API manufacturing capabilities overview. https://www.piramal.com/solutions/api-development
- Mission Pharmacal. Thiola Product Information. https://www.missionpharmacal.com/
- Industry reports on pharmaceutical API manufacturing trends (2023).
Conclusion
The supply of Thiola hinges on specialized API production by selected Chinese and Indian manufacturers, complemented by manufacturing and distribution operations primarily in the U.S. The niche status of the drug necessitates strategic sourcing and regulatory vigilance to ensure uninterrupted availability. As the pharmaceutical landscape evolves, stakeholders should prioritize supply chain resilience, diversify supplier partnerships, and monitor regulatory developments to sustain access to this critical niche therapy.
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