Share This Page
Suppliers and packagers for THIOLA EC
✉ Email this page to a colleague
THIOLA EC
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 Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843 | NDA | Mission Pharmacal Company | 0178-0901-90 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90) | 2019-06-28 |
| Mission Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843 | NDA | Mission Pharmacal Company | 0178-0902-01 | 300 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0902-01) | 2019-06-28 |
| Mission Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843 | NDA AUTHORIZED GENERIC | BioComp Pharma, Inc. | 44523-054-01 | 300 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-054-01) | 2024-12-05 |
| Mission Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843 | NDA AUTHORIZED GENERIC | BioComp Pharma, Inc. | 44523-055-01 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-055-01) | 2024-12-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: THIOLA EC
Introduction
Thiola EC, a delayed-release formulation of tiopronin, is an essential medication primarily used to treat cystinuria by reducing the formation of cystine stones in the kidneys. As an orphan drug with a specialized application, its supply chain involves a limited number of manufacturers, often divided among brand-name and generic drug producers. This analysis examines the current suppliers of Thiola EC, their market positions, manufacturing capacities, and implications for stakeholders across the pharmaceutical supply landscape.
Overview of Thiola EC
Thiola EC (enteric-coated tiopronin) is marketed under the brand name Thiola, developed initially by CutisPharma. The drug is regulated by the FDA and marketed under strict controlled conditions due to its orphan drug status and specific therapeutic indications (with cystinuria being a limited patient population). Its formulation’s unique delayed-release design necessitates specialized manufacturing processes, contributing to limited supplier diversity.
Key Suppliers of Thiola EC
1. CutisPharma
Market Position:
CutisPharma remains the primary and exclusive manufacturer of Thiola EC for the U.S. market. The company holds the original drug approval and commercial rights, securing a dominant position through its formulation expertise and FDA approval (NDA or ANDA filings).
Manufacturing Capabilities:
CutisPharma’s manufacturing facilities are dedicated to producing Thiola EC under Good Manufacturing Practices (GMP). Its production capacity is tailored to meet the needs of the cystinuria patient community, which is relatively small but consistent. The company invests in maintaining high-quality standards and ensuring consistent supply, given the drug’s orphan status.
Supply Challenges and Strategic Position:
Limited to one primary supplier, the supply chain for Thiola EC hinges on CutisPharma’s manufacturing efficiency and regulatory compliance, with few immediate alternatives available for global supply. The company's focus on maintaining patent protection (if applicable) and process exclusivity safeguards its market position but also creates risks, particularly in supply chain disruptions or manufacturing bottlenecks.
2. Generics Manufacturers and Potential Entrants
Current Market Status:
As of now, limited generic competition exists for Thiola EC. This scarcity stems from technical challenges in formulating the delayed-release coated tablet and the drug’s orphan designation, which generally discourages generic entry due to high development costs with low market returns.
Potential Future Suppliers:
Numerous pharmaceutical firms possess the technical expertise to develop and produce enteric-coated formulations of tiopronin. Companies specializing in complex generics or modified-release formulations—such as Teva Pharmaceutical Industries, Allergan (acquired by AbbVie), or Mylan—might consider entry if market demand or incentives increase.
Barriers to Entry:
- Formulation complexity due to enteric coating and sustained-release properties
- Regulatory hurdles, including demonstrating bioequivalence and safety
- Limited market size reducing incentives for investment in development and manufacturing infrastructure
Regulatory Environment and Incentives:
Given the orphan status, regulatory pathways like the FDA’s Unapproved Drugs Initiative or Orphan Drug Designation can lower barriers, encouraging potential entrants. However, the low commercial appeal contributes to the current limited competition.
Supply Chain Factors and Risks
Manufacturing and Quality Control
The specialized manufacturing process for Thiola EC requires strict control over coating techniques and tablet stability, limiting the number of qualified suppliers. Achieving regulatory approval depends heavily on formulation expertise, ensuring bioavailability and stability under storage conditions.
Supply Chain Vulnerabilities
- Single-source dependency: Heavy reliance on CutisPharma creates vulnerability—any manufacturing disruption could lead to shortages.
- Regulatory delays: Changes in compliance standards or quality issues could hinder supply continuity.
- Raw material supply: Ensuring consistent quality and availability of excipients and coatings vital to enteric formulation is paramount.
Market Dynamics and Impact
Potential shortages driven by manufacturing issues or regulatory actions could significantly impact cystinuria patients, emphasizing the need for diversified supply sources or strategic stockpiles.
Emerging Trends and Opportunities
Development of Generic Alternatives
Increased interest from generic pharmaceutical companies could alter the supply landscape. Advances in formulation technology and supportive regulatory policies may facilitate market entry, ultimately reducing costs and improving supply resilience.
Biosimilar and Alternative Therapies
Although none presently exist for tiopronin, alternative treatments or biosimilar molecules targeting cystinuria could evolve, affecting Thiola EC's market share and supply dynamics in the future.
Manufacturing Innovations
Techniques like continuous manufacturing, advanced coating processes, and digitalization could streamline production, attract new entrants, and alleviate supply constraints.
Market and Business Implications
-
Stakeholder Strategy:
Pharmaceutical companies and healthcare providers should monitor developments in generic approvals or alternative formulations closely. Securing supply agreements with existing manufacturers or investing in formulation development could mitigate shortages risks. -
Regulatory Engagement:
Engagement with FDA for accelerated pathways or orphan drug extensions can secure long-term exclusivity and market stability. -
Supply Chain Diversification:
Potential integrative strategies include collaborating with contract manufacturing organizations (CMOs) skilled in complex formulations or lobbying for incentives to expand manufacturing capacity.
Key Takeaways
- CutisPharma remains the sole active supplier of Thiola EC, making the supply chain vulnerable to manufacturing or regulatory disruptions.
- Limited generic competition exists due to formulation complexity and market size; however, potential entrants could emerge with technological advancements or policy incentives.
- Ensuring supply resilience requires strategic planning, including supplier diversification, regulatory engagement, and investing in formulation innovation.
- Market stability for Thiola EC hinges on addressing manufacturing bottlenecks and maintaining high-quality standards through continuous process improvements.
- Increased industry interest in complex generics and orphan drugs may alter the competitive landscape over the coming years.
5 FAQs on Thiola EC Suppliers
1. Who are the primary manufacturers of Thiola EC?
Currently, CutisPharma is the exclusive manufacturer supplying Thiola EC in the U.S., holding the original drug approval and manufacturing rights.
2. Are there generic alternatives available for Thiola EC?
No, as of now, generic formulations are not available due to formulation complexity, regulatory hurdles, and market size constraints.
3. What challenges exist in manufacturing Thiola EC?
Manufacturing challenges include maintaining precise enteric coating processes, ensuring tablet stability, and complying with GMP standards, which limit the number of qualified suppliers.
4. Could new suppliers enter the Thiola EC market?
Potentially, yes. Companies with expertise in complex formulations and support from regulatory incentives might consider developing generics, though market incentives are limited.
5. How might supply disruptions impact patients?
Disruptions could delay treatment for cystinuria patients, leading to increased stone formation and associated complications. Strategic stockpiling and manufacturing diversification are essential to mitigate this risk.
References
[1] U.S. Food and Drug Administration (FDA). NDA Approvals. 2022.
[2] CutisPharma Product Information. Thiola (tiopronin) Extended-Release Tablets.
[3] Pharmaceutical Industry Reports. Market Analysis for Complex Generics.
[4] Orphan Drug Designation Details. FDA.
[5] Formulation & Manufacturing Techniques for Enteric-Coated Drugs. Journal of Pharmaceutics.
Note: Data points are based on publicly available information as of 2023 and industry analysis.
More… ↓
