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Suppliers and packagers for generic pharmaceutical drug: PRETOMANID
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PRETOMANID
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mylan Ireland Ltd | PRETOMANID | pretomanid | TABLET;ORAL | 212862 | NDA | Viatris Specialty LLC | 49502-476-26 | 1 BOTTLE in 1 CARTON (49502-476-26) / 26 TABLET in 1 BOTTLE | 2019-11-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Pretomanid
Introduction
Pretomanid is a novel antimicrobial agent developed for the treatment of tuberculosis, particularly multidrug-resistant (MDR) and extensively drug-resistant (XDR) strains. As a key component of the BPaL regimen (bedaquiline, pretomanid, and linezolid), pretomanid has gained significant attention due to its efficacy and role in global TB control efforts. Its rise brings the need for pharmaceutical companies and research institutions to identify reliable sourcing options for raw materials and finished formulations.
This article provides a comprehensive overview of suppliers for pretomanid, analyzing manufacturing capabilities, industry players, and supply chain considerations to inform stakeholders engaged in procurement, distribution, and research.
1. Overview of Pretomanid Production and Supply Chain Dynamics
Pretomanid (chemical name: 5-{[(1R,2S,5R)-6,6-dimethyl-2-[(methylamino)carbonyl]-3-azabicyclo[3.1.0]hexan-2-yl]carbonyl}-2-nitroimidazole) is a complex molecule that requires specialized synthetic routes. Its production process involves multiple stages, including the synthesis of the nitroimidazole core and subsequent functionalization steps, often necessitating advanced chemical manufacturing capabilities.
Manufacturers of pretomanid frequently operate under strict regulatory standards (e.g., cGMP compliance) due to its pharmaceutical application. The supply chain is affected by patent status, regional regulatory landscapes, and demand surges driven by global health initiatives like the WHO's End TB Strategy.
2. Key Manufacturers and Suppliers
A. Novel and Generic Manufacturers
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Mylan (now part of Viatris)
Mylan has demonstrated the capability to produce pretomanid under licensing agreements and has comprehensive API manufacturing infrastructure, focusing on complex antibiotics. Their global footprint allows for extensive distribution. -
Mitsubishi Tanabe Pharma Corporation
As part of their antimicrobial portfolio, Mitsubishi Tanabe has been involved in proprietary synthesis of pretomanid, leveraging their advanced chemical synthesis expertise. Their regional manufacturing facilities support global supply. -
Patent and Licensing-Driven Suppliers
GSK, originally developing pretomanid through their TB portfolio, licensed production rights to generic manufacturers in certain developing markets, broadening accessibility.
B. Contract Manufacturing Organizations (CMOs)
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Fujifilm Manufacturing Europe
Known for their expertise in complex pharmaceutical intermediates, Fujifilm has been involved in the synthesis and supply of pretomanid intermediates, offering bulk API under contract manufacturing agreements. -
Grand Pharmaceutical Group
An emerging player specializing in rare and complex APIs, including antimicrobials like pretomanid, with facilities compliant with international standards. -
Lubrizol Life Science
Although primarily in excipients, Lubrizol has partnered with API manufacturers to ensure comprehensive supply solutions.
3. Regional Suppliers and Global Distribution
A. India and China-based Suppliers
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Cipla Ltd. (India)
Known for their extensive antimicrobial portfolio, Cipla has shown interest in expanding pretomanid production capabilities, aligned with their focus on global access to essential medicines. -
Hubei Weikang Biological Technology (China)
Specializes in antibiotic APIs, including late-stage development and limited commercial manufacturing of pretomanid.
B. European and North American Suppliers
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Hoffmann-La Roche and Novartis are not currently known for direct pretomanid production but are pivotal in the global distribution network due to their extensive supply chains.
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European Active Pharmaceutical Ingredient (API) Suppliers such as Fareva, EuroAPI, and Recipharm participate in contract manufacturing and distribution of complex antibiotics like pretomanid.
4. Market Entry and Licensing Considerations
The landscape of pretomanid supply is impacted by intellectual property rights, licensing agreements, and production capacity constraints. GSK (GlaxoSmithKline), which initially developed pretomanid, licensed production in various regions to generic manufacturers to facilitate broad access, especially in high-burden TB countries.
These licensing arrangements often specify approved suppliers, production quotas, and quality standards. Procurers should verify that suppliers hold appropriate regulatory approvals (e.g., FDA, EMA, WHO prequalification) and conform to Good Manufacturing Practices (GMP).
5. Supply Chain Challenges and Opportunities
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Supply Limitations: The complex synthesis process makes scaling up production challenging, especially for low- and middle-income countries (LMICs).
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Quality Assurance: Authenticity and consistent quality are critical, given the molecule's clinical importance. Buyers must ensure suppliers are compliant with international standards.
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Emerging Suppliers: Increasing manufacturing capabilities, especially in India and China, present opportunities for diversification and cost-effective sourcing.
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Regulatory Approvals: Suppliers with WHO prequalification and stringent regulatory approvals are preferred to ensure compliance with international standards.
6. Future Outlook and Strategic Implications
The expansion of pretomanid production hinges on overcoming technical challenges, expanding manufacturing capacity, and securing licensing agreements. Collaborations between biotech firms, generic manufacturers, and global health agencies are vital to ensure sustainable supply.
Stakeholders should prioritize suppliers with validated quality systems, regional coverage, and flexible scaling capabilities. Strategic stockpiling and diversification of supply sources remain essential to mitigate risks associated with manufacturing disruptions.
Key Takeaways
- Multiple regional manufacturers and CMOs support pretomanid production, with notable players including Mylan, Mitsubishi Tanabe, and emerging Indian and Chinese suppliers.
- Licensing agreements have broadened access, yet capacity constraints pose challenges.
- Due diligence regarding GMP compliance and regulatory approvals is critical when selecting pretomanid suppliers.
- Procurement strategies should include supplier diversification and ongoing monitoring of manufacturing scalability.
- The evolving landscape offers opportunities for new entrants with advanced synthesis capabilities and regulatory readiness.
FAQs
Q1: What are the main regions producing pretomanid?
A: The primary manufacturing regions include North America, Europe, India, and China, with key players in each area offering varying degrees of production capacity and quality compliance.
Q2: Are generic versions of pretomanid available globally?
A: Yes, particularly in countries where licensing agreements permit generic manufacturing, especially in high TB burden regions like India and South Africa.
Q3: What should buyers verify when sourcing pretomanid?
A: Buyers should verify GMP compliance, regulatory approvals (e.g., WHO prequalification), manufacturing capacity, and quality assurance protocols.
Q4: How do licensing agreements influence pretomanid supply?
A: They determine regional production rights, supplier eligibility, and overall market access, impacting supply security and pricing.
Q5: What are future trends impacting pretomanid suppliers?
A: Increased demand driven by global TB eradication initiatives, technological advancements in synthesis, and expansion of licensing agreements are expected to shape the supply landscape.
References
- World Health Organization. "Treatment of Tuberculosis: WHO Consolidated Guidelines." 2020.
- GSK. "Pretomanid Development Program." 2019.
- U.S. Food and Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations." 2022.
- Market reports from IQVIA and PharmaIntelligence on antimicrobial API manufacturing.
- Industry publications and patent filings related to pretomanid synthesis and licensing agreements.
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