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Suppliers and packagers for generic pharmaceutical drug: elbasvir; grazoprevir
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elbasvir; grazoprevir
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | ZEPATIER | elbasvir; grazoprevir | TABLET;ORAL | 208261 | NDA | Merck Sharp & Dohme LLC | 0006-3074-02 | 2 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01) | 2016-01-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs Elbasvir and Grazoprevir
Introduction
Elbasvir and grazoprevir are antiviral agents developed and marketed primarily for the treatment of hepatitis C virus (HCV) infections. These drugs are often combined into a single dosage formulation under the brand name Zepatier, among others. As with many pharmaceutical compounds, their supply chain comprises multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, formulation producers, and distributors worldwide. Understanding the suppliers for elbasvir and grazoprevir is crucial for stakeholders involved in drug procurement, manufacturing, and regulatory oversight.
This analysis explores the key suppliers of these compounds, their manufacturing landscapes, and the implications for the pharmaceutical supply chain.
Overview of Elbasvir and Grazoprevir
Elbasvir (a NS5A inhibitor) and grazoprevir (a NS3/4A protease inhibitor) work synergistically to inhibit HCV replication. Developed by Merck Sharp & Dohme (MSD), the combination therapy targets multiple points in the viral life cycle, enhancing efficacy and reducing resistance.
As innovative pharmaceuticals, their production relies on sophisticated chemical synthesis and advanced manufacturing capabilities. The export and distribution depend on an extensive global network of suppliers, some of whom are specialized API manufacturers, while others are large-scale generic manufacturers or contract manufacturing organizations (CMOs).
Key Suppliers of Elbasvir and Grazoprevir
Active Pharmaceutical Ingredient (API) Manufacturers
1. Merck Sharp & Dohme (MSD)
- Role: Original patent holder and primary supplier of APIs.
- Manufacturing Capabilities: MSD maintains proprietary manufacturing facilities for elbasvir and grazoprevir, ensuring controlled manufacturing processes that comply with Good Manufacturing Practices (GMP).
- Supply Chain Position: As the originator, MSD’s APIs are the primary source for innovator formulations, although capacity constraints and patent protections influence licensing and licensing agreements.
2. Contract Manufacturing Organizations (CMOs) and Outsourced Suppliers
The global pharmaceutical industry increasingly relies on CMOs specializing in complex chemical synthesis for active ingredients, especially for molecules like elbasvir and grazoprevir, which require high precision and quality standards.
- Sygnature Discovery (UK): Known for synthesis expertise, though primarily in early-stage development rather than large-scale API production.
- Hikal Ltd. (India): Engaged in the synthesis of complex APIs, including hepatitis C drugs, potentially including grazoprevir.
- Dr. Reddy's Laboratories (India): Has capabilities to manufacture similar antiviral APIs and may serve as a secondary supplier or a licensed manufacturer for drugs like grazoprevir.
Note: Specific API sources for elbasvir and grazoprevir are often commercially sensitive; detailed supply chain disclosures are limited due to proprietary and competitive considerations.
Generic Suppliers and Regional Manufacturers
Following patent expiration or through licensing agreements, several generic manufacturers entered the market:
- Mylan/Nykode (India): Reported to have developed generic formulations, potentially sourcing APIs from regional suppliers.
- Cipla (India): Possesses the manufacturing capacity for hepatitis C drugs, possibly including APIs or finished formulations of elbasvir and grazoprevir.
- Hetero Labs (India): Known for producing generic antiviral drugs, including compounds similar to grazoprevir.
Implication: These manufacturers typically source APIs from local or regional suppliers, often relying on Indian or Chinese API producers.
Chinese API Suppliers
China is a significant global hub for API manufacturing due to cost-effectiveness and manufacturing scale.
- Shanghai Fosun Pharmaceutical: Has the capacity to produce APIs for hepatitis C drugs.
- Zhejiang Huahai Pharmaceutical: Known for complex APIs, including antiviral compounds.
- Jiangsu Hancin Pharmaceutical: Operates large-scale API manufacturing facilities, possibly supplying grazoprevir.
Caveat: The quality, purity, and regulatory compliance of Chinese API sources vary, necessitating thorough audits and quality assessments by downstream manufacturers.
Supply Chain Dynamics and Challenges
Regulatory and Quality Considerations
API sourcing involves strict regulatory oversight. Agencies such as the FDA, EMA, and PMDA require rigorous documentation and GMP compliance. Many manufacturers outside of originator companies face scrutiny, especially Chinese and Indian suppliers, due to past incidences of quality issues. Consequently, pharmaceutical companies often diversify suppliers to mitigate risks.
Patent and Licensing Issues
While the U.S. and EU markets experienced patent protections for elbasvir and grazoprevir, many jurisdictions have seen patent expirations or licensing agreements facilitate generics. Licensing arrangements affect API supply by enabling approved manufacturers to produce these compounds legally.
Impact of Geopolitical Factors
Trade tensions and import-export restrictions influence API availability. In recent years, concerns over supply chain transparency and geopolitical stability have led to diversified sourcing strategies and increased regional manufacturing investments.
Supply Chain Trends and Future Outlook
- Vertical Integration: Pharmaceutical companies increasingly develop in-house capacities for API production to ensure quality and supply security.
- Local Manufacturing Accelerations: Governments encourage local API manufacturing to reduce reliance on imported APIs.
- Emerging Markets: Countries like India and China continue to expand their API manufacturing footprint, aiming to capture a larger share of the global market.
- Technological Innovations: Advanced synthesis methodologies and continuous manufacturing processes are expected to enhance supply reliability and reduce costs.
Key Takeaways
- The original API suppliers for elbasvir and grazoprevir are primarily affiliated with MSD, with licensed or secondary manufacturing conducted by regional CMOs, mainly in India and China.
- The global pharmaceutical industry’s reliance on Asian API producers introduces both cost benefits and quality considerations, necessitating rigorous supplier qualification.
- Regulatory scrutiny significantly impacts API sourcing strategies; manufacturers prioritize suppliers with proven compliance records.
- Patent expiries and licensing agreements influence the availability of generics and the composition of supply chains.
- Supply chain resilience is increasingly prioritized through diversification, regional manufacturing investments, and technological advancements.
FAQs
1. Who are the main suppliers of elbasvir and grazoprevir APIs globally?
The original API manufacturers are affiliated with MSD, with secondary sources including Indian and Chinese biotech and API manufacturing firms such as Hikal, Dr. Reddy’s, Zhejiang Huahai, and Jiangsu Hancin. Precise supplier details are often proprietary.
2. Are generic manufacturers sourcing APIs directly from China or India?
Most generic manufacturers source APIs from regional Chinese and Indian suppliers, often through licensed manufacturing agreements or direct procurement, depending on regulatory compliance and quality standards.
3. How does patent expiration impact API supply for elbasvir and grazoprevir?
Patent expirations facilitate the production of generics, leading to increased API manufacturing and supply from multiple players, which can improve availability and reduce prices.
4. What are the supply risks associated with Chinese API manufacturers?
Risks include variability in quality, regulatory compliance, and geopolitical factors impacting trade and import-export policies. These are mitigated through supplier qualification and quality audits.
5. What future trends could affect API supply for these drugs?
Investments in local API manufacturing, technological innovations such as continuous manufacturing, and increased regulatory scrutiny are expected to shape supply stability and scalability.
References
- [1] Merck official product page: Zepatier data (https://www.merck.com/products/zepatier/)
- [2] U.S. FDA Drug Approvals and Patent Data (https://www.accessdata.fda.gov/)
- [3] Market research reports on API manufacturing hubs: Indian and Chinese pharmaceutical industries.
- [4] WHO Good Manufacturing Practices guidelines.
- [5] Reports on patent status and licensing agreements in hepatitis C antivirals.
Note: Due to proprietary and competitive reasons, specific API manufacturer identities and volumes are often confidential; the above is based on publicly available industry data and reports.
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