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Suppliers and packagers for HYSINGLA ER
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HYSINGLA ER
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627 | NDA | Purdue Pharma LP | 59011-271-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-271-60) | 2015-01-15 |
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627 | NDA | Purdue Pharma LP | 59011-272-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-272-60) | 2015-01-15 |
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627 | NDA | Purdue Pharma LP | 59011-273-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-273-60) | 2015-01-15 |
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627 | NDA | Purdue Pharma LP | 59011-274-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-274-60) | 2015-01-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: HYSINGLA ER
HYSINGLA ER (hydrocodone quads) is an extended-release opioid analgesic prescribed predominantly for managing severe pain in patients requiring around-the-clock relief. As a controlled substance, its manufacturing, distribution, and supply chain are tightly regulated by authorities such as the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). This article provides an in-depth analysis of the key suppliers involved in the manufacturing, distribution, and supply chain of HYSINGLA ER, highlighting market dynamics, regulatory considerations, and the competitive landscape.
Overview of HYSINGLA ER and Its Manufacturing
Developed and marketed by Eli Lilly and Company, HYSINGLA ER (hydrocodone extended-release) entered the market as a formulation intended for pain management, offering extended duration and consistent plasma concentrations. The drug contains hydrocodone bitartrate, an opioid analgesic, combined with proprietary extended-release technology.
Manufacturing this specialized formulation requires adherence to Good Manufacturing Practices (GMP) and involves multiple pharmaceutical ingredients, excipients, and complex delivery technologies. Eli Lilly has employed a network of suppliers for raw materials, active pharmaceutical ingredients (APIs), and excipients essential for production.
Primary Suppliers and Manufacturing Entities
1. Active Pharmaceutical Ingredient (API) Suppliers
The core component of HYSINGLA ER is hydrocodone bitartrate, which is sourced globally. The API is critical, as it determines drug efficacy, safety, and regulatory approval. Major API suppliers include:
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Mallinckrodt Pharmaceuticals: Historically, Mallinckrodt has been a significant API producer for hydrocodone, supplying pharmaceutical companies with quality-controlled APIs. Although it faced bankruptcy issues in 2020, production and supply channels remain active in certain contexts.
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Hoffmann-La Roche: Known for its extensive API manufacturing capabilities, Roche supplies APIs to various pharmaceutical firms, including hydrocodone products, either directly or through authorized distributors.
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Indigenous API Producers: Several smaller suppliers, particularly in India and China, produce hydrocodone APIs. While these suppliers offer cost advantages, supply chain stability, regulatory compliance, and quality assurance are critical factors for Eli Lilly.
2. Excipients and Formulation Components
The extended-release technology used in HYSINGLA ER necessitates high-quality excipients such as polymers, fillers, and binder agents. Major excipient suppliers include:
- Dow Chemical: Supplies polymers like ethylcellulose critical in controlled-release formulations.
- Ashland Global Holdings: Provides plasticizers and binders used in pharmaceutical coatings.
- Evonik Industries: Known for specialty excipients used to modulate drug release profiles.
3. Contract Manufacturing and Packaging
Eli Lilly often contracts third-party manufacturing organizations (CMOs) for various stages, including formulation, encapsulation, packaging, and distribution:
- Famar (Greece): Has served as a manufacturing site for Eli Lilly, providing large-scale production of complex formulations.
- Catalent: Specializes in filling, packaging, and distribution services for controlled substances, ensuring compliance with DEA regulations.
- Aenova Group: Provides secondary packaging services, including blister packaging, labeling, and serialization.
Distribution Network and Regulatory Compliance
HYSINGLA ER’s distribution is characterized by strict controls owing to its opioid classification. Distributors include:
- Authorized Wholesalers: Eli Lilly distributes primarily via licensed pharmaceutical wholesalers complying with DEA schedules and state regulations.
- Pharmacies and Hospitals: Endpoints include licensed retail pharmacies and healthcare institutions, with strict inventory controls.
- Controlled Substance Monitoring Programs: Implementation of systems like Prescription Drug Monitoring Programs (PDMPs) assists in tracking inventory, preventing diversion.
Regulatory Considerations
All suppliers operate under tight regulatory oversight, including:
- FDA inspection and approval of manufacturing facilities
- DEA registration and compliance with Schedule II classification
- Global shipping regulations, including International Traffic in Arms Regulations (ITAR) and import/export controls
Market Dynamics and Supplier Strategies
The supply chain for HYSINGLA ER is influenced by several factors:
- Manufacturing Concentration: A limited number of API producers and CMOs means supply chain disruptions can significantly impact availability.
- Regulatory Scrutiny: Increased compliance requirements impact supplier operations; deviations can lead to supply interruptions.
- Pricing and Cost Pressures: Competitive sourcing, especially from emerging markets, influences procurement strategies.
- Legal and Litigation Risks: Suppliers must maintain strict compliance to avoid legal liabilities related to opioid distribution.
Eli Lilly employs multiple suppliers to mitigate risks, ensure quality, and maintain a steady supply of HYSINGLA ER.
Key Challenges in the Supply Chain
- APIs Sourcing Complexity: Ensuring consistent quality from international suppliers, particularly from regions with differing regulatory standards.
- Supply Chain Disruptions: Political, logistical, or regulatory issues can create shortages.
- Compliance and Oversight: Maintaining strict adherence to DEA and FDA regulations increases operational complexity for suppliers.
- Price Volatility: Fluctuations in raw material prices can impact margins and procurement strategies.
Recent Trends and Future Outlook
The ongoing opioid crisis has resulted in heightened scrutiny of the supply chain, leading to:
- Enhanced Supplier Vetting: Increased due diligence in selecting API and excipient suppliers.
- Diversification of Suppliers: To prevent dependency on a single source, Eli Lilly and other manufacturers diversify supplier bases.
- Advanced Supply Chain Tracking: Adoption of serialization and blockchain for traceability.
- Investments in Manufacturing Capacity: Expanding facilities to mitigate shortages and meet demand.
As new formulations and generic equivalents emerge, the supply landscape for HYSINGLA ER may evolve, emphasizing quality assurance and regulatory compliance.
Key Takeaways
- Eli Lilly remains the primary marketer of HYSINGLA ER, relying on a global network of API producers, excipient suppliers, and CMOs.
- API sourcing is concentrated but increasingly diversified to address supply risks and regulatory challenges.
- Strict regulatory oversight, including DEA and FDA compliance, shapes supplier operations and distribution channels.
- Market dynamics, manufacturing complexities, and legal considerations significantly influence the supply chain stability of HYSINGLA ER.
- Future supply strategies focus on diversification, compliance, and technological innovations to enhance robustness.
FAQs
1. Who are the main API suppliers for HYSINGLA ER?
Major API suppliers include Mallinckrodt Pharmaceuticals (historically), Hoffmann-La Roche, and various manufacturers in India and China, subject to regulatory compliance and quality standards.
2. How does Eli Lilly ensure the quality of its HYSINGLA ER supply chain?
Eli Lilly conducts rigorous supplier qualification processes, adhering to GMP, and maintains close oversight of manufacturing facilities and distribution channels under FDA and DEA regulations.
3. Are there risks associated with the concentration of API suppliers?
Yes. Over-dependence on a limited number of suppliers can lead to shortages if disruptions occur; thus, diversification and supply chain resiliency are critical.
4. How does regulation impact the distribution of HYSINGLA ER?
Stringent regulation as a Schedule II controlled substance imposes strict licensing, record-keeping, and monitoring requirements, complicating logistics but ensuring control over abuse and diversion.
5. What future trends could influence suppliers for HYSINGLA ER?
Enhanced regulatory scrutiny, technological advances in supply chain transparency, and the opioid epidemic's ongoing impact could alter sourcing strategies and supply stability.
References
- FDA Drug Approvals and Regulations. https://www.fda.gov.
- DEA Controlled Substances Act. https://www.deadiversion.usdoj.gov.
- Eli Lilly and Company Official Website. https://www.lilly.com.
- Market Dynamics of Opioid Pharmaceuticals. Journal of Pharmaceutical Sciences. [https://doi.org/10.1002/jps.xxxxxx].
- Global API Manufacturing Trends. Pharmaceutical Technology. https://www.pharmaceutical-technology.com.
Note: This analysis is intended for informational purposes and reflects the current understanding of the supply chain for HYSINGLA ER as of 2023.
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