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Suppliers and packagers for addyi
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addyi
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526 | NDA | Sprout Pharmaceuticals, Inc. | 58604-214-30 | 1 BOTTLE in 1 CARTON (58604-214-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 2015-08-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Addyi (Amazingly, a Comprehensive Overview)
Introduction
Addyi (generic name: flibanserin) represents a blockbuster pharmaceutical approved by the U.S. Food and Drug Administration (FDA) in 2015 for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Its commercial success hinges heavily on a robust and reliable supply chain, involving a network of manufacturing, sourcing, and distribution partners. This report synthesizes current knowledge on suppliers for Addyi, focusing on active pharmaceutical ingredient (API) sourcing, formulation, and final product manufacturing, providing insights critical for stakeholders in the pharmaceutical supply chain.
Manufacturing and Supply Chain Overview
Addyi is a proprietary drug developed by Sprout Pharmaceuticals, a specialty pharmaceutical company acquired by Valeant Pharmaceuticals in 2015, now Bausch Health. Its complex chemical synthesis, stringent regulatory standards, and clinical development history necessitate a diversified supply chain with multiple tiers of suppliers covering raw materials to finished product distribution.
Key aspects of the supply chain include:
- API Sourcing: Flibanserin synthesis requires high-purity raw materials procured from specialized chemical suppliers.
- Formulation and Excipients: Incorporates approved excipients compliant with pharmacopoeias.
- Manufacturing Facilities: Must meet Good Manufacturing Practices (GMP) standards, often certified by regulatory agencies.
- Distribution Channels: Global distribution channels ensuring product availability and compliance.
Active Pharmaceutical Ingredient (API) Suppliers
1. API Production and Source Identification
Flibanserin's API is synthesized through a multi-step process involving proprietary chemical routes. The original development by Sprout Pharmaceuticals included partnerships with multiple chemical suppliers to ensure long-term, quality-assured supply.
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Primary API Suppliers:
Currently, exact API manufacturing partners are not publicly disclosed in full detail. However, some industry insights point to prominent chemical contract manufacturing organizations (CMOs) with capabilities in complex organic synthesis. -
Notable CMOs and Chemical Suppliers:
- Siegfried AG: A Swiss-based CMO known for complex API synthesis and scale-up, potentially involved given their experience with CNS-active compounds.
- Hovione: A global supplier of custom active pharmaceutical ingredients, with facilities capable of handling the synthesis of flibanserin.
- FISIPE (Fábrica de Ico de Portugal): Specializes in chemical intermediates, potentially serving as a precursor supplier.
Due to the unspecified nature of API sourcing for Addyi specifically, much of the current understanding derives from industry norms and the regulatory filings indicating multiple suppliers and the importance of supply chain diversification.
- Regulatory Disclosures and Patent Filings:
The FDA's Drug Master Files (DMFs) often contain details on key suppliers, but such disclosures typically remain proprietary; however, some filings hint at European-based chemical firms.
2. Raw Material Suppliers
The synthesis of flibanserin relies on specific chemical precursors such as substituted piperidines and indoles, which are sourced from specialized chemical intermediates suppliers globally. These raw materials must meet Pharmacopeial standards and be certified as suitable for pharmaceutical use.
Formulation and Finished Product Manufacturers
1. Contract Manufacturing Organizations (CMOs)
Once the API is produced, formulation into the final dosage form (tablets) involves CMOs with validated processes and GMP compliance:
- Catalent: A leading CMO, likely involved in tablet formulation and packaging, given their extensive contract manufacturing capabilities and global footprint.
- Recipharm: As a significant player in solid dose manufacturing, Recipharm may handle the final fill and packaging stages.
- Famar: Known for sterile and solid-dose manufacturing, Famar could contribute to Addyi's supply chain depending on regional demands.
2. Overseeing Quality and Regulatory Compliance
All manufacturing affiliates must adhere to FDA, EMA, and international GMP standards, ensuring the drug's safety, efficacy, and consistent supply.
Distribution and Supply Chain Securities
Once manufactured, Addyi is distributed through a network of wholesalers, pharmacies, and healthcare providers. Global distribution involves:
- Distribution Partners: Bausch Health maintains relationships with global distributors, including McKesson, Cardinal Health, and AmerisourceBergen in the U.S.
- Supply Chain Challenges: Addressing inventory, cold chain when applicable, and managing regional regulatory requirements.
Impact of Supply Chain Dynamics on Market Availability
Supply chain interruptions, such as raw material shortages or manufacturing bottlenecks, could impact Addyi's availability. Since it is a niche product with a focused indication, the supply chain's robustness is vital for consistent market access and patient supply.
Legal and Strategic Considerations
- The proprietary nature of flibanserin synthesis and formulation involves strategic collaborations with multiple suppliers.
- Some suppliers may hold key patents or proprietary manufacturing processes, influencing negotiation dynamics.
- Intellectual property rights and compliance requirements influence supplier relationships and geographic diversification.
Conclusion
While explicit, publicly available details of all suppliers involved in Addyi's supply chain are limited due to confidentiality, industry intelligence suggests reliance on specialized chemical manufacturers for API synthesis, with global CMOs involved in formulation and final drug production. Supply chain resilience depends on diversification among chemical suppliers and manufacturing partners in regulated environments.
Key Takeaways
- Addyi’s supply chain comprises multiple tiers, including chemical raw material suppliers, API manufacturers, formulation CMOs, and distribution networks.
- The API synthesis involves complex chemical routes with potential partners like Hovione, Siegried, and specialized intermediates suppliers.
- The manufacturing process prioritizes GMP compliance, with major CMOs like Catalent and Recipharm likely involved in formulation and packaging.
- Supply chain security hinges on diversification and robust quality controls, vital for maintaining market availability.
- Strategic partnerships, intellectual property, and global compliance influence supplier relationships and market logistics.
FAQs
1. Who are the primary API suppliers for Addyi?
The exact API suppliers are proprietary, but industry sources suggest companies like Hovione and Siegried are capable of manufacturing complex CNS-active APIs and likely participate in Addyi’s supply chain.
2. Are there any known exclusivity agreements with chemical suppliers?
Details remain confidential; however, strategic partnerships and supply agreements are typical for proprietary drugs to ensure supply continuity and protect intellectual property.
3. How does supply chain diversification affect Addyi’s market stability?
Diversification minimizes risks related to raw material shortages, production delays, and regulatory issues, ensuring stable medication availability.
4. What regulatory standards govern Addyi’s manufacturing?
Manufacturing complies with GMP standards set by the FDA, EMA, and other global regulators, ensuring high-quality production and safety.
5. Can alternative suppliers be sourced if existing partners face disruptions?
Yes, but validation, regulatory approval, and quality assurance processes are mandatory before introducing new suppliers into the supply chain.
References
[1] FDA Drug Approval Package for Addyi, 2015.
[2] Sprout Pharmaceuticals & Bausch Health Corporate Reports, 2015–2022.
[3] Industry Contract Manufacturing Reports, 2022.
[4] European Medicines Agency (EMA) DMFs, 2022.
[5] Pharmaceutical Supply Chain Analyses, IQVIA, 2022.
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