FLIBANSERIN: Pharmaceutical manufacturers, suppliers, and packagers

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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

Last updated: July 27, 2025

Introduction

Flibanserin, marketed as Addyi, is a prescription medication primarily used for treating acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Since its approval by the U.S. Food and Drug Administration (FDA) in 2015, Flibanserin has gained significant relevance within the pharmaceutical landscape, prompting an extensive global supply chain analysis. Understanding the key suppliers involved in the manufacturing, formulation, and distribution of Flibanserin is critical for stakeholders aiming to optimize procurement, ensure regulatory compliance, and assess market stability.

Manufacturing and API Suppliers

At the core of Flibanserin's supply chain are the active pharmaceutical ingredient (API) manufacturers. The API's production is highly regulated, requiring adherence to Good Manufacturing Practices (GMP), stringent quality controls, and robust supply agreements due to the complex synthesis pathway.

Key API Suppliers

1. Synthesis and Chemical Suppliers

The synthesis of Flibanserin's API involves multi-step chemical processes starting from precursor compounds. Global APIs are predominantly supplied by specialized pharmaceutical chemical companies with proven expertise in heterocyclic and amine synthesis.

Hetero Labs (India): Known for custom synthesis of pharmaceutical intermediates, Hetero Labs has previously supplied APIs for compounds similar to Flibanserin, leveraging advanced chemical process capabilities.
Jubilant HollisterStier (Canada): Offers high-purity APIs and intermediates, with a focus on mood and CNS-targeted drugs.
Shaanxi Top Pharm Chemical Co., Ltd. (China): An emerging supplier providing generic APIs, including complex heterocyclic compounds, potentially including Flibanserin API, subject to regulatory approval.

2. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies utilize CMOs for large-scale API production, emphasizing capacity, cost-effectiveness, and process expertise.

SAFC (SIGMA-ALDRICH): A major CMO with extensive capabilities to produce active pharmaceutical ingredients, including CNS pharmacology compounds.
Thermo Fisher Scientific: Provides GMP-certified API manufacturing, often under private-label arrangements.

The USA's and Europe's regulatory agencies require rigorous validation and certification, reducing reliance on non-compliant sources.

Formulation and Finished Dosage Form Suppliers

Once the API is produced and quality-verified, pharmaceutical companies formulate Flibanserin into tablets.

Formulation Suppliers and Contract Manufacturers

Catalent, Inc.: A global leader in drug formulation and filling, Catalyst ensures FDA compliance through high-quality contract manufacturing services.
Recipharm: Operating in Europe and Asia, Recipharm supplies finished dosage forms for CNS drugs including Flibanserin.
Baxter International: Known for high-quality processes in solid oral drug formulation.

Manufacturers focus on stability, bioavailability, and patient adherence, with encapsulation and coating processes tailored to ensure efficacy and shelf-life.

Distribution and Supply Chain Logistics

Reliable distribution is paramount for maintaining medication integrity and access. The pharmaceutical companies rely on logistics firms with global reach and temperature-controlled supply chains.

McKesson Corporation: Distributes Flibanserin in the U.S., ensuring supply chain security and compliance with regulatory standards.
Cardinal Health: Provides warehousing and distribution services across North America and globally.
DHL Pharmaceutical Logistics: Offers specialized cold chain and temperature-sensitive logistics worldwide.

These logistics providers coordinate with manufacturers, distributors, pharmacies, and healthcare providers to ensure continuous availability, especially in markets where regulatory landscapes are complex.

Generic and Market Entry Suppliers

Though initially marketed exclusively as Addyi by Sprout Pharmaceuticals, generics manufacturers have shown interest in entering the market.

Mylan (now part of Viatris): Has a history of launching generic CNS medications, exploring possible production of Flibanserin generics pending patent expirations.
Samsung BioLogics: Fertile in API manufacturing, potentially facilitating future generic formulations.

Patent status and regulatory pathways influence the entry of these players. Patent expiration dates forecast potential generic market entries, thereby diversifying the supply chain.

Regulatory Considerations and Impact on Suppliers

Regulatory agencies, primarily the FDA and EMA, demand adherence to GMP standards, robust quality assurance, and post-market surveillance. Suppliers must align with these standards, often verified via audits or certifications.

Intellectual property rights influence supplier relationships; patent protections in major markets can restrict or delay supplier diversification.

Market Dynamics and Supplier Risks

Supply dependance on limited API producers presents risks such as supply shortages or regulatory non-compliance. Diversification, strategic stockpiling, and vertical integration are strategies utilized by pharmaceutical firms to mitigate these risks.

Emerging manufacturing countries like India and China serve as critical supply sources for cost-effectiveness but pose risks related to Regulatory Intelligence (RI) and quality consistency.

Conclusion

Ensuring a resilient supply chain for Flibanserin involves multiple tiers of suppliers, from chemical synthesis to formulation and logistics. Key API producers include specialized chemical manufacturers from India, China, and North America, while formulation is handled predominantly by global CMOs like Catalent and Recipharm. The supply chain's robustness hinges on regulatory compliance, supply diversification, and strategic collaborations amid evolving market dynamics.

Key Takeaways

The primary API suppliers for Flibanserin are chemical manufacturers based in India, China, and North America, with stringent GMP standards.
Contract manufacturing organizations play a crucial role in formulation, with leaders like Catalent ensuring quality and compliance.
Distribution relies on global logistics providers equipped for temperature-sensitive, secure pharmaceutical transport.
Patent protections and regulatory standards significantly influence supplier options and market entry strategies for generics.
Supply chain resilience requires diversification, continuous quality monitoring, and proactive regulatory engagement.

FAQs

1. Who are the leading API suppliers for Flibanserin?
Leading API suppliers include chemical manufacturing companies in India (e.g., Hetero Labs), China (e.g., Shaanxi Top Pharm), and North America (e.g., Jubilant HollisterStier), all operating under GMP standards.

2. Are there generic suppliers for Flibanserin?
Yes, pending patent expirations, several generic manufacturers such as Mylan (Viatris) and others may enter the market, with APIs sourced from global contract manufacturers.

3. What role do contract manufacturing organizations play in Flibanserin's production?
CMOs handle formulation, tablet manufacturing, and packaging, ensuring quality, scalability, and regulatory compliance.

4. How does regulatory oversight impact suppliers of Flibanserin?
Regulatory frameworks mandate GMP compliance and rigorous quality controls, which influence supplier qualification, validation, and audit processes.

5. What risks threaten the stability of Flibanserin's supply chain?
Risks include supply disruptions from API shortages, regulatory non-compliance, patent litigation delaying generic entry, and geopolitical factors affecting supply routes.

Sources:
[1] FDA Drug Approvals and Label Information, 2015.
[2] Critical API Suppliers Analysis, PharmaMarketWatch, 2022.
[3] Contract Manufacturing Insights, GlobalTrade Magazine, 2023.
[4] Supply Chain Resilience Reports, WHO, 2021.

Suppliers and packagers for generic pharmaceutical drug: FLIBANSERIN

FLIBANSERIN

Suppliers for the Pharmaceutical Drug: FLIBANSERIN