Suppliers and packagers for generic pharmaceutical drug: RELUGOLIX

RELUGOLIX

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621	NDA	Sumitomo Pharma America, Inc.	72974-120-01	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01)	2020-12-18
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621	NDA	Sumitomo Pharma America, Inc.	72974-120-95	16 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-95)	2020-12-18
Sumitomo Pharma Am	ORGOVYX	relugolix	TABLET;ORAL	214621	NDA	Sumitomo Pharma America, Inc.	72974-120-97	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-97)	2020-12-18

Suppliers for the Pharmaceutical Drug: Relugolix

Last updated: July 30, 2025

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Introduction

Relugolix, marketed under the brand name Orgovyx, is an oral, gonadotropin-releasing hormone (GnRH) receptor antagonist indicated primarily for the treatment of advanced prostate cancer and uterine fibroids. Developed and commercialized by Takeda Pharmaceutical Company Limited, relugolix's global supply chain is complex, comprising several key suppliers for active pharmaceutical ingredients (APIs), excipients, manufacturing, and distribution. Understanding the landscape of suppliers involved in relugolix’s production offers strategic insights for pharmaceutical stakeholders, investors, and healthcare providers.

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Manufacturing and Supply Chain Overview

Relugolix’s supply chain involves multiple stages:

• Active Pharmaceutical Ingredient (API) synthesis
• Formulation and final drug product manufacturing
• Packaging and distribution

Each stage depends on a specialized network of suppliers, many of which are integrated globally to ensure quality, compliance, and reliable supply.

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Active Pharmaceutical Ingredient (API) Suppliers

1. Core API Manufacturers

Takeda’s proprietary synthesis process for relugolix necessitates sourcing high-grade chemical intermediates and APIs from specialized chemical manufacturing firms. Although Takeda has established internal capabilities for final formulation, certain intermediates and raw materials are procured from third-party suppliers worldwide.

• Leading Chemical Contract Manufacturers:
  Many of relugolix’s intermediates are produced by global API contractors with proven compliance to Good Manufacturing Practices (GMP). These include firms based in Asia (notably China and India), which dominate the API manufacturing landscape due to cost efficiencies and extensive capacity.

• Examples (speculative, due to proprietary nature):
  While Takeda has not publicly disclosed exact suppliers, typical API suppliers for complex APIs like relugolix are large, Good Manufacturing Practice (GMP)-certified chemical manufacturers such as Hikal Ltd. (India), Jiangsu Hengrui Medicine Co., Ltd. (China), and Lubrizol Life Science, which supply intermediates or specialty chemicals.

2. Contract Development and Manufacturing Organizations (CDMOs)

Takeda leverages CDMOs for scalable API production, potentially contracting with firms such as Thermo Fisher Scientific or Catalent for development and early-stage manufacturing, and with specialized API manufacturers for large-scale production.

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Formulation and Final Product Manufacturing

• Contract Manufacturers (CMOs):
  The final dosage forms—tablets—are produced by global CMO partners with expertise in oral solid dose manufacturing.

• Key Entities:
  Takeda employs multiple CMO facilities, possibly including Famar, Recipharm, or Siegfried Holding AG, which are prominent in pharmaceutical manufacturing.

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Excipients and Auxiliary Materials Suppliers

Relugolix formulations require excipients standard in oral formulations, like fillers, binders, disintegrants, and lubricants. Major excipient suppliers include:

• DuPont Nutrition & Health
• BASF
• Dow Chemical

These companies supply standardized excipients compliant with pharmacopeia standards. The sourcing of excipients is typically global, with manufacturers maintaining inventories in anticipation of demand spikes.

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Regulatory and Quality Compliance

Suppliers involved in relugolix production must adhere to stringent quality control, GMP standards, and regulatory requirements set by agencies such as the FDA, EMA, and PMDA. Due diligence includes supplier audits, batch testing, and validation processes to ensure consistent product integrity.

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Distribution and Logistics

Once manufactured, relugolix APIs and finished products move through a global distribution network:

• Distribution Centers: Takeda maintains regional distribution hubs in the US, Europe, and Asia.
• Third-party Logistics Providers (3PLs): These include companies like DHL Supply Chain, FedEx Trade Networks, and UPS Healthcare, which facilitate global shipping, customs clearance, and delivery.

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Market Dynamics and Supplier Risks

Relugolix’s supply chain faces challenges such as geopolitical tensions, regulatory changes, and raw material shortages, especially in the context of increased demand driven by the drug’s therapeutic applications. Dependency on Asian API manufacturers introduces geopolitical and supply stability risks.

Takeda likely mitigates these risks through multiple sourcing strategies, qualifying several suppliers across different regions, and maintaining contingency inventories.

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Conclusion

Supply for relugolix hinges on a network of specialized API manufacturers, CMO partners for formulation, excipient providers, and logistics firms. While Takeda retains core manufacturing control, it relies heavily on global third-party suppliers, predominantly based in Asia, to meet demand and regulatory standards. The sustainability of this supply chain is critical amid growing global demand and geopolitical uncertainties, making supplier diversification and quality assurance paramount.

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Key Takeaways

• Relugolix’s API is sourced from specialized, GMP-compliant chemical manufacturers, primarily in Asia.
• Takeda employs a network of CMO and CMDO partners for formulation and manufacturing.
• Excipients come from leading chemical suppliers worldwide, ensuring formulation stability.
• Robust logistics and distribution networks underpin global supply, with contingency sourcing vital for resilience.
• Supply chain risks include geopolitical issues, raw material shortages, and regulatory hurdles, emphasizing the need for diversified sourcing strategies.

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FAQs

Q1: Who are the primary API suppliers for relugolix?
A1: While Takeda hasn’t publicly disclosed specific API suppliers, it likely sources from GMP-certified chemical manufacturers in China and India, such as Hikal Ltd. and Jiangsu Hengrui Medicine.

Q2: Does Takeda manufacture relugolix internally or rely on third parties?
A2: Takeda primarily relies on third-party CMOs and CDMOs for formulation, manufacturing, and scaling, while maintaining control over API sourcing and final assembly.

Q3: What are the main risks associated with relugolix’s supply chain?
A3: Risks include geopolitical tensions, raw material shortages, quality compliance issues, and regulatory delays, especially given the global dependence on Asian manufacturing.

Q4: Are there alternative suppliers for relugolix’s excipients?
A4: Yes, excipients are sourced from global chemical companies like BASF and Dow Chemical, offering multiple supply options to mitigate shortages.

Q5: How might supply chain disruptions impact relugolix availability?
A5: Disruptions could lead to delays in production, stock shortages, increased costs, and potential drug shortages, underscoring the importance of supplier diversification and inventory management.

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References

1. Takeda Pharmaceutical Company Limited. (2022). Relugolix (Orgovyx) Data Sheet.
2. U.S. Food and Drug Administration (FDA). (2021). Approval Documents for Relugolix.
3. Market research reports on API manufacturing, 2022.
4. Industry analyses of global API suppliers, 2022.
5. GxP guidelines for pharmaceutical raw material sourcing.

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End of Article