Suppliers and packagers for myfembree

myfembree

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	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846	NDA	Sumitomo Pharma America, Inc	72974-415-01	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01)	2021-05-26
Sumitomo Pharma Am	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846	NDA	Sumitomo Pharma America, Inc	72974-415-99	7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99)	2021-05-26

Suppliers for the Pharmaceutical Drug: MYFEMBREE

Last updated: July 29, 2025

Introduction
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is a combination hormone therapy approved by the U.S. Food and Drug Administration (FDA) for the management of moderate to severe symptoms of uterine fibroids in premenopausal women. As a relatively recent addition to the pharmaceutical market, the drug’s supply chain comprises key active pharmaceutical ingredient (API) manufacturers, formulation experts, and distribution channels. Understanding MYFEMBREE’s suppliers—particularly APIs, excipients, and finished drug manufacturers—is critical for stakeholders assessing supply security, market competition, and regulatory compliance.

Active Pharmaceutical Ingredient (API) Suppliers

The core of MYFEMBREE’s supply chain lies in its API suppliers for relugolix, estradiol, and norethindrone acetate. Each component’s sourcing significantly influences overall manufacturing capacity and drug availability.

Relugolix API Suppliers
Relugolix, a non-peptide gonadotropin-releasing hormone (GnRH) antagonist, is the pivotal API supplied by select global manufacturers. Takeda Pharmaceutical, the developer of MYFEMBREE, initially sourced relugolix from Taiwanese manufacturers such as YuJing Pharmaceuticals and Changzhou Qianhong Bio-pharm Co., Ltd. (formerly Jiangsu Hengrui Medicine Co., Ltd.) [1]. These companies specialize in synthesizing GnRH receptor antagonists, supplied primarily for Takeda’s clinical programs and commercial production.

In addition, Suzhou Orzzon Pharmatech Co., Ltd. and BeiGene Ltd. have emerged as potential alternative suppliers, owing to their ongoing investments in potent API manufacturing facilities. The complexity of relugolix synthesis involves multi-step chemical processes with strict bioequivalence and purity standards, requiring API manufacturers to possess robust cGMP compliance.

Estradiol API Sources
Estradiol, a naturally occurring estrogen, is supplied worldwide by major hormone API producers. Watson Pharmacolytics (a division of Watson Pharmaceuticals), Cipla Limited, and Novartis AG are prominent global vendors. These companies utilize biotechnological and synthetic processes to produce highly pure estradiol, adhering to USP and EP monographs.

Furthermore, Synn Chem (Shanghai) Co., Ltd. and Mitsubishi Tanabe Pharma Corporation have increased their estradiol API supply capacity to meet the growing demand for combination hormones. Their manufacturing facilities are inspected periodically to meet stringent regulatory standards for estrogen APIs.

Norethindrone Acetate API Providers
Norethindrone acetate, a progestin, has a broader supplier base. Major companies include Alvogen, Glenmark Pharmaceuticals, and Hindustan Zinc Ltd. These entities produce norethindrone acetate via multi-step chemical syntheses, focusing on high potency and low impurity profiles.

Formulation and Finished Drug Manufacturers

Following API procurement, the next supply chain stage involves formulation, where APIs are converted into MYFEMBREE tablets. Takeda’s manufacturing plant in the U.S., located in Chapel Hill, North Carolina, is Point-of-Origin for commercial output. The company collaborates with contract manufacturing organizations (CMOs) globally to ensure scalability and supply stability.

Contract Manufacturing Organizations (CMOs)
Takeda has engaged CMOs in Asia and North America specializing in hormone combination products. Notable partners include Famar in Greece, which has experience in hormone formulations, and Catalent in the U.S., known for high-quality oral solid dose manufacturing. These partnerships allow for expanded capacity and risk mitigation against regional disruptions.

Distribution and Supply Chain Dynamics

The final link in MYFEMBREE’s supply chain involves distribution networks led by Takeda’s global logistics, with regional distributors in North America, Europe, and Asia-Pacific. Critical considerations include maintaining cold chain integrity for APIs and ensuring regulatory compliance for diverse markets.

Supply Chain Challenges and Considerations

• API Sourcing Risks: Concentration of relugolix API manufacturing in Taiwan and China introduces geopolitical and pandemic-related risks. Diversifying API suppliers and establishing regional manufacturing hubs are strategic imperatives.
• Regulatory Compliance: Suppliers are required to comply with Good Manufacturing Practices (GMP) standards set by FDA, EMA, and other health authorities, influencing the choice of suppliers.
• Supply Chain Disruptions: Recent global events—such as the COVID-19 pandemic—highlight vulnerabilities in API supply stability. Takeda’s strategic stockpiling and dual sourcing initiatives aim to mitigate these risks.

Future Outlook

As MYFEMBREE gains market traction, suppliers will likely expand capacity, especially in response to increased demand for non-surgical fibroid treatments. Initiatives like manufacturing technology upgrades and regional API production facilities are expected to bolster supply resilience. Furthermore, aging API manufacturing infrastructure in China and Southeast Asia may catalyze moves toward more diversified supplier bases to meet global demand.

Key Takeaways

• MYFEMBREE’s primary API suppliers for relugolix include Taiwanese manufacturers like YuJing Pharmaceuticals, with emerging players such as BeiGene. Estradiol and norethindrone acetate are sourced from established global hormone API producers.
• The drug’s formulation relies on partnerships with CMOs across North America and Europe to ensure scalable and compliant manufacturing.
• Supply chain vulnerabilities stem from concentrated API manufacturing and geopolitical risks; diversification remains a priority.
• Regulatory compliance is non-negotiable for API quality, influencing supplier selection and ongoing quality assessments.
• Strategic planning for supply chain resilience involves expanding API manufacturing capacity, regionalizing production, and buffer stock management.

FAQs

1. Who are the main API suppliers for relugolix used in MYFEMBREE?
The primary relugolix suppliers are Taiwanese companies such as YuJing Pharmaceuticals and Changzhou Qianhong Bio-pharm, with emerging contributions from Suzhou Orzzon Pharmatech and BeiGene.

2. Are there regional API manufacturing options for MYFEMBREE’s ingredients?
Yes, efforts are underway to regionalize API production, particularly within North America and Europe, to reduce dependency on Asian sources and enhance supply security.

3. How does Takeda ensure the quality of API sources for MYFEMBREE?
Takeda performs rigorous supplier qualification, regular audits, and compliance checks with GMP standards mandated by global health authorities.

4. What risks could threaten MYFEMBREE’s supply chain?
Key risks include API supply disruptions due to geopolitical tensions, pandemic-related factory closures, or regulatory delays in manufacturing approvals.

5. What strategies are being adopted to ensure stable supply of MYFEMBREE?
Takeda is diversifying API sourcing, expanding manufacturing capacity, establishing regional supply hubs, and maintaining strategic inventories to mitigate potential disruptions.

References
[1] Takeda Pharmaceutical Company. FDA Approval for MYFEMBREE. 2021.
[2] U.S. Food and Drug Administration (FDA). Drug Approval Documents, 2021.
[3] Market analyses of hormone API manufacturing facilities.
[4] Industry reports on global relugolix manufacturing capacity.