Suppliers and packagers for generic pharmaceutical drug: zuranolone

zuranolone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369	NDA	Biogen MA Inc.	64406-029-01	1 BOTTLE in 1 CARTON (64406-029-01) / 14 CAPSULE in 1 BOTTLE	2023-10-31
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369	NDA	Biogen MA Inc.	64406-030-01	1 BOTTLE in 1 CARTON (64406-030-01) / 14 CAPSULE in 1 BOTTLE	2023-10-31
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369	NDA	Biogen MA Inc.	64406-030-02	1 CARTON in 1 CARTON (64406-030-02) / 1 BLISTER PACK in 1 CARTON / 28 CAPSULE in 1 BLISTER PACK	2023-10-31
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369	NDA	Biogen MA Inc.	64406-031-01	1 BOTTLE in 1 CARTON (64406-031-01) / 14 CAPSULE in 1 BOTTLE	2023-10-31

Suppliers for the Pharmaceutical Drug: Zuranolone

Last updated: July 29, 2025

Introduction

Zuranolone (development code: SAGE-217) is an investigational neuroactive steroid under development for treating major depressive disorder (MDD), postpartum depression (PPD), and other neuropsychiatric conditions. Its unique mechanism of action involves positive modulation of GABA_A receptors, leading to rapid antidepressant effects. Given the growing interest in neuropsychiatric therapeutics, understanding the supply landscape for zuranolone is crucial for stakeholders across the pharmaceutical industry, healthcare providers, and investors. This report consolidates current information regarding suppliers involved in the manufacturing, sourcing, and distribution of zuranolone.

---

Manufacturing Landscape of Zuranolone

Zuranolone is a synthetic pharmaceutical compound, primarily manufactured by its patent-holding entity or licensed contract manufacturing organizations (CMOs). As of 2023, the drug remains in late-stage clinical trials, with no finalized commercial manufacturing agreements publicly disclosed. However, several key players are actively involved in the supply chain:

Sage Therapeutics

Sage Therapeutics is the innovator behind zuranolone, holding the core patents and overseeing its development. The company's expertise extends to large-scale synthesis and formulation tailored toward clinical trial needs. Sage’s strategic partnerships with CMOs are crucial for ensuring a reliable supply:

• In-house Manufacturing Capabilities: Sage maintains specialized facilities for early-phase production. While details are proprietary, their rigorous quality control systems support clinical trial material (CTM) production.

• Contract Manufacturing Partners: Sage has reported collaborations with third-party CMOs for scale-up processes necessary for phase 3 trials and potential commercial phases (clinical trial disclosures, 2022-2023). These include companies with proven track records in sterile pharmaceutical manufacturing but specific names remain undisclosed in public documents.

Contract Manufacturing Organizations (CMOs)

As the commercialization phase approaches, multiple CMOs are expected to be involved in the manufacturing of zuranolone at commercial scale. Notably:

• Yokogawa Electric Corporation (Japan): Known for high-precision chemical synthesis capabilities, potentially involved in API (Active Pharmaceutical Ingredient) production.

• Baxter Healthcare, Lonza, or Siegfried: These firms are leaders in sterile APIs and complex molecule synthesis, standing as potential partners for large-scale production pending Sage's strategic alliances.

API Suppliers for Zuranolone

The key to manufacturing zuranolone is sourcing high-purity API. Currently, the API synthesis involves complex steroid chemistry, requiring specialized chemical reactions and purification. Leading chemical suppliers in the steroid synthesis space include:

• Evonik Industries: Known for steroid intermediates, potentially serving as API intermediaries.

• Thermo Fisher Scientific: While primarily a reagent supplier, Thermo Fisher provides custom synthesis services, possibly supporting urgent supply needs.

• Indigenous chemical manufacturers in China and India: With the expansion of global chemical synthesis capabilities, several generic chemical producers may supply intermediate compounds under licensing or consignment agreements.

---

Distribution and Supply Chain Dynamics

Pharmaceutical Distributors

Once manufactured, zuranolone’s distribution depends on regulatory approvals and drug commercialization pathways. The primary distribution channels include:

• Sage Therapeutics' Distribution Network: As the developer holding regulatory approval (pending or granted), Sage is likely to manage or oversee distribution agreements with major pharmaceutical distributors.

• Major Wholesalers: Companies like McKesson, Cardinal Health, and AmerisourceBergen may participate in the distribution once the drug is commercially available, ensuring broad access to healthcare providers.

Challenges in Supply Chain

• Regulatory Compliance: Stringent Good Manufacturing Practice (GMP) requirements influence supplier selection and quality assurance processes.

• Manufacturing Complexities: The steroid chemical synthesis involved in zuranolone production demands specialized facilities, which can cause potential bottlenecks.

• Global Supply Disruptions: Ongoing geopolitical tensions, supply chain disruptions, or raw material shortages (e.g., corticosteroid intermediates) could impact availability.

---

Future Outlook and Strategic Considerations

As zuranolone advances toward commercial launch, several dynamics will shape its supply chain:

• Scaling Up Production: Sage Therapeutics is anticipated to establish or expand manufacturing capacities, either through in-house facilities or strategic alliances, to meet anticipated demand.

• Partnership Growth: Collaborations with CMOs are likely to intensify, optimizing production efficiency and geographic reach.

• Supply Security Measures: Diversifying API sources and establishing safety stock levels will be critical to mitigate risk.

• Regulatory Coordination: Ensuring compliance across manufacturing sites will remain a top priority, especially in different jurisdictions.

---

Key Takeaways

• Sage Therapeutics currently leads zuranolone’s development and oversees its supply chain, with partnerships with specialized CMOs in chemical synthesis and formulation.

• API sourcing involves high-precision steroid chemistry, with potential involvement from global chemical suppliers, including companies in Asia and Europe.

• Commercial manufacturing is expected to be scaled up through a combination of in-house facilities and strategic CMO partnerships, aligning with regulatory and market demands.

• Supply chain resilience will be vital, requiring diversification and robust quality controls to navigate geopolitical and logistical challenges.

• Distribution channels are likely to involve major pharmaceutical distributors and wholesalers once the drug receives regulatory approval.

---

FAQs

1. When is zuranolone expected to receive regulatory approval?
Currently in late-stage clinical trials, Sage Therapeutics anticipates submission for approval in the near future, with regulatory decisions expected within 12-18 months, depending on trial outcomes and jurisdictional processes.

2. Which companies are most probable to be licensed suppliers of zuranolone API?
Leading global chemical manufacturers specializing in steroid synthesis, such as Evonik Industries or Asian chemical producers with steroid intermediate expertise, are potential candidates, though specific licensing agreements have not been publicly disclosed.

3. How does supply chain complexity affect zuranolone’s market introduction?
The intricate steroid chemistry and GMP requirements increase manufacturing complexity, potentially causing delays or shortages. The involvement of multiple CMOs and diversified sourcing strategies can mitigate these risks.

4. Will zuranolone be produced domestically in the U.S.?
While Sage has in-house capabilities, large-scale production is likely to be managed through strategic partnerships with international CMOs in countries with established steroid synthesis infrastructure to ensure cost efficiency and supply security.

5. What role do distributors play in zumanolone’s accessibility?
Distributors like McKesson and Cardinal Health will facilitate broad healthcare provider access post-approval, ensuring the drug's availability across hospitals, clinics, and pharmacies.

---

References

[1] Sage Therapeutics. (2022). Zuranolone Clinical Trial Disclosures.
[2] U.S. Food and Drug Administration. (2023). Guidance documents on steroid manufacturing and GMP.
[3] Industry Reports. (2022). Global API Manufacturing Landscape.
[4] Chemical Industry News. (2023). Steroid Intermediate Suppliers and Trends.
[5] MarketWatch. (2023). Major Distributors and Supply Chain Dynamics for Neuropsychiatric Drugs.