Share This Page
Suppliers and packagers for spravato
✉ Email this page to a colleague
spravato
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | SPRAVATO | esketamine hydrochloride | SPRAY;NASAL | 211243 | NDA | Janssen Pharmaceuticals Inc. | 50458-028-02 | 2 BLISTER PACK in 1 KIT (50458-028-02) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00) | 2019-03-05 |
| Janssen Pharms | SPRAVATO | esketamine hydrochloride | SPRAY;NASAL | 211243 | NDA | Janssen Pharmaceuticals Inc. | 50458-028-03 | 3 BLISTER PACK in 1 KIT (50458-028-03) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00) | 2019-03-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Spravato
Introduction
Spravato (esketamine) has revolutionized depression treatment, providing a novel approach for patients with treatment-resistant depression (TRD). As a recently approved nasal spray by the FDA, its unique formulation and production requirements position its suppliers as critical players in the pharmaceutical supply chain. This article examines the key suppliers involved in Spravato’s development, manufacturing, and distribution, offering insights for stakeholders and investors seeking to understand its supply ecosystem.
Overview of Spravato (Esketamine)
Spravato is a nasal spray containing esketamine, the S-enantiomer of ketamine. Approved in March 2019, it is indicated for adults with TRD and is administered alongside oral antidepressants. Due to its novel mechanism targeting NMDA receptors, esketamine’s production involves specialized synthesis and stringent quality controls, making supplier selection pivotal.
Key Components and Supply Chain for Spravato
Active Pharmaceutical Ingredient (API): Esketamine
Esketamine’s API is central to Spravato. Its production demands advanced chemical synthesis techniques, high purity standards, and robust quality assurance.
- Main API Manufacturers:
- Jubilant Life Sciences (India)
- Hovione (Portugal)
- Fuji Film Toyama Chemical Co., Ltd. (Japan)
These firms are equipped with specialized facilities for chiral synthesis, given the stereospecific nature of esketamine. The API suppliers typically operate under stringent Good Manufacturing Practices (GMP) to meet regulatory standards and ensure safety.
- Supply Chain Considerations:
- The API suppliers often produce esketamine in multi-ton quantities to accommodate global supply needs.
- Due to high stereospecific purification requirements, API yields are carefully monitored, and supply contracts are often long-term to ensure stability.
Excipient and Formulation Components
Apart from the API, Spravato’s nasal spray formulation includes excipients such as preservatives, stabilizers, and solvents.
- Suppliers for Excipients:
- BASF (Germany)
- Dow Chemical (USA)
- Shin-Etsu Chemical (Japan)
These ingredients are sourced globally, adhering to pharmacopoeial standards to ensure compatibility and safety in nasal delivery.
Nasal Delivery Device Manufacturers
The precision and reliability of Spravato’s nasal spray device are critical, given the drug’s required dosing accuracy and administration.
- Primary Device Suppliers:
- Meda Pharma (France)
- Viatris (USA)
- Stryker (USA)
- Gerresheimer (Germany)
These firms supply nasal spray applicators designed specifically for Spravato, with considerations for minimal drug loss, user safety, and ease of administration.
Manufacturing and Packaging
Pharmaceutical contract manufacturing organizations (CMOs) are integral to the production of Spravato.
- Notable CMOs involved:
- Catalent (USA)
- Lonza (Switzerland)
- Recipharm (Sweden)
These organizations oversee formulation, filling, granulation, and final packaging, ensuring compliance with GMP standards and facilitating rapid scaling to meet global demand.
Packaging, including immediate and secondary packaging materials such as blister packs, cartons, and labeling, are supplied by specialized pharmaceutical packaging firms, including Gerresheimer and Albéa.
Distribution and Logistics
The supply chain extends to distribution hubs across continents, ensuring timely delivery to healthcare providers.
- Major Distribution Partners:
- McKesson (USA)
- AmerisourceBergen (USA)
- Alliance Healthcare (Europe)
Cold chain logistics and temperature-sensitive handling are essential, given esketamine’s stability profile, positioning specialized logistics providers as critical supply chain nodes.
Regulatory and Quality Standards
Suppliers across all stages – API manufacturing, excipients, device production, and distribution – must adhere to global regulatory standards, including:
- FDA GMP compliance
- EMA standards (Europe)
- ICH guidelines for stability and quality
Any disruption or quality issue in the supply chain can impact availability, regulatory approval, and market confidence.
Market Implications for Suppliers
The limited number of specialized API manufacturers and device suppliers consolidates market power among few firms, which influences pricing and contractual negotiations. As demand for Spravato rises, supply chain resilience and capacity expansion become crucial factors.
Furthermore, ongoing patent protections and potential biosimilar development could reshape supplier dynamics, requiring continuous market monitoring.
Conclusion
Spravato’s supply chain is characterized by a tight network of high-specification API producers, excipient providers, device manufacturers, and logistics providers, all operating under rigorous regulatory standards. The complexity and specialization inherent in esketamine’s production make supplier expertise and capacity critical for ensuring uninterrupted availability. As usage expands globally, strategic partnerships and investments in supply chain resilience will drive the drug’s market stability and growth.
Key Takeaways
- Limited but specialized API suppliers dominate Spravato’s production, with firms like Jubilant, Hovione, and Fuji Film leading the market.
- Device manufacturers ensure precise nasal spray delivery, with firm-specific innovations underscoring sterility and usability.
- Contract manufacturing organizations manage formulation, packaging, and logistics, necessitating high compliance with GMP standards.
- Supply chain resilience is vital as increased demand could strain existing capacity, influencing pricing and access.
- Regulatory adherence remains paramount, with all suppliers needing to meet stringent standards to prevent disruptions.
FAQs
-
Who are the primary API suppliers for Spravato?
Jubilant Life Sciences, Hovione, and Fuji Film Toyama Chemical are the leading API producers, specializing in stereospecific esketamine synthesis. -
What role do device manufacturers play in Spravato’s supply chain?
They produce precision nasal spray applicators tailored for Spravato, ensuring correct dosing and ease of use, critical for patient safety. -
Are there any risks associated with the supply chain of Spravato?
Yes. The reliance on a limited number of specialized API producers, regulatory compliance issues, and logistical challenges could impact product availability. -
How does regulatory compliance affect suppliers?
Suppliers must adhere to GMP and other international standards, ensuring consistent quality to meet FDA, EMA, and other global regulatory requirements. -
What is the outlook for supplier consolidation in the Spravato market?
Given the technical complexity, market consolidation may increase, with existing suppliers strengthening their positions or new entrants focusing on API synthesis and device innovation.
References
[1] Food and Drug Administration. (2019). FDA approves new nasal spray medication for treatment-resistant depression.
[2] Hovione. Official Website. — Suppliers for pharmaceutical APIs.
[3] Jubilant Life Sciences. Corporate Overview.
[4] Stryker. Product information.
[5] European Medicines Agency. GMP guidelines and standards.
More… ↓
