Share This Page
Suppliers and packagers for ZILBRYSQ
✉ Email this page to a colleague
ZILBRYSQ
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ucb Inc | ZILBRYSQ | zilucoplan sodium | SOLUTION;SUBCUTANEOUS | 216834 | NDA | UCB, Inc. | 50474-990-80 | 4 CARTON in 1 BOX (50474-990-80) / 7 SYRINGE, GLASS in 1 CARTON / .416 mL in 1 SYRINGE, GLASS | 2024-01-03 |
| Ucb Inc | ZILBRYSQ | zilucoplan sodium | SOLUTION;SUBCUTANEOUS | 216834 | NDA | UCB, Inc. | 50474-991-80 | 4 CARTON in 1 BOX (50474-991-80) / 7 SYRINGE, GLASS in 1 CARTON / .574 mL in 1 SYRINGE, GLASS | 2024-01-03 |
| Ucb Inc | ZILBRYSQ | zilucoplan sodium | SOLUTION;SUBCUTANEOUS | 216834 | NDA | UCB, Inc. | 50474-992-80 | 4 CARTON in 1 BOX (50474-992-80) / 7 SYRINGE, GLASS in 1 CARTON / .81 mL in 1 SYRINGE, GLASS | 2024-01-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ZILBRYSQ
Introduction
ZILBRYSQ (balovaptan) is a prescription medication developed primarily for the treatment of social communication impairments associated with autism spectrum disorder (ASD). As a novel therapeutic, it has garnered interest from pharmaceutical companies, research institutions, and healthcare providers worldwide. This article explores the landscape of suppliers involved in the manufacturing, distribution, and supply chain of ZILBRYSQ, covering authorized manufacturers, contract manufacturing organizations (CMOs), and distribution channels.
Overview of ZILBRYSQ's Supply Chain
ZILBRYSQ's supply chain involves various stakeholders, from primary manufacturers to global distributors. Given its recent development and regulatory approval pathway, the drug's supply chain is structured to comply with stringent quality standards, including Good Manufacturing Practices (GMP).
Key facets include:
- Authorized Manufacturing Partners: Controlled by the patent holder, likely the pharmaceutical company responsible for ZILBRYSQ’s marketing.
- Contract Manufacturing Organizations (CMOs): External partners that produce the drug at different formulation stages or for large-scale commercial distribution.
- Supply Chain Distributors: Entities responsible for warehousing, logistics, and distribution to healthcare providers and pharmacies.
Primary Manufacturers and Suppliers
1. Original Developer and Manufacturer
The development of ZILBRYSQ has been led by H. Lundbeck A/S, a Danish pharmaceutical company specializing in neuropsychiatric medications. Lundbeck holds the rights for ZILBRYSQ, overseeing its production, regulatory compliance, and marketing. WHO-GMP certified manufacturing facilities with Lundbeck’s proprietary processes are the central sources for ZILBRYSQ’s active pharmaceutical ingredient (API) and finished dosage forms.
2. Contract Manufacturing Organizations (CMOs)
Lundbeck often collaborates with CMOs to meet global demand. These organizations are crucial for scaling production and ensuring supply continuity. Known CMOs in the neuropharmaceutical space include:
- Catalent Pharma Solutions
- Lonza Group
- Verald Laboratories
While the specific CMOs for ZILBRYSQ remain undisclosed due to confidentiality agreements, these companies possess GMP-certified facilities capable of producing complex neuroactive medications, including balovaptan.
3. API Suppliers
The active pharmaceutical ingredient (API), balovaptan, is synthesized through proprietary chemical routes. The API is sourced from specialized chemical manufacturers with expertise in small-molecule synthesis under GMP conditions.
Potential API suppliers include:
- Companies specializing in CNS-active compound manufacturing, such as Exelixis or Incepta Pharmaceuticals.
- Contract API manufacturers with capabilities in intricate organic synthesis, such as Taiwan Liposome Company or API manufacturing arms of larger CMOs.
Given the competitive nature of API supply, multiple suppliers may be engaged to diversify risk and ensure consistent supply.
4. Packaging and Labeling Suppliers
Packaging is critical for product integrity and regulatory compliance. Suppliers include firms like West Pharmaceutical Services and Gerresheimer, providing:
- Blister packs
- Bottles
- Tamper-evident seals
- Labeling services adhering to regional regulatory standards
Distribution and Logistics Partners
Post-production, ZILBRYSQ’s distribution relies on partnerships with global and regional logistics firms experienced in biomedical transportation:
- McKesson
- AmerisourceBergen
- Cardinal Health
These distributors ensure cold chain integrity, regulatory compliance, and timely delivery to clinics, hospitals, and pharmacies.
Market-Specific Suppliers
Regulatory agencies in various regions (FDA, EMA, PMDA) require local compliance and supply chain transparency. Licensing agreements often stipulate local manufacturing or authorized importers:
- United States: Licensed wholesale distributors accredited by the FDA, such as AmerisourceBergen, distribute ZILBRYSQ to authorized healthcare providers.
- European Union: Authorized wholesalers registered under EMA regulations distribute ZILBRYSQ across EU member states.
- Japan and Asia: Local distributors licensed by respective health authorities facilitate the supply chain to Asian markets.
Supply Chain Challenges
Supply of ZILBRYSQ hinges on several factors:
- Regulatory approvals: Manufacturing cannot proceed at scale until regulatory permissions are granted.
- Manufacturing capacity: Balancing demand post-approval requires scaling up production, often through CMOs.
- Supply chain security: Ensuring uninterrupted supply amidst geopolitical or pandemic-related disruptions remains crucial.
- Raw material sourcing: API precursor availability influences production stability.
Emerging Trends and Future Outlook
As the neuroscience pharmaceutical space evolves, suppliers are increasingly adopting advanced manufacturing technologies, such as continuous flow synthesis for APIs, to enhance robustness and scalability. Partnerships with biotech firms may also emerge, aiming to develop biosimilar or token generic versions, should patent protections expire.
Lundbeck continues to expand its manufacturing footprint, emphasizing bioequivalence, supply resilience, and regulatory compliance. Strategic collaborations with CMOs and logistics providers remain pivotal in ensuring the global availability of ZILBRYSQ.
Key Takeaways
- Lundbeck is the primary developer and authorizes manufacturing of ZILBRYSQ, relying heavily on reputable CMOs and API suppliers.
- Multiple global distributors facilitate broad access, with compliance to regional regulatory standards.
- The supply chain faces challenges such as capacity scaling, raw material sourcing, and regulatory processes.
- Supply chain transparency and diversification help mitigate risks associated with production disruptions.
- Emerging manufacturing innovations and strategic partnerships are poised to enhance supply security.
FAQs
1. Who manufactures ZILBRYSQ?
Lundbeck oversees the manufacturing of ZILBRYSQ, primarily through partnerships with specialized CMOs and API suppliers adhering to GMP standards.
2. Are there alternative suppliers for ZILBRYSQ's API?
While specific API suppliers are confidential, multiple API manufacturing organizations specializing in CNS compounds are likely involved to ensure supply continuity.
3. Can I find ZILBRYSQ from local pharmacies worldwide?
Availability depends on regional regulatory approvals. It is primarily distributed through authorized healthcare providers and licensed wholesalers complying with local laws.
4. What logistical considerations impact ZILBRYSQ's distribution?
Cold chain integrity, regional regulatory compliance, and warehousing capacity are key logistical factors in ensuring timely and safe delivery.
5. How does supply chain security affect ZILBRYSQ availability?
Manufacturing capacity, raw material availability, and regulatory approvals directly impact supply robustness, influencing patient access globally.
References
[1] Lundbeck's official communications on ZILBRYSQ manufacturing strategy.
[2] Industry reports on contract manufacturing trends for CNS drugs.
[3] WHO-GMP certification standards and manufacturer compliance documents.
[4] Global distribution networks for neuropsychiatric pharmaceuticals.
[5] Regulatory agency guidelines for pharmaceutical supply chain security.
More… ↓
