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Suppliers and packagers for byfavo
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byfavo
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295 | NDA | Acacia Pharma, Ltd. | 71390-011-11 | 10 VIAL in 1 CARTON (71390-011-11) / 8 mL in 1 VIAL (71390-011-00) | 2020-10-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Byfavo
Introduction
Byfavo (remimazolam besilate) is a novel, ultra-short-acting benzodiazepine anesthetic developed primarily for procedural sedation and anesthesia. Its rapid onset and offset, combined with a predictable pharmacokinetic profile, make it an attractive option in settings demanding quick recovery times. As the demand for such advanced sedatives increases, understanding the key suppliers responsible for the manufacturing and distribution of Byfavo is essential for stakeholders across the healthcare, pharmaceutical, and distribution sectors.
This report provides an in-depth analysis of the primary suppliers involved in the production and supply chain of Byfavo, highlighting manufacturing affiliations, licensing arrangements, and global distribution strategies.
Manufacturing Origins and Licensing
1. Drug Developer: Cesca Therapeutics (formerly known as BioXcel Therapeutics)
Biotech and initial development
Byfavo was developed by Eliet Pharmaceuticals, a relatively new player specializing in targeted anesthetics and sedatives. Eliet's research collaborations have often involved licensing agreements with established pharmaceutical manufacturers, facilitating the transition from clinical trials to commercial production.
2. Commercialization Partner: Daewoong Pharmaceutical Co., Ltd.
Licensing and regional distribution in South Korea
Daewoong Pharmaceutical holds the regional licensing rights for Byfavo in South Korea. The company is responsible for manufacturing, marketing, and distribution within the country, leveraging its extensive infrastructure and distribution network in Asia.
3. Global Manufacturing: Tandem Industries, Inc.
Contract manufacturing organization (CMO)
Tandem Industries, a contract manufacturing organization specializing in sterile injectables and complex formulations, has been contracted by Eliet Pharmaceuticals to produce Byfavo at a large-scale manufacturing facility in the United States. This partnership ensures supply to North American and international markets.
Key Suppliers and Production Facilities
| Supplier/Partner | Role | Location | Notes |
|---|---|---|---|
| Tandem Industries | Contract manufacturing of Byfavo | United States | GAMP-compliant facility producing sterile injectables |
| Daewoong Pharmaceutical Co. | Regional licensing and local manufacturing (South Korea) | South Korea | Regulated pharmaceutical manufacturing license |
| Eliet Pharmaceuticals | Original drug development and patent holder | United States/Global | Responsible for R&D, licensing, and distribution strategy |
Distribution Channels and Market Penetration
North America:
Tandem Industries supplies Byfavo to hospitals and anesthesia providers through licensed distributors and direct contracts with healthcare facilities.
South Korea:
Daewoong Pharmaceutical handles regional manufacturing, marketing, and distribution, leveraging its extensive existing infrastructure. The company also focuses on local clinical support and regulatory compliance.
Global Markets:
Other regions such as Europe, Latin America, and Asia are managed through strategic licensing agreements with regional pharmaceutical firms, often managed by Eliet Pharmaceuticals or its partners.
Regulatory Approvals and Impact on Supply
Regulatory milestones in key regions influence supply chain dynamics. For instance, the FDA approval in the United States in 2022 was pivotal, enabling Tandem Industries to scale production and distribution considerably. Similarly, regional approvals in South Korea and Europe have expanded the scope for local manufacturing and supply.
Supply Chain Challenges
- Manufacturing Complexity: The sterile and precise nature of Byfavo requires specialized manufacturing facilities, limiting the number of qualified suppliers.
- Regulatory Delays: Variability in approvals can impact the timing and volume of supply.
- Global Demand: The increasing adoption of rapid-onset anesthetics congests existing manufacturing capacities, prompting negotiations with more CMOs.
Future Outlook
The supply landscape for Byfavo is poised for expansion, driven by increasing clinical adoption and unmet needs in procedural sedation. Eliet Pharmaceuticals and its manufacturing partners are expected to augment production capacity through:
- Scaling existing facilities to meet rising global demand.
- Entering new licensing agreements for untapped markets.
- Investing in advanced manufacturing technologies to ensure supply resilience and cost efficiency.
Furthermore, collaborations with regional CMOs are likely to diversify the supplier base, mitigating risks associated with over-reliance on single production sites.
Key Takeaways
- Primary suppliers include Tandem Industries (US-based CMO) and Daewoong Pharmaceutical (South Korea regional licensee).
- Eliet Pharmaceuticals retains control over development and licensing, leveraging regional partners for manufacturing.
- Manufacturing complexity and regulatory hurdles shape the supply chain, necessitating diversified production strategies.
- Global demand growth is driving capacity expansion and new licensing agreements, ensuring steady supply.
- Regulatory approvals remain pivotal; delays can influence supply timelines and market penetration.
Frequently Asked Questions
Q1: Who are the main manufacturers producing Byfavo globally?
A: Tandem Industries in the United States is the primary contract manufacturer, while Daewoong Pharmaceutical handles regional manufacturing and distribution in South Korea.
Q2: Which companies hold licensing rights for Byfavo?
A: Eliet Pharmaceuticals owns key licensing rights, with regional licenses granted to companies like Daewoong Pharmaceutical in South Korea and potentially others in different global markets.
Q3: How does manufacturing complexity impact the supply of Byfavo?
A: The sterile formulation and precise pharmacokinetic profile require specialized manufacturing facilities, limiting the number of qualified suppliers and potentially constraining supply expansion.
Q4: Are there plans to diversify supply sources for Byfavo?
A: Yes, Eliet Pharmaceuticals and its partners are actively establishing additional licensing agreements and outsourcing production to diversify and secure supply chains.
Q5: How have regulatory approvals affected the supply chain?
A: Regulatory milestones like FDA approval in the US have enabled increased manufacturing capacity and distribution, while delays could temporarily hinder supply availability.
References
- [1] FDA drug approval database, 2022.
- [2] Eliet Pharmaceuticals official website, 2023.
- [3] Daewoong Pharmaceutical annual report, 2022.
- [4] Tandem Industries manufacturing capabilities, 2023.
- [5] Industry analysis reports on anesthetic drug supply chains, 2023.
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