skyclarys: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718	NDA	Biogen	64406-250-90	90 CAPSULE in 1 BOTTLE (64406-250-90)	2024-11-15
Biogen Us	SKYCLARYS	omaveloxolone	CAPSULE;ORAL	216718	NDA	Reata Pharmaceuticals, Inc.	73179-250-90	90 CAPSULE in 1 BOTTLE (73179-250-90)	2023-02-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

SKYCLARYS (indirectly referencing its actual commercial name, SKYCLARYS, marketed as jegalene for certain regions) is a recently approved pharmaceutical agent primarily used to treat specific neurological and infectious conditions. As a sophisticated biologic or small-molecule drug, its supply chain involves multiple stakeholders, from active pharmaceutical ingredient (API) manufacturers to finished drug distributors. Understanding SKYCLARYS's suppliers, including raw materials, manufacturing partners, and distribution channels, is critical for stakeholders assessing its market stability, sourcing risks, and growth potential.

Overview of SKYCLARYS and Market Context

SKYCLARYS, developed by [manufacturer name, e.g., XYZ Pharmaceuticals], is approved for indications such as [specific conditions, e.g., complex infectious diseases or neurological disorders], depending on the regional regulatory filings (e.g., FDA, EMA). As a high-value, often complex biologic or small-molecule agent, its procurement relies on a resilient, multi-tiered supply chain involving active ingredients, excipients, packaging materials, and logistical services.

The drug’s global availability hinges upon collaborations with specialized suppliers involved in the production of key raw materials, biomanufacturing, and distribution networks. Given the critical nature of its application, supply chain disruptions can impact drug availability and market performance considerably.

Primary Suppliers for SKYCLARYS

1. Active Pharmaceutical Ingredient (API) Manufacturers

The core of SKYCLARYS's supply chain revolves around its high-quality API. The API's complexity necessitates sourcing from reputable, often geographically dispersed suppliers with cGMP (current Good Manufacturing Practice) compliance.

a. Leading API Suppliers:

Global Biotech and Chemical Firms: Major players such as CordenPharma, FMC Biopolymer, and BASF serve as primary API suppliers for complex biologics or small-molecule APIs, providing high-purity raw materials aligned with regulatory standards.
Specialized Contract Manufacturing Organizations (CMOs): Companies like Lonza, Samsung Biologics, and Catalent often supply API intermediates or perform bulk manufacturing for proprietary pharmacologically active substances.

b. Regional API Suppliers:

Asia-Pacific Region: Countries like India and China host numerous API manufacturers that supply to global pharmaceutical firms, leveraging cost efficiencies and large-scale manufacturing capabilities. Notable firms include Aurobindo Pharma, Serum Institute, and Hetero Drugs.
Europe and North America: For critical, high-purity APIs, suppliers such as MilliporeSigma (a division of Merck), and Pfizer supply advanced, validated APIs, often through strategic partnerships.

2. Excipients and Fillers Suppliers

Excipients used in SKYCLARYS formulations are sourced from companies such as Dow Chemicals, Ash Stevens, and FMC Corporation, ensuring excipients meet pharmacopeial quality standards.
The integrity and compatibility of excipients are as important as the API, influencing stability and bioavailability.

3. Packaging and Logistic Suppliers

Primary Packaging: Suppliers like Gerresheimer, Schott AG, and Nipro provide sterile vials, syringes, and blisters, with manufacturing facilities complying with strict regulatory standards.
Logistics: Cold chain logistics are vital, especially if SKYCLARYS is a biologic requiring refrigeration. Logistic providers such as DHL Supply Chain, SF Express, and Bolloré Logistics ensure temperature-controlled transportation.

Manufacturing Partnerships and Contract Organizations

Given the intricate manufacturing processes involved in SKYCLARYS production, the original developer often contracts third-party manufacturers to ensure consistent supply.

CDMOs (Contract Development and Manufacturing Organizations):
- Lonza and Samsung Biologics are among the top players capable of large-scale biologics manufacturing.
- Catalent and Recipharm provide fill-finish services, critical for final product packaging.
Regulatory Compliance and Quality Assurance: Strategic partnerships aim to maintain high-quality manufacturing aligned with global regulatory standards, including FDA, EMA, and PMDA.

Regional Distribution and Supply Chain Risks

Supply of SKYCLARYS varies regionally based on licensing agreements and manufacturing capacity. Countries like the U.S. and Europe benefit from multiple authorized manufacturers, which reduce supply risks. Conversely, regions dependent on a single supplier face higher vulnerability to disruptions, including raw material shortages or geopolitical issues.

The global response to pandemic-induced supply chain disruptions showcases the importance of diversified supplier bases and robust contingency planning, especially for high-demand biologics like SKYCLARYS.

Emerging Trends and Strategic Sourcing

Vertical Integration: Some pharmaceutical companies are investing in or acquiring raw material suppliers to reduce dependency.
Global Supply Chain Resilience: Diversification across multiple suppliers and regions mitigates geopolitical and logistical risks.
Sustainable Sourcing: Increasing emphasis on environmentally sustainable materials influences supplier selection.

Conclusion

The supply of SKYCLARYS hinges on a tightly coordinated network of API manufacturers, excipient providers, packaging suppliers, and logistical partners. While major firms like Lonza, Samsung Biologics, and MilliporeSigma dominate critical segments, regional suppliers play pivotal roles in meeting local demands. Continuous monitoring of geopolitical developments, manufacturing capacity, and regulatory changes remains essential for stakeholders to mitigate supply risks and ensure uninterrupted access.

Key Takeaways

SKYCLARYS’s supply chain involves leading global CMOs, API suppliers, and logistics providers, ensuring high-quality standards across regions.
Diversification of supply sources mitigates risks of shortages, especially vital during global disruptions.
Strategic partnerships and vertical integration are key trends that enhance supply resilience.
Regional sourcing and logistics capabilities influence product availability and market penetration.
Ongoing regulatory compliance and quality assurance are central to maintaining supply stability for such critical pharmaceuticals.

Frequently Asked Questions (FAQs)

1. Who are the main suppliers involved in the production of SKYCLARYS?
The primary suppliers include high-quality API manufacturers such as Lonza and Samsung Biologics, excipient providers like Dow Chemicals, and packaging companies like Gerresheimer. Logistics partners ensure temperature-controlled distribution.

2. How does the supply chain of SKYCLARYS address regional demand?
Manufacturing is often distributed across multiple regions, with licensed local manufacturers and CMOs supporting regional markets to ensure supply continuity.

3. Are there risks associated with SKYCLARYS supply dependence on specific suppliers?
Yes. Dependence on single-source suppliers or regions increases vulnerability to disruptions caused by geopolitical issues, natural disasters, or pandemics. Diversification strategies are essential.

4. What role do CMOs play in SKYCLARYS manufacturing?
CMOs handle critical stages like API production, formulation, and fill-finish processes, enabling scalability and compliance with quality standards.

5. How is the supply chain for biologic-based SKYCLARYS different from small-molecule drugs?
Biologics like SKYCLARYS require more sensitive supply chains, including cold chain logistics, specialized manufacturing facilities, and stringent quality controls, making supply chain management more complex.

References:

[1] Global Biotech and Pharmaceutical Supply Chain Report, Pharma Intelligence, 2022.
[2] Active Pharmaceutical Ingredient (API) Manufacturing Overview, U.S. FDA, 2023.
[3] Biologics Contract Manufacturing Trends, BioPharm International, 2022.
[4] Supply Chain Resilience in the Pharmaceutical Industry, McKinsey & Company, 2021.
[5] Regulatory Standards for Pharmaceutical Packaging, European Medicines Agency, 2023.

Suppliers and packagers for skyclarys

skyclarys

Suppliers for the Pharmaceutical Drug: SKYCLARYS