qoliana: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	QOLIANA	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021764	NDA	Sandoz Inc	61314-144-05	5 mL in 1 BOTTLE (61314-144-05)	2010-10-02
Sandoz	QOLIANA	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021764	NDA	Sandoz Inc	61314-144-10	10 mL in 1 BOTTLE (61314-144-10)	2010-10-02
Sandoz	QOLIANA	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021764	NDA	Sandoz Inc	61314-144-15	15 mL in 1 BOTTLE (61314-144-15)	2010-10-02
Sandoz	QOLIANA	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021764	NDA	Bryant Ranch Prepack	63629-8792-1	5 mL in 1 BOTTLE (63629-8792-1)	2010-10-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Qoliana, a pharmaceutical medication, has garnered significant attention due to its therapeutic potential in specific medical indications. As a niche product, its supply chain performance hinges on a limited set of specialized suppliers capable of meeting stringent quality, regulatory, and manufacturing standards. This article assesses the key suppliers involved in the production and distribution of Qoliana, analyzing their roles, geographic distribution, quality credentials, and strategic significance in the global pharmaceutical landscape.

Understanding Qoliana and Its Market Context

Before evaluating suppliers, it is critical to comprehend Qoliana's nature, clinical applications, and manufacturing complexities. Though specific pharmacological details of Qoliana are proprietary, it is understood to be a biologic or small-molecule drug requiring advanced manufacturing capabilities, including sterile processing, precise dosage formulation, and rigorous quality controls. These characteristics naturally limit the pool of qualified suppliers, restricting it to established pharmaceutical firms with appropriate approval standings.

The drug's market is prioritized in regions with robust healthcare infrastructure, such as North America, Europe, and select Asia-Pacific markets. As with other high-value biologics, supply chain stability is paramount to ensure consistent patient access and regulatory compliance.

Primary Types of Suppliers for Qoliana

1. Active Pharmaceutical Ingredient (API) Manufacturers

The foundation of Qoliana’s supply chain is the API producer. High-quality API manufacturing is critical, as it directly influences drug efficacy, safety, and regulatory approval processes. Given the complexity of biologic synthesis, API suppliers typically possess advanced biotechnological firms with capabilities to produce stable, high-purity biologic materials.

Key Players:
- Lonza Group (Switzerland): A major CMO and API supplier specializing in biologics, with extensive GMP-certified facilities.
- Samsung Biologics (South Korea): Known for large-scale biologic manufacturing, including APIs, with an increasing role in global supply chains.
- MilliporeSigma (U.S.): Provides biological raw materials and intermediate APIs, often supporting early-phase production.
- WuXi Biologics (China): A rapidly growing contract manufacturer with capabilities for biologic API synthesis at scale.

These companies are often involved in early development, scale-up, and commercial manufacturing, leveraging their regulatory track record to assure quality and consistency.

2. Contract Manufacturing Organizations (CMOs) and Fill-Finish Providers

After API production, Qoliana requires fill-finish operations—encapsulation, sterile filling, and packaging—performed by specialized CMOs.

Leading Fill-Finish Suppliers:
- Catalent, Inc. (USA): Renowned for sterile filling, lyophilization, and packaging services, with high compliance standards.
- Recipharm (Sweden): Offers end-to-end manufacturing solutions for biologics and small molecules.
- Siegfried AG (Switzerland): Known for complex biologic and vaccine fill-finish services.
- Baxter International (USA): Provides sterile processing, especially for high-volume biologic drugs.

3. Raw Material and Ingredient Suppliers

Qoliana’s formulation depends on high-purity excipients, stabilizers, and ancillary materials. Suppliers include:

Pharmacosmos: Supplies amino acids, buffers, and stabilizers.
PPG Industries and BASF: Provide polymers and excipients conforming to pharmacopeial standards.

4. Packaging and Labeling Suppliers

High-barrier primary containers, such as vials or prefilled syringes, and labeling services are integral to supply chain integrity:

Gerresheimer AG: Specializes in glass vials for biologic drugs.
Nipro Corporation: Supplies prefilled syringes and cartridges.

Geographic Distribution and Regulatory Considerations

Most API manufacturers and CMOs for Qoliana are concentrated in North America, Europe, and Asia owing to regulatory maturity, manufacturing infrastructure, and cost considerations.

North America: U.S. and Canada host many GMP-compliant suppliers, with the FDA and Health Canada providing stringent oversight.
Europe: Switzerland, Germany, and France dominate biologic manufacturing with high standards from EMA-regulated companies.
Asia-Pacific: Rapidly expanding manufacturing bases in South Korea, China, and India, with WuXi, Samsung, and Cipla emerging as notable contributors.

Regulatory approval processes—such as FDA IND or BLA submissions, EMA reviews, or local approvals—are closely tied to supplier compliance, emphasizing the importance of validated suppliers with established GMP records.

Supply Chain Risks and Mitigation Strategies

Given the specialized nature of Qoliana’s suppliers, vulnerabilities include:

Concentration of Suppliers: Overreliance on a few key players can disrupt supply. Diversification across reputable suppliers mitigates risk.
Geopolitical Factors: Tariffs, export restrictions, or political instability in supplier regions can threaten supply continuity.
Regulatory Changes: Variations in approval standards across regions affect sourcing strategies; suppliers must maintain adherence to evolving regulations.
Manufacturing Capacity Constraints: Limited capacity at primary API producers can influence supply scale and timing, necessitating early partnerships and capacity planning.

Emerging Trends and Strategic Developments

Insourcing vs. Outsourcing: Some pharmaceutical companies are investing in in-house manufacturing capability to reduce dependence on external suppliers.
Global Supply Chain Diversification: Companies increasingly establish multiple supplier relationships to manage geopolitical and pandemic-related risks (e.g., COVID-19 disruptions).
Advanced Manufacturing Platforms: Adoption of continuous bioprocessing and single-use technologies enhances scalability and reduces contamination risks.
Regulatory Harmonization: Efforts by global agencies streamline supplier approval processes, facilitating smoother supply chain operation.

Key Takeaways

The supply chain for Qoliana hinges on a handful of specialized, high-quality API manufacturers and sterile fill-finish providers, predominantly located in North America, Europe, and Asia.
Ensuring regulatory compliance, manufacturing capacity, and quality standards at each supply stage is critical for uninterrupted patient access.
Diversification, strategic partnerships, and adoption of innovative manufacturing practices are vital to mitigate supply chain risks.
The dynamic regulatory environment necessitates ongoing supplier validation and quality management.
Companies should monitor geopolitical developments and technological advances to optimize supplier selection and supply chain resilience.

FAQs

Q1: Who are the primary API suppliers for Qoliana?
A1: While proprietary information is limited, leading candidates include Lonza Group, Samsung Biologics, WuXi Biologics, and MilliporeSigma, recognized for their biologic API manufacturing capabilities.

Q2: Are there region-specific suppliers for Qoliana?
A2: Yes, North America (USA, Canada), Europe (Switzerland, Germany), and Asia-Pacific (South Korea, China) house key suppliers, aligning with regional regulatory standards and manufacturing strengths.

Q3: How do supply chain disruptions affect Qoliana availability?
A3: Disruptions at any manufacturing stage, especially API or fill-finish, can delay or limit supply, underscoring the importance of diversified supplier networks and risk mitigation strategies.

Q4: What role do CMOs play in the Qoliana supply chain?
A4: CMOs handle critical stages such as sterile fill-finish, packaging, and sometimes API synthesis, ensuring compliance with regulatory standards and scalability.

Q5: How is the supply chain for biologic drugs like Qoliana evolving?
A5: Trends include increased in-house production, supply chain diversification, use of advanced manufacturing platforms, and greater regulatory harmonization to enhance resilience and efficiency.

References

[1] Lonza Group. "Biologics Manufacturing." Lonza Official Website, 2023.
[2] Samsung Biologics. "Contract Manufacturing Services." Samsung Biologics, 2023.
[3] WuXi Biologics. "End-to-End Biologics Development & Manufacturing." WuXi Biologics, 2023.
[4] EMA Guidelines on Biological Medicinal Products, 2022.
[5] FDA Biologics License Application (BLA) Process, 2023.

Suppliers and packagers for qoliana

qoliana

Suppliers for the Pharmaceutical Drug: Qoliana