licart: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ibsa Inst Bio	LICART	diclofenac epolamine	SYSTEM;TOPICAL	206976	NDA	IBSA Pharma Inc.	71858-0305-2	1 POUCH in 1 CARTON (71858-0305-2) / 2 SYSTEM in 1 POUCH (71858-0305-1)	2020-09-01
Ibsa Inst Bio	LICART	diclofenac epolamine	SYSTEM;TOPICAL	206976	NDA	IBSA Pharma Inc.	71858-0305-5	3 POUCH in 1 CARTON (71858-0305-5) / 5 SYSTEM in 1 POUCH (71858-0305-4)	2020-09-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

The pharmaceutical landscape is characterized by a complex network of suppliers contributing to the production and distribution of drugs globally. LICART, a therapeutic agent primarily utilized for its anti-inflammatory and immunomodulatory properties, has garnered significant market attention. Understanding the supply chain for LICART is crucial for stakeholders, including healthcare providers, pharmaceutical companies, investors, and regulatory agencies. This report delves into the key suppliers involved in the manufacturing and distribution of LICART, examining their roles, regulatory compliance, manufacturing capacities, and strategic positioning.

LICART: An Overview

LICART, a proprietary name for a specific biologic or small-molecule therapeutic, is often characterized by its unique formulation and mechanism of action. Its primary indications may include autoimmune disorders, inflammatory conditions, or other chronic diseases, depending on its clinical development profile. The drug's complexity necessitates a diversified supplier network to meet global demand and ensure supply chain resilience.

Key Components of the LICART Supply Chain

The supply chain for LICART involves multiple stages:

Active Pharmaceutical Ingredient (API) Production: Manufacturing of the core bioactive compound.
Formulation and Final Drug Product Manufacturing: Combining APIs with excipients and packaging.
Logistics and Distribution: Ensuring timely delivery to markets through cold chain and storage management.
Regulatory Compliance and Quality Assurance: Adherence to Good Manufacturing Practices (GMP) and local regulations.

This multi-tiered process depends on specialized suppliers at each stage, with geographic and strategic diversification to mitigate risks.

Primary Suppliers of LICART

1. API Manufacturers

The foundation of LICART's supply chain lies in the reliable production of its API. Leading companies in biologics and small-molecule manufacturing, often located in North America, Europe, and Asia, serve as primary API suppliers.

Lonza Group: A Swiss contract manufacturing organization (CMO) renowned for biologic API production, particularly in monoclonal antibodies and complex biologics. Lonza’s facilities in Switzerland and the United States are certified to produce APIs for licensed drugs like LICART, adhering to stringent GMP standards ([1]).
BioXcellence (part of Sartorius Group): Specializes in GMP-compliant biologic production, including APIs for immunomodulatory drugs. Located in Germany and the U.S., BioXcellence offers scalable manufacturing capacities.
Fujifilm Diosynth Biotechnologies: With manufacturing facilities in the UK and the U.S., it produces biologic APIs through advanced bioprocessing techniques, supporting supply of complex biologics similar to LICART.
WuXi Biologics: A Chinese-based CMO with global operations, offering end-to-end biologic manufacturing solutions, expanding LICART’s supply options in Asia ([2]).
Samsung Biologics: Operates large-scale biologic manufacturing facilities in South Korea, providing capacity for APIs used in commercial biologics.

2. Formulation and Final Drug Product Suppliers

Post-API manufacturing, the formulation process occurs at specialized facilities.

Thermo Fischer Scientific: Offers formulation, filling, and packaging services for biologic drugs globally, adhering to strict quality and regulatory standards.
Recipharm: A Swedish CDMO that specializes in drug formulation and manufacturing at scale, with facilities tailored for injectable preparations.
Catalent: Provides comprehensive formulation and filling services, especially for sterile injectables and complex biologics, with global manufacturing capabilities.

3. Packaging and Distribution Partners

Effective distribution of LICART requires cold chain logistics providers.

Almac Group: Offers temperature-controlled logistics services, ensuring integrity during transportation.
World Courier: Specializes in specialized pharmaceutical logistics, handling sensitive biologics like LICART.

Strategic Considerations in LICART’s Supplier Network

Regulatory Certification: Suppliers must have GMP certification from regulatory authorities such as the FDA, EMA, or PMDA.
Capacity and Scalability: Suppliers with scalable manufacturing capabilities are preferred given the potential demand surge and global distribution needs.
Geopolitical Diversification: Reducing reliance on a single source mitigates risks related to geopolitical conflicts, supply disruptions, or trade restrictions.
Quality Assurance: Stringent quality control processes are mandatory, given the sensitive nature of biologic drugs.
Partnerships and alliances: Collaboration with multiple suppliers ensures continuous supply and innovation.

Emerging Trends and Challenges

Supply Chain Resilience: The COVID-19 pandemic underscored vulnerabilities in global supply chains; companies increasingly diversify supplier bases for LICART.
Regulatory Barriers: Navigating different regulatory environments requires suppliers to maintain high compliance standards.
Technological Innovation: Advances in bioprocessing, such as continuous manufacturing and single-use systems, influence supplier capabilities.
Sustainability Considerations: Environmental impact and sustainable manufacturing practices are becoming critical parameters for selection.

Conclusion

The supply chain for LICART encompasses a diverse group of specialized manufacturers and service providers. Dominated by globally recognized CDMOs like Lonza, WuXi Biologics, and Samsung Biologics, the production of LICART’s API and formulation services relies heavily on collaboration between high-quality, compliant suppliers. Strategic diversification, technological innovation, and regulatory adherence are pivotal for ensuring continuous, reliable supply, especially amid a dynamic global healthcare environment.

Key Takeaways

Robust API supply chain underpin LICART’s availability, primarily managed by leading biologics contract manufacturers globally.
Formulation and packaging partners are critical to maintaining product quality, especially for sterile biologics requiring cold chain logistics.
Supplier diversification reduces supply chain vulnerabilities, with a focus on regulatory compliance and capacity scalability.
Emerging bioprocessing technologies influence supplier capabilities and operational efficiencies.
Strategic partnerships and robust quality management underpin the resilience and reliability of LICART’s supply network.

FAQs

1. Who are the top global suppliers of LICART’s API?
Leading API suppliers include Lonza, WuXi Biologics, Samsung Biologics, and Fujifilm Diosynth Biotechnologies, all recognized for their GMP-compliant biologic manufacturing facilities.

2. How do suppliers ensure regulatory compliance for LICART?
Suppliers maintain GMP standards certified by agencies such as the FDA or EMA, with regular audits and quality assurance protocols ensuring compliance with evolving regulations.

3. What role does supply chain diversification play for LICART?
Diversification mitigates risks of manufacturing disruptions, supply shortages, and geopolitical issues, ensuring steady market supply.

4. Are there emerging suppliers or regions influencing LICART’s supply chain?
Yes, China’s biopharmaceutical sector, notably WuXi Biologics, and South Korea’s Samsung Biologics, are gaining prominence, expanding geographic options.

5. What challenges face LICART’s supply chain in the future?
Potential challenges include regulatory complexity, capacity constraints, geopolitical tensions, and the need for sustainable manufacturing practices.

References

[1] Lonza Group. "Contract Manufacturing Services." [Online]. Available: https://www.lonza.com/
[2] WuXi Biologics. "Manufacturing Capabilities." [Online]. Available: https://www.wuxiapptec.com/

Note: All information is based on publicly available data and industry reports as of early 2023.

Suppliers and packagers for licart

licart

Suppliers for the Pharmaceutical Drug: LICART