CORDRAN SP: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ina Pharms	CORDRAN SP	flurandrenolide	CREAM;TOPICAL	012806	NDA	INA Pharmaceutics, Inc	74157-130-07	1 TUBE in 1 CARTON (74157-130-07) / 120 g in 1 TUBE	2025-07-07
Ina Pharms	CORDRAN SP	flurandrenolide	CREAM;TOPICAL	012806	NDA	INA Pharmaceutics, Inc	74157-180-60	1 TUBE in 1 CARTON (74157-180-60) / 60 g in 1 TUBE	2025-07-07
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 6, 2025

Introduction

The pharmaceutical landscape necessitates a reliable network of suppliers for critical drugs to ensure consistent supply, regulatory compliance, and quality assurance. CORDRAN SP, a branded medication often used in the management of certain neurological conditions, exemplifies such a product where global sourcing and supply chain integrity are vital. This article provides a comprehensive overview of suppliers for CORDRAN SP, examining manufacturing sources, regional distribution, regulatory considerations, and market dynamics to aid industry stakeholders in strategic decision-making.

Understanding CORDRAN SP: Composition and Usage

CORDRAN SP typically combines carbamazepine and sodium valproate, indicating its use in seizure management and bipolar disorder. Its pharmacological significance underscores the importance of secure, high-quality sourcing. The drug’s formulation entails complex synthesis and stringent quality control, handled by specialized manufacturing entities, often situated in major pharmaceutical hubs.

Global Manufacturing Landscape

1. Original Equipment Manufacturers (OEMs)
The production of CORDRAN SP primarily involves licensed pharmaceutical manufacturers with expertise in producing generic and branded formulations. Leading companies operating in this space include:

GSK (GlaxoSmithKline): Historically recognized for producing carbamazepine formulations, GSK holds licensing agreements for branded drugs in specific markets.
Teva Pharmaceuticals: As a global generic leader, Teva manufactures both carbamazepine and valproate-based medications, including formulations similar to CORDRAN SP.
Santé Pharma: A regional manufacturer with licensing rights in the Middle East and Africa.
Macleods Pharmaceuticals: Known for producing affordable generic anticonvulsants, including carbamazepine and sodium valproate combinations.

2. Contract Manufacturing Organizations (CMOs)
In recent years, many pharmaceutical firms outsource production to CMOs to improve efficiency and scale. Notable CMOs for formulations akin to CORDRAN SP include:

Jubilant HollisterStier
Mundipharma Manufacturing
Respect Pharma

CMOs are crucial for ensuring supply continuity, especially amid supply chain disruptions.

Regional Suppliers and Distribution

Supply chain networks for CORDRAN SP are regionally segmented, driven by regulatory approvals, manufacturing licenses, and market demand.

1. North America and Europe
Manufacturers such as GSK and Teva dominate, with distribution channels ensuring availability through established pharmaceutical distributors and pharmacies. Stringent regulatory standards by agencies like the FDA and EMA guide sourcing decisions.

2. Asia-Pacific
Manufacturers like Macleods, Sun Pharma, and Lupin play significant roles. India and China are pivotal manufacturing hubs due to cost advantages and regulatory frameworks aligned with global standards (e.g., GMP compliance).

3. Middle East and Africa
Regional markets often rely on licensed local manufacturers. Santé Pharma and local subsidiaries of global companies serve as primary suppliers, adhering to regional regulatory standards.

4. Latin America
Localized production or imports from North American and European suppliers facilitate market access, with key players including Teva and local generic manufacturers.

Regulatory Considerations and Supply Chain Dynamics

Regulatory approvals critically influence supplier viability for CORDRAN SP:

Regulatory Compliance: Suppliers must comply with local regulatory bodies — FDA (U.S.), EMA (Europe), CDSCO (India), and others. This compliance ensures drug quality and facilitates international trade.
Patent and Licensing Agreements: Patent protections and licensing terms influence manufacturing rights, notably in territories with patent expirations or generic licensing.
Quality Assurance and Certifications: Suppliers need validated GMP certifications, transparency in sourcing, and adherence to pharmacopoeial standards (e.g., USP, Ph.Eur).

Supply disruptions often stem from regulatory non-compliance, quality issues, or geopolitical factors impacting manufacturing or logistics.

Supply Chain Challenges and Opportunities

The COVID-19 pandemic highlighted vulnerabilities in the pharmaceutical supply chain, including for CORDRAN SP:

Raw Material Shortages: Dependence on intermediates sourced globally can cause delays.
Manufacturing Bottlenecks: Capacity constraints at licensed plants can impact supply continuity.
Regulatory Hurdles: Changing approval requirements may restrict or delay supply from certain regions.

Conversely, opportunities include:

Regional Manufacturing Expansion: Encouraged to reduce dependence on distant suppliers.
Strategic Stockpiling: Companies are investing in inventory buffers to mitigate disruptions.
Technology Adoption: Digitization and supply chain visibility tools improve forecasting and responsiveness.

Key Players in the CORDRAN SP Supply Chain

Company	Region	Product Scope	Regulatory Approvals	Notes
GSK	Global	Branded & Generic	EMA, FDA, Local Regulatory	Leading producer of anticonvulsants
Teva	Global	Generics	Multiple international agencies	Extensive supply network
Macleods	India, MENA	Generics & FDCs	DCGI, Local Regulations	Cost-effective production hub
Sun Pharma	India, Asia	Generics	DCGI, USFDA	Growing global footprint
Respect Pharma	Middle East	Generics	Local & Regional Approvals	Regional supplier focus

Market Trends Affecting Suppliers

Patent Expiry and Generics Growth: Patent expiries for carbamazepine and sodium valproate create licensing opportunities for generic manufacturers, expanding supplier options.
Regulatory Harmonization: Increased alignment between regional authorities streamlines approval processes, broadening supplier markets.
Quality and Safety Focus: Heightened industry focus on pharmacovigilance intensifies supplier scrutiny and demands higher standards.
Supply Chain Localization: Governments incentivize local manufacturing to enhance drug security, influencing supplier distribution networks.

Conclusion

Effective sourcing of CORDRAN SP involves navigating a complex network of licensed manufacturers, regional suppliers, and regulatory frameworks. Global players like GSK and Teva remain dominant, supported by regional manufacturers in Asia and the Middle East. Ensuring supply chain resilience requires strategic diversification, adherence to quality standards, and leveraging technological advancements. As markets evolve, suppliers that prioritize regulatory compliance, manufacturing scalability, and regional adaptation will be well-positioned to meet global demand.

Key Takeaways

The primary suppliers for CORDRAN SP include established global pharmaceutical companies such as GSK and Teva, supplemented by regional manufacturers in Asia and the Middle East.
Regulatory compliance and GMP certification are critical prerequisites for supplier qualification, affecting availability and market access.
Geopolitical factors and recent supply chain disruptions underscore the importance of diversification and regional manufacturing capabilities.
Patent expirations and generics proliferation present growth opportunities for new and existing suppliers.
Strategic partnerships, technology adoption, and regional manufacturing expansion are vital to securing reliable supply for CORDRAN SP.

FAQs

1. Who are the leading global manufacturers of CORDRAN SP?
Leading global manufacturers include GSK and Teva Pharmaceuticals, both with extensive experience in producing anticonvulsant combination drugs. These companies hold licensing agreements that enable them to produce and distribute CORDRAN SP in multiple regions.

2. Are there regional suppliers of CORDRAN SP in developing markets?
Yes. Regional manufacturers, particularly in India (e.g., Macleods, Sun Pharma) and the Middle East (e.g., Respect Pharma), supply CORDRAN SP through licensed productions that meet local regulatory standards.

3. What factors influence the choice of supplier for CORDRAN SP?
Key factors include regulatory compliance, GMP certification, manufacturing capacity, supply chain reliability, cost-effectiveness, and regional regulatory approvals.

4. How has the COVID-19 pandemic affected supply chains for anticonvulsant drugs like CORDRAN SP?
The pandemic disrupted raw material availability, manufacturing continuity, and logistics. It underscored the importance of diversified supply sources and regional manufacturing to mitigate interdependencies.

5. What future trends will shape the supply landscape for CORDRAN SP?
Emerging trends include increased production of generics post-patent expiry, regional manufacturing initiatives, digitization of supply chains, and regulatory harmonization, all of which will influence supplier dynamics.

Sources

[1] "Pharmaceutical Industry Overview," International Pharmaceutical Regulators Forum, 2022.
[2] "Global Anticonvulsant Market Report," MarketWatch, 2023.
[3] "Regulatory Pathways for Anticonvulsant Drugs," U.S. Food and Drug Administration, 2022.
[4] "The Impact of COVID-19 on Pharmaceutical Supply Chains," WHO, 2021.
[5] "Generic Drug Market Growth and Patent Expiry," IQVIA, 2022.

Suppliers and packagers for CORDRAN SP

CORDRAN SP

Suppliers for the Pharmaceutical Drug: CORDRAN SP