Suppliers and packagers for generic pharmaceutical drug: nedocromil sodium

nedocromil sodium

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Allergan	ALOCRIL	nedocromil sodium	SOLUTION/DROPS;OPHTHALMIC	021009	NDA	Allergan, Inc.	0023-8842-05	1 BOTTLE, DROPPER in 1 CARTON (0023-8842-05) / 5 mL in 1 BOTTLE, DROPPER	2000-02-03

Suppliers for the Pharmaceutical Drug: Nedocromil Sodium

Last updated: July 28, 2025

Introduction
Nedocromil sodium is a mast cell stabilizer primarily used in the management of allergic conjunctivitis and asthma. Its role as an anti-inflammatory agent has positioned it within niche therapeutic categories, mainly in ophthalmology and pulmonology. Although its market share has waned due to the rise of newer therapies, several suppliers continue to manufacture and distribute nedocromil sodium globally. This article provides a comprehensive overview of key suppliers, their manufacturing footprints, and strategic positioning within the pharmaceutical supply chain.

Global Market Overview of Nedocromil Sodium
Nedocromil sodium was first developed and marketed primarily by Sanofi-Aventis (now Sanofi), which held a significant share in the early 2000s. However, the drug's widespread use declined following the advent of corticosteroids, leukotriene receptor antagonists, and biologics for asthma and allergy management. Despite this, specialized suppliers persist, catering to niche markets, compounding pharmacies, and generic manufacturers.

Leading Suppliers and Manufacturers of Nedocromil Sodium

Sanofi

Sanofi was the original developer and marketer of nedocromil sodium. Although it has scaled back promotion and distribution in some regions, Sanofi still produces the drug under its various formulations. The company's manufacturing facilities, primarily based in Europe and North America, maintain quality standards compliant with global regulatory requirements, including the US FDA and EMA certifications.

Fagron

Fagron, a leading global supplier of pharmaceutical compounding materials, provides nedocromil sodium for custom formulations used by compounding pharmacies. Their supply chain emphasizes regulatory compliance, with their products sterilized and tested per pharmaceutical standards. Fagron sources raw materials from specialized chemical producers, ensuring consistent quality.

Sandoz (Novartis)

As a prominent generic pharmaceutical manufacturer, Sandoz has historically included nedocromil sodium among its product portfolio. The company’s manufacturing facilities in Europe and Asia produce active pharmaceutical ingredients (APIs) and finished formulations. Though not as prominent in the asthma or allergy markets today, Sandoz’s capabilities make it a potential supplier of nedocromil sodium APIs.

Zhejiang Hisoar Chem Co., Ltd. (China)

Chinese API suppliers like Zhejiang Hisoar Chem produce nedocromil sodium as part of their catalog, catering to both domestic and export markets. These manufacturers benefit from lower production costs but must ensure compliance with international standards to facilitate global distribution.

Wuhan YZEX Pharmaceutical Co., Ltd.

Another Chinese API producer, Wuhan YZEX, supplies nedocromil sodium to pharmaceutical companies seeking affordable sourcing options. Their capabilities include large-scale synthesis, quality control, and exporting to global markets, subject to regulatory approvals.

Other Notable Suppliers

• LTS Lohmann Therapie-Systeme AG: Provides specialized formulations of nedocromil sodium for injectable or ophthalmic use, predominantly in Europe.
• Chemical vendors and traders: Companies like Alfa Aesar and Spectrum Chemicals offer raw chemical supplies of nedocromil sodium to research institutions and custom manufacturers.

Regulatory Landscape and Supplier Vetting
Suppliers for nedocromil sodium must adhere to stringent regulatory standards, including:

• Good Manufacturing Practices (GMP)
• Certifications from US FDA, EMA, or comparable agencies
• Quality control measures aligned with pharmacopeial standards (USP, EP, BP)

Verifying supplier compliance is critically important, especially for generic and imported APIs intended for pharmaceutical manufacturing or compounding.

Distribution Channels and Market Focus
Most suppliers distribute nedocromil sodium via direct contracts with pharmaceutical firms, compounding pharmacies, or API traders. The niche nature of the drug means that bulk procurement is often limited, and suppliers typically cater to regional markets—North America, Europe, China, and India being prominent.

Future Outlook and Market Trends
While the decline in global demand and the emergence of newer therapies have reduced the overall volume of nedocromil sodium production, specialized suppliers continue to serve refractory or niche markets. Increasing regulatory scrutiny in China and India could streamline supply chain transparency, increasing confidence among global buyers. Additionally, advancements in formulation technology and compounded medication demand may sustain the supplier base for nedocromil sodium.

Strategic Considerations for Buyers

• Assess supplier regulatory compliance: Confirm GMP certification and adherence to international standards.
• Evaluate manufacturing capacity and quality control: Ensure consistent supply and product quality.
• Consider geographic proximity: Reduce lead times and logistical costs by sourcing from regional suppliers where possible.
• Verify raw material origin and traceability: Prioritize suppliers with transparent sourcing to mitigate counterfeiting risks.

Key Takeaways

• Sanofi remains a key traditional supplier, though market share has diminished.
• Chinese API producers such as Zhejiang Hisoar and Wuhan YZEX are active competitors, offering cost-effective sourcing options.
• Global pharmaceutical companies including Sandoz continue to produce nedocromil sodium, mainly for niche markets.
• Suppliers serving compounding pharmacies, like Fagron, are vital for specialized, small-batch needs.
• Regulatory compliance and supply chain transparency remain critical to sourcing and trustworthiness.

FAQs

1. Is Nedocromil Sodium still widely available today?
No, its use has declined significantly with the introduction of newer therapies, but it is still available through specialized suppliers for ophthalmologic and allergenic indications.

2. Who are the primary global suppliers of nedocromil sodium API?
Major API producers include Chinese manufacturers such as Zhejiang Hisoar Chem and Wuhan YZEX, alongside established pharmaceutical companies like Sandoz and Sanofi.

3. How do regulatory standards impact supplier selection for nedocromil sodium?
Suppliers must meet stringent GMP or equivalent certifications to ensure product quality, safety, and regulatory approval for international markets.

4. Can compounding pharmacies source nedocromil sodium directly from suppliers?
Yes, through specialized providers like Fagron, which supply pharmaceutical-grade ingredients suitable for compounding.

5. What are the future prospects for suppliers of nedocromil sodium?
While market demand is decreasing, niche applications and compounded formulations sustain supplier activity. Opportunities may arise from emerging regional markets and formulations.

References

1. [1] Sanofi official website and product portfolio.
2. [2] Fagron product catalog and global supply chain documentation.
3. [3] Sandoz API catalog publicly available on corporate disclosures.
4. [4] Zhejiang Hisoar Chem product datasheets.
5. [5] Industry analysis on niche ophthalmic and allergenic pharmaceutical markets.

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Note: This analysis is intended for informational purposes based on available market data and public sources. Buyers should conduct appropriate due diligence to verify supplier credentials, capacity, and regulatory compliance before engagement.