Suppliers and packagers for GASTROCROM

GASTROCROM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479	NDA	Viatris Specialty LLC	0037-0678-96	12 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE	2015-05-01
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	51525-0470-9	12 POUCH in 1 CARTON (51525-0470-9) / 8 AMPULE in 1 POUCH (51525-0470-8) / 5 mL in 1 AMPULE	2015-10-21

Suppliers for the Pharmaceutical Drug: GASTROCROM

Last updated: July 28, 2025

GASTROCROM, a well-known antihistamine and anti-inflammatory medication primarily used to treat allergic conditions such as asthma, allergic rhinitis, and urticaria, is manufactured and supplied by various pharmaceutical companies worldwide. Its active ingredient, Cromolyn Sodium, and associated formulations are produced under stringent regulatory standards to ensure quality, safety, and efficacy. This article provides a comprehensive overview of the primary suppliers of GASTROCROM, analysis of the supply landscape, and strategic insights for stakeholders.

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Overview of GASTROCROM and Its Market

GASTROCROM, a brand name for Cromolyn Sodium, was developed in the mid-20th century and remains a critical option in allergy and asthma management. Its inhalation, nasal, and ophthalmic formulations are marketed globally, and it is often available through both branded and generic channels. The global demand for GASTROCROM is driven by the increasing prevalence of allergic respiratory diseases, particularly in developed economies, coupled with the steady expansion in emerging markets.

The market for Cromolyn Sodium is characterized by its presence in both prescription and over-the-counter (OTC) segments, depending on regional regulatory classifications. While a few large pharmaceutical companies dominate the production, numerous generic manufacturers contribute significantly to the supply chain.

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Key Suppliers of GASTROCROM

1. Pharma Companies Producing Branded Cromolyn Sodium Products

• Novartis

  A leading global pharmaceutical company, Novartis historically marketed GASTROCROM inhaler formulations in several markets. While Novartis has scaled back certain respiratory franchises, its contribution to the original development and distribution of Cromolyn Sodium products remains noteworthy. The company's R&D initiatives continue to influence supply in specific regions.

• Sanofi

  Sanofi supplies various allergy and asthma medications, including formulations that contain Cromolyn Sodium, under different regional brands. The company's manufacturing facilities ensure compliance with global quality standards, making Sanofi a significant supplier in the allergy therapeutics segment.

• Meda (now part of Mylan/NOVARTIS)

  Meda Corp, now integrated into Mylan (a subsidiary of Viatris), historically produced Cromolyn-based products, especially in European markets. Their pipeline included inhalers and nasal sprays, catering to both prescription and OTC segments.

2. Major Generic Manufacturers

• Boehringer Ingelheim

  Boehringer Ingelheim manufactures Cromolyn Sodium inhalation solutions for both global markets and regional distribution. Their formulations are often used as benchmarks for quality in generic production.

• Teva Pharmaceutical Industries

  A dominant player in the generics space, Teva supplies various Cromolyn Sodium formulations, particularly in North America and Europe. Their manufacturing facilities adhere to rigorous regulatory standards, ensuring consistent supply.

• Sandoz (a Novartis division)

  Sandoz produces a broad portfolio of generic respiratory drugs, including Cromolyn Sodium inhalers and nasal sprays, supplying multiple markets worldwide.

• ZyOptix and other regional generic manufacturers

  Numerous regional players, especially in India, China, and Latin America, manufacture Cromolyn Sodium products. These manufacturers often focus on affordable formulations for local markets, with export options to neighboring regions.

3. Contract Manufacturing and OEM Partners

Several pharmaceutical companies rely on contract manufacturing organizations (CMOs) to produce Cromolyn Sodium formulations, especially in regions where local brands or private labels dominate. These CMOs often operate under strict confidentiality and quality control regimes, playing a vital role in the supply chain.

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Supply Chain Dynamics and Regional Variations

Regulatory Landscape

The bottleneck for GASTROCROM supply often correlates with regional regulatory approvals. Countries like the U.S. (FDA), Europe (EMA), and Japan (PMDA) impose stringent standards, which manufacturing firms must meet to export or sell their products.

• FDA and EMA approvals are prerequisites for market entry in the United States and Europe, respectively. Manufacturers holding these approvals have competitive advantages and secure exclusive supply rights.

• India’s DCGI and China’s NMPA approvals facilitate regional production and export, especially among local generic manufacturers.

Market Access and Patent Status

GASTROCROM patents have expired decades ago, leading to a proliferation of generics. As no recent patents restrict production, multiple suppliers compete on price, quality, and distribution networks. Market share is mostly distributed among established generics manufacturers in North America, Europe, and Asia.

Supply Chain Risks

The COVID-19 pandemic underscored vulnerabilities in the pharmaceutical supply chain, including shortages of active pharmaceutical ingredients (APIs). Cromolyn Sodium’s API production is concentrated in limited geographies, which could impact supply continuity. Reliance on regional API producers and global logistics disruptions could temporarily affect availability.

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Emerging Trends and Future Outlook

• Expansion in Emerging Markets: Manufacturers are targeting India, Southeast Asia, and Latin America to meet rising demand for allergy medications, often through local generic suppliers.

• Innovation in Formulations: While traditional inhalers and sprays dominate, some companies invest in novel delivery mechanisms and combination products to enhance patient compliance.

• Regulatory Harmonization: Efforts to streamline approvals across regions—through waivers or mutual recognition—may facilitate faster entry and increased competition among suppliers.

• API Production Consolidation: A trend toward vertical integration, with companies investing directly in API manufacturing, aims to secure supply chains and reduce costs.

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Conclusion

GASTROCROM, centered on Cromolyn Sodium, is supplied by a blend of global pharmaceutical giants, regional generic manufacturers, and specialized CMOs. The landscape remains competitive, driven by patent expirations, regional regulatory environments, and the global burden of allergic diseases. Ensuring supply stability involves vigilant monitoring of API production, regulatory compliance, and geopolitical factors affecting logistics.

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Key Takeaways

• The primary suppliers for GASTROCROM include multinational firms such as Boehringer Ingelheim, Teva, Sandoz, Sanofi, and Novartis, along with regional generic manufacturers.

• The widespread availability of generics has significantly lowered prices and increased access in emerging markets but also introduces supply chain complexity.

• API manufacturing concentration and regional regulatory approvals are critical factors influencing supply security and market dynamics.

• Future growth will likely stem from expanding into emerging markets, innovating delivery systems, and streamlining regulatory pathways.

• Stakeholders should monitor raw material sources and geopolitical risks to ensure uninterrupted supply and mitigate market disruptions.

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FAQs

1. Who are the leading global suppliers of Cromolyn Sodium for GASTROCROM?
Leading global suppliers include Boehringer Ingelheim, Teva Pharmaceutical Industries, Sandoz, Sanofi, and Novartis, with regional players in Asia and Latin America also contributing significantly.

2. Are there generic alternatives to GASTROCROM?
Yes. Numerous generic manufacturers produce Cromolyn Sodium formulations, making the drug widely accessible and cost-effective across various regions.

3. What are the main supply chain risks for GASTROCROM?
Key risks include API manufacturing concentration, regulatory delays, logistical disruptions from geopolitical issues, and the impact of global health crises like COVID-19.

4. How does regional regulation impact the supply of GASTROCROM?
Strict regional regulatory standards determine market entry, influence manufacturing practices, and can either facilitate or hinder supply continuity based on approval status.

5. What is the future outlook for GASTROCROM supply?
The market is expected to grow with increased demand in emerging markets, alongside innovations in drug delivery. Supply stability will depend on diversification of API sources and regulatory harmonization efforts.

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Sources:
[1] Market research reports on respiratory drugs and allergy medications.
[2] Public filings and disclosures from pharmaceutical companies (e.g., Novartis, Boehringer Ingelheim).
[3] Regulatory agency databases (FDA, EMA, NMPA).
[4] Industry analyses on global pharmaceutical supply chains.