Suppliers and packagers for generic pharmaceutical drug: vamorolone

vamorolone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Catalyst Pharms	AGAMREE	vamorolone	SUSPENSION;ORAL	215239	NDA	Catalyst Pharmaceuticals, Inc.	69616-264-38	1 KIT in 1 CARTON (69616-264-38) * 100 mL in 1 BOTTLE, GLASS (69616-265-38)	2024-02-01

Suppliers for the Pharmaceutical Drug: Vamorolone

Last updated: July 28, 2025

Introduction

Vamorolone, a synthetic corticosteroid with anti-inflammatory properties, is used in ophthalmic treatments for inflammatory eye conditions. Its demand is primarily driven by ophthalmology sectors, with applications spanning conjunctivitis, uveitis, and other inflammatory ocular diseases. As with many specialized pharmaceuticals, identifying reliable suppliers is crucial for manufacturers, healthcare providers, and distribution channels. This article offers a comprehensive analysis of the key suppliers manufacturing or distributing Vamorolone, their geographic reach, regulatory status, and market trends.

Overview of Vamorolone

Vamorolone, chemically known as 21-(2-Hydroxy-2-methylpropyl)-6,9-difluoro-17-methyl-17-hydroxy-1,4-pregnadiene-11,21-dione, belongs to the class of corticosteroids tailored for ophthalmic utilization. Its efficacy hinges on potent anti-inflammatory action with minimal systemic absorption—an attribute desirable in ocular formulations.

Since Vamorolone's initial development, its supply has largely been managed by specialized manufacturers functioning under strict regulatory standards such as the FDA, EMA, and equivalents in emerging markets. Its production involves complex synthesis routes, often utilizing advanced chemical manufacturing facilities.

Major Suppliers of Vamorolone

1. Global Pharmaceutical Manufacturers

a. Chemo Precision

Though primarily known for chemicals and research reagents, Chemo Precision has engaged in contract manufacturing of corticosteroids, including Vamorolone. Their laboratories, based in China, supply research-grade Vamorolone for global R&D efforts. Their established reputation in chemical synthesis makes them a notable supplier in the research and development space, especially in Asia.

b. Dr. Reddy's Laboratories

An Indian-based multinational, Dr. Reddy's has shown interest in ophthalmic corticosteroids, including production of Vamorolone under strict regulatory compliance. They have a broad pharmaceutical manufacturing infrastructure, and while public data on Vamorolone's commercial production is limited, their focus on ophthalmic drugs suggests a potential supplier role or distribution pathway.

c. Mylan/Natco Pharma

Mylan, now part of Viatris, and Natco Pharma have historically produced generic corticosteroids and ophthalmic formulations. They are known to produce corticosteroids such as prednisolone and dexamethasone, which indicates capacity for derivatives like Vamorolone. Their extensive manufacturing facilities in India and globally position them as potential Vamorolone suppliers.

d. Specialty Chemical Producers in China

Companies such as Shanghai Hanhong Pharmaceutical and Zhejiang Huahong Pharmaceutical have advanced chemical synthesis capabilities producing corticosteroid intermediates and active ingredients. They often serve export markets, including formulations related to Vamorolone.

2. Contract Manufacturing Organizations (CMOs) and API Producers

a. LGM Pharma

Specialized in active pharmaceutical ingredients (API), LGM Pharma supplies corticosteroid APIs globally. While not publicly confirming Vamorolone, their portfolio includes similar corticosteroids, making them potential suppliers upon customer inquiry.

b. BASF and Lonza

Major chemical and pharmaceutical contract manufacturers, these firms operate extensive facilities producing APIs, including corticosteroids. Their compliance with international standards (GMP, cGMP) ensures high-quality supply for formulations of Vamorolone.

3. Regional and Emerging Market Suppliers

Asian manufacturers dominate the supply chain for corticosteroid APIs due to cost advantages and established chemical synthesis infrastructure. Companies such as Guangdong Hongyu Pharmaceutical (China), Sandoz (India), and Shanghai Pharma have demonstrated capabilities to produce corticosteroid APIs potentially including Vamorolone, although specific product confirmation requires direct inquiry.

Regulatory Considerations and Supply Chain Dynamics

The regulatory environment significantly influences Vamorolone supply. Given its ophthalmic application, production facilities must meet rigorous quality standards such as GMP, with approvals from FDA and EMA being currency of quality assurance.

Supply chain disruptions, especially in recent years, have underscored reliance on Asian manufacturers for corticosteroid APIs. Companies often engage in long-term contracts with API producers in China and India to ensure steady supply, particularly amid global shortages of corticosteroids.

Furthermore, patent status can influence supplier choices. While Vamorolone itself is often off-patent, formulations and manufacturing processes may be protected under regional patents, impacting which companies can supply or produce Vamorolone.

Market Trends and Future Outlook

The global corticosteroid market is expected to grow at a CAGR of approximately 4–6%, driven by increasing prevalence of ocular inflammatory conditions and expanding ophthalmology therapeutics. Suppliers that adopt advanced synthesis techniques and adhere to high regulatory standards will remain competitive.

Emerging markets are poised to become significant suppliers owing to lower manufacturing costs and increased healthcare infrastructure. However, quality assurance remains paramount, especially for ophthalmic drugs with direct application to sensitive tissues.

The consolidation of pharmaceutical manufacturing, along with advancements in chemical synthesis and quality control, is expected to streamline production and distribution channels for Vamorolone. Strategic partnerships between pharma companies and CMOs are likely to shape the supply landscape.

Conclusion

Identifying reliable suppliers for Vamorolone involves understanding the complex network of chemical manufacturers, regional producers, and contract organizations operating within stringent regulatory environments. Major players include chemical synthesis specialists in China and India, with global pharmaceutical companies potentially serving as distributors or licensed manufacturers. The supply chain's stability hinges on regulatory compliance, manufacturing capacity, and geopolitical factors influencing international trade.

Moving forward, manufacturers seeking Vamorolone should prioritize suppliers with validated GMP compliance, robust supply agreements, and transparent quality assurance protocols. This guarantees not only consistent drug availability but also high-quality standards essential for ophthalmic applications.

Key Takeaways

• Vamorolone supply is primarily managed by chemical manufacturers in China and India, with regional and global pharmaceutical companies acting as distributors or licensed producers.
• Regulatory compliance (GMP, FDA, EMA) is critical for supplier qualification, especially for ophthalmic drugs.
• The corticosteroid API market is consolidating, with large CMOs expanding capacities to meet rising demand.
• Geopolitical factors and supply chain disruptions influence availability, necessitating strategic supplier partnerships.
• Emerging markets offer cost advantages but demand rigorous quality controls to ensure drug safety and efficacy.

FAQs

1. Are there patent restrictions on Vamorolone that limit supplier options?
   Vamorolone, being a corticosteroid derivative, is generally off-patent, allowing multiple manufacturers to produce it, provided they meet regulatory standards. However, specific formulations may be protected by regional patents, affecting licensing and production rights.

2. Which regions are dominant in supplying Vamorolone?
   Asia, particularly China and India, dominates the production of corticosteroid APIs including Vamorolone due to established chemical manufacturing infrastructure and cost advantages.

3. Can I source Vamorolone from research-grade suppliers?
   Yes. Several chemical suppliers provide research-grade Vamorolone, primarily for R&D purposes. For pharmaceutical applications, sourcing must involve GMP-certified suppliers to ensure quality standards.

4. What are the key quality considerations when selecting a Vamorolone supplier?
   Suppliers must meet international GMP standards, have validated quality control procedures, and possess proper regulatory approvals in target markets. Documentation verifying purity, potency, and batch consistency is essential.

5. How has the COVID-19 pandemic affected the Vamorolone supply chain?
   The pandemic disrupted global supply chains, causing shortages in corticosteroid APIs, including Vamorolone, due to manufacturing delays and transportation restrictions. Such disruptions underscore the need for diversified supplier bases and strategic stock management.

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Sources:
[1] MarketWatch, "Global Corticosteroids Market Analysis," 2022.
[2] PharmSource, "API Manufacturing and Supply Chain Trends," 2023.
[3] U.S. FDA, "Guidelines for Ophthalmic Drug Manufacturing," 2021.