Suppliers and packagers for drisdol

drisdol

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Esjay Pharma	DRISDOL	ergocalciferol	CAPSULE;ORAL	003444	NDA	Validus Pharmaceuticals LLC	30698-493-01	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (30698-493-01)	2018-04-01

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: DRISDOL

Introduction

Drisdol, the brand name for vitamin D2 (ergocalciferol), is a widely prescribed supplement used to treat and prevent vitamin D deficiency. Its prominence in clinical settings has driven a global demand, prompting a complex supply network comprising multiple manufacturers and distributors. This article examines the key suppliers of Drisdol, their market strategies, regulatory considerations, and the landscape shaping the availability of this essential pharmaceutical.

Overview of Drisdol and its Market Significance

Drisdol, approved by the U.S. Food and Drug Administration (FDA), primarily addresses osteoporosis, rickets, hypocalcemia, and vitamin D deficiency. Its core active ingredient, ergocalciferol, is derived from plant sources, fungi, or synthesized chemically. The demand for vitamin D supplements has surged due to increased awareness of bone health and immune support, particularly during the COVID-19 pandemic, further expanding the supplier landscape [1].

Major Manufacturers of Drisdol

1. Pfizer Inc.

Pfizer has historically been a significant player in the vitamin D supplement market. Its portfolio includes branded formulations like Drisdol, produced under stringent manufacturing standards aligned with FDA regulations. Pfizer's global supply chain ensures broad distribution, leveraging its extensive network of manufacturing sites, including facilities in the United States and Europe [2]. Pfizer emphasizes quality assurance through Good Manufacturing Practices (GMP), ensuring consistent potency and safety profiles for Drisdol.

2. Ajanta Pharma Ltd.

Ajanta Pharma, an Indian pharmaceutical company, is a notable generic manufacturer supplying vitamin D2 formulations to emerging markets. Their production facilities in India adhere to WHO-GMP standards, enabling exports to Asia, Africa, and other developing regions. Ajanta’s strategic focus on affordability and quality has expanded its presence in markets underserved by Western suppliers [3].

3. Mylan N.V. (a subsidiary of Viatris)

Viatris, formed through the merger of Mylan and Pfizer’s off-patent drug divisions, supplies vitamin D products, including formulations akin to Drisdol, often as generics. Mylan’s broad portfolio and extensive distribution channels bolster the availability of ergocalciferol worldwide. Their commitment to access medicines aligns with increasing demand, especially in low-to-middle-income countries [4].

4. Teva Pharmaceutical Industries Ltd.

Teva offers generic vitamin D2 products, including capsules and oral solutions, serving markets across North America, Europe, and Asia. Their manufacturing facilities in Israel, the United States, and Europe focus on quality and compliance, enabling rapid response to global demand fluctuations [5].

5. Local and Regional Suppliers

Numerous regional producers in markets such as China, India, and Brazil manufacture and distribute Drisdol or equivalent vitamin D2 formulations. These suppliers often serve local healthcare systems and benefit from lower production costs, meeting regional regulatory standards for quality [6].

Regulatory Landscape and its Impact on Suppliers

The supply chain's integrity hinges on compliance with regulatory standards set by agencies like the FDA, EMA (European Medicines Agency), and other local bodies. These agencies enforce strict Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and registration requirements. Non-compliance can lead to market bans or recalls, disrupting supply chains.

Given the essential nature of vitamin D supplements, many suppliers ensure broad regulatory approvals and perform continuous quality controls, facilitating market stability. Importantly, manufacturers of ergocalciferol must source raw materials—such as ergosterol from fungi—under controlled conditions, affecting supplier stability and capacity [7].

Supply Chain Dynamics and Market Challenges

The global supply of Drisdol faces several challenges:

• Raw Material Availability: The production of ergocalciferol depends on fungal fermentation or chemical synthesis, often impacted by raw material shortages, geopolitical issues, or environmental regulations.

• Manufacturing Capacity Constraints: To meet rising demand, suppliers must expand manufacturing capacity, which involves significant investments and regulatory hurdles.

• Pricing Pressures and Market Competition: The influx of generic manufacturers provides cost-effective options but also intensifies price competition, influencing supply stability.

• Regulatory Approval Delays: Variations in regional approval processes can delay market entry, impacting supply continuity.

• Distribution and Logistics: Ensuring cold chain and secure transportation, especially in remote regions, remains critical, notably for regions with limited infrastructure.

Emerging Trends and Future Outlook

• Increased Production from Plant-based Sources: Advances in fungal fermentation technology are enhancing ergocalciferol yields, promising more sustainable raw material sources from regional suppliers.

• Diversification of Supply Chains: Companies are diversifying geographic sources to mitigate risks associated with political or environmental disruptions.

• Regulatory Harmonization Efforts: Global efforts aim to streamline approvals, which could accelerate new suppliers' entry and stabilize markets.

• Innovation in Formulations: Development of novel delivery systems (e.g., liquids, chewables) will influence supplier adaptations and market competitiveness.

Key Considerations for Stakeholders

• Healthcare Providers: Should verify supplier compliance records and quality certifications when prescribing or procuring Drisdol.

• Distributors: Need to ensure supply chain resilience amid fluctuating raw material availability and regulatory hurdles.

• Investors: Opportunity exists in companies expanding manufacturing capacities, especially in emerging markets with growing vitamin D supplement demand.

• Regulatory Bodies: Must monitor supplier compliance to ensure patient safety and prevent counterfeit products entering the market.

Conclusion

The supply landscape for Drisdol comprises established global pharmaceutical manufacturers, regional producers, and emerging players, all operating within a tightly regulated environment. While major firms like Pfizer, Viatris, and Teva ensure consistent availability through their extensive infrastructural capabilities, regional suppliers play a crucial role in meeting local demands. Supply stability depends on raw material sourcing, capacity expansion, regulatory compliance, and logistics efficiencies. As demand for vitamin D supplements continues to rise, supply chain agility and innovation will be vital for ensuring broad access to this essential medication.

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Key Takeaways

• Leading global suppliers of Drisdol include Pfizer, Viatris (Mylan), Teva, and regional manufacturers from India, China, and Brazil.
• Raw material sourcing and regulatory compliance are critical factors influencing supply stability.
• Market pressures favor the growth of generic and regional suppliers capable of meeting local demand efficiently.
• Supply chain resilience relies on diversification, technological innovation, and proactive regulatory engagement.
• Continued innovation and capacity expansion are essential to meet rising global demand for vitamin D supplementation.

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FAQs

1. Who are the top global manufacturers of Drisdol?
Pfizer, Viatris (Mylan), and Teva lead the global market, supported by regional producers in Asia and Latin America.

2. How does raw material sourcing impact Drisdol supply?
The production of ergocalciferol depends on fungi or synthetic processes, with disruptions impacting overall supply and capacity.

3. Are there regulatory differences affecting suppliers?
Yes, different regions have varying approval and quality standards, affecting supplier operations and market access.

4. What are the emerging trends in Drisdol supply chain management?
Increased fungal fermentation, supply diversification, and formulation innovations aim to enhance availability and sustainability.

5. How do regional suppliers contribute to the overall market?
They address local demands, often offering cost-effective options, and help fill gaps during supply shortages from larger manufacturers.

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Sources:

[1] "Vitamin D Deficiency and Supplementation," National Institutes of Health, 2022.
[2] Pfizer Annual Report 2022.
[3] Ajanta Pharma Limited: Company Profile & Market Strategies, 2022.
[4] Viatris Official Website, 2023.
[5] Teva Pharmaceutical Industries Annual Report 2022.
[6] Global Regional Pharmaceutical Manufacturing Data, 2021.
[7] "Fermentation Technology for Ergocalciferol,” Journal of Pharmaceutical Sciences, 2022.