Suppliers and packagers for generic pharmaceutical drug: ERGOCALCIFEROL

ERGOCALCIFEROL

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	Torrent Pharmaceuticals Limited	13668-757-01	100 CAPSULE in 1 BOTTLE (13668-757-01)	2026-02-10
Chartwell Rx	ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	040833	ANDA	Chartwell RX, LLC	62135-439-90	90 CAPSULE in 1 BOTTLE (62135-439-90)	2018-04-30
Onesource Specialty	ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	090455	ANDA	AvPAK	50268-297-15	50 BLISTER PACK in 1 BOX (50268-297-15) / 1 CAPSULE in 1 BLISTER PACK (50268-297-11)	2020-04-07
Onesource Specialty	ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	090455	ANDA	Golden State Medical Supply, Inc.	51407-700-01	100 CAPSULE in 1 BOTTLE, PLASTIC (51407-700-01)	2010-08-03
Onesource Specialty	ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	090455	ANDA	Northwind Health Company, LLC	51655-774-27	12 CAPSULE in 1 BOTTLE, PLASTIC (51655-774-27)	2022-08-29
Onesource Specialty	ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	090455	ANDA	Northwind Health Company, LLC	51655-774-52	30 CAPSULE in 1 BOTTLE, PLASTIC (51655-774-52)	2022-08-29
Onesource Specialty	ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	090455	ANDA	Northwind Health Company, LLC	51655-774-80	8 CAPSULE in 1 BOTTLE, PLASTIC (51655-774-80)	2022-08-29

ERGOCALCIFEROL MANUFACTURING SUPPLIERS

Last updated: February 19, 2026

This report details key suppliers for ergocalciferol, a synthetic form of vitamin D2. Understanding the supply chain is critical for manufacturers of pharmaceutical products utilizing this active pharmaceutical ingredient (API). The analysis focuses on active suppliers, their manufacturing capabilities, and market presence based on publicly available data and patent filings.

Who Are the Primary Manufacturers and Suppliers of Ergocalciferol?

The global supply of ergocalciferol is concentrated among a limited number of manufacturers. These entities possess the specialized chemical synthesis capabilities and regulatory compliance necessary for API production.

• Solvay S.A. is a significant global chemical company with a pharmaceutical ingredients division. They are known to produce a range of APIs, including ergocalciferol. Their manufacturing footprint spans multiple continents, offering potential supply chain redundancy. Solvay's involvement in pharmaceutical intermediates suggests a robust quality control and regulatory framework in place for their ergocalciferol production.
• DSM Nutritional Products is another major player in the vitamin and nutritional ingredients market. While primarily known for food and feed applications, DSM also supplies pharmaceutical-grade ingredients. Their expertise in fermentation and chemical synthesis positions them as a potential ergocalciferol supplier. The company's focus on quality and sustainability aligns with the stringent requirements of the pharmaceutical industry.
• BASF SE is one of the world's largest chemical producers, with a significant presence in life sciences. BASF manufactures a wide array of vitamins and related compounds. Their extensive research and development capabilities and global production network are indicative of their capacity to supply pharmaceutical-grade ergocalciferol.
• Sigma-Aldrich (now part of Merck KGaA), while historically more prominent as a research chemical supplier, also offers pharmaceutical-grade APIs. Their catalog often includes ergocalciferol, serving both research and potentially small-scale commercial needs. Their rigorous quality assurance processes are well-established.

What are the Key Differentiating Factors Among Ergocalciferol Suppliers?

Suppliers of ergocalciferol differentiate themselves through several factors critical to pharmaceutical clients:

• Manufacturing Scale and Capacity: The ability to consistently supply large volumes of API is paramount for commercial drug production. Suppliers with dedicated, large-scale facilities are preferred. Solvay and BASF, with their broad chemical manufacturing infrastructure, are positioned to offer significant capacity.
• Quality Assurance and Regulatory Compliance: Pharmaceutical clients require APIs manufactured under Good Manufacturing Practices (GMP) and compliant with relevant pharmacopeial standards (e.g., USP, EP). Suppliers must demonstrate a strong track record of regulatory inspections and robust quality management systems. This includes robust impurity profiling and control.
• Supply Chain Security and Redundancy: Geopolitical stability, logistical capabilities, and multiple manufacturing sites contribute to supply chain reliability. Companies with diversified production locations can mitigate risks associated with regional disruptions.
• Technical Support and Innovation: Beyond API provision, suppliers offering technical expertise in formulation, process optimization, and ongoing research into product improvement can provide significant added value. While ergocalciferol synthesis is a mature process, suppliers with strong R&D might offer enhanced purity profiles or novel delivery forms.

What is the Patent Landscape Surrounding Ergocalciferol Manufacturing?

While ergocalciferol itself is a well-established compound, patents continue to emerge related to its synthesis, purification, and novel applications. The patent landscape indicates ongoing efforts to refine manufacturing processes and explore new therapeutic uses.

• Process Patents: Innovations in ergocalciferol synthesis often focus on improving yields, reducing byproducts, and enhancing efficiency. Patents might describe novel catalysts, reaction conditions, or purification techniques. For example, research has explored enzymatic synthesis routes as a greener alternative to traditional chemical synthesis [1].
• Formulation Patents: New patent filings may cover specific pharmaceutical formulations incorporating ergocalciferol, aiming to improve its bioavailability, stability, or patient compliance. This can include specialized delivery systems or combinations with other active ingredients.
• Analytical Method Patents: Patents related to advanced analytical techniques for identifying and quantifying ergocalciferol and its impurities can also be relevant. These ensure the quality and safety of the API.
• Therapeutic Use Patents: While ergocalciferol is known for vitamin D deficiency treatment, patents are occasionally filed for new therapeutic indications, such as its potential role in immune modulation or cancer therapy. These patents, while not directly related to manufacturing, can drive demand and influence supplier choices.

A review of patent databases (e.g., USPTO, Espacenet) reveals a consistent, albeit modest, level of patent activity surrounding ergocalciferol over the past two decades. This suggests continuous, incremental innovation rather than disruptive breakthroughs in manufacturing.

Table 1: Key Ergocalciferol Supply Chain Considerations

Factor	Description	Impact on Pharmaceutical Manufacturers
Manufacturing Capacity	Volume of ergocalciferol a supplier can produce.	Ensures ability to meet demand for commercial production; impacts lead times and scalability.
GMP Compliance	Adherence to Good Manufacturing Practices.	Essential for regulatory approval; guarantees API quality, safety, and consistency.
Pharmacopeial Standards	Conformance to USP, EP, JP, or other recognized standards.	Critical for product registration and market access in different geographies.
Impurity Profile	Identification and control of process-related and degradant impurities.	Directly impacts API safety and efficacy; requires rigorous analytical testing and control strategies.
Supply Chain Diversification	Presence of multiple manufacturing sites or raw material sources.	Mitigates risks from single-point failures, natural disasters, or geopolitical disruptions.
Cost of Goods	The overall cost of acquiring ergocalciferol from a supplier.	Impacts the profitability and competitive pricing of the final pharmaceutical product.
Regulatory Support	Assistance with Drug Master Files (DMFs) and other regulatory documentation.	Streamlines the regulatory submission process for the pharmaceutical product.

How Do Ergocalciferol Suppliers Address Regulatory Requirements?

Suppliers of pharmaceutical-grade ergocalciferol must navigate a complex regulatory landscape. Their approach to meeting these requirements is a key indicator of their reliability.

• Drug Master Files (DMFs): Reputable suppliers maintain comprehensive DMFs submitted to regulatory agencies like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). These confidential documents detail the manufacturing process, quality control procedures, and facility information, which drug product manufacturers can reference in their own regulatory submissions.
• Certificates of Analysis (CoAs): Each batch of ergocalciferol supplied is accompanied by a CoA, detailing the results of quality control testing against specified parameters. This includes identity, purity, assay, and limits for known impurities.
• Audits and Inspections: Suppliers must be open to audits by their pharmaceutical clients and regular inspections by regulatory authorities. A history of successful inspections is a strong positive signal.
• Change Control Management: Robust systems for managing changes to the manufacturing process, raw materials, or analytical methods are crucial. Any significant change must be communicated to clients and, if necessary, reflected in updated regulatory filings.
• Traceability: The ability to trace each batch of API back to its raw materials and manufacturing steps is a fundamental regulatory requirement, ensuring accountability and facilitating investigations in case of quality issues.

What are the Challenges in Sourcing Ergocalciferol?

Sourcing ergocalciferol presents several challenges for pharmaceutical companies:

• Limited Number of Qualified Suppliers: The specialized nature of API manufacturing means fewer companies can reliably produce pharmaceutical-grade ergocalciferol. This can lead to reduced competition and potentially higher prices.
• Stringent Quality Demands: Meeting the evolving quality standards and regulatory expectations requires significant investment in quality systems from both suppliers and purchasers. Ensuring consistent purity and a well-defined impurity profile is an ongoing task.
• Geopolitical and Logistical Risks: The global nature of chemical manufacturing means supply chains are susceptible to international trade disputes, shipping disruptions, and regional instability, which can impact availability and cost.
• Cost Pressures: While a mature product, the cost of ergocalciferol can be influenced by raw material prices, energy costs, and regulatory compliance expenses. Pharmaceutical companies face pressure to manage these costs effectively.
• Intellectual Property Considerations: While the core ergocalciferol molecule is off-patent, new synthesis routes or specific applications may be protected by intellectual property, requiring careful due diligence by purchasers to avoid infringement.

Key Takeaways

The supply of ergocalciferol for pharmaceutical applications is primarily handled by a few large chemical and life sciences companies, including Solvay, DSM, and BASF. These suppliers are distinguished by their manufacturing scale, adherence to GMP, and regulatory compliance. The patent landscape reveals ongoing, incremental innovation in synthesis and formulation. Pharmaceutical manufacturers must prioritize suppliers with robust quality systems, secure supply chains, and comprehensive regulatory support, such as readily available DMFs. Key challenges in sourcing include the limited supplier base, stringent quality demands, and potential geopolitical disruptions.

FAQs

1. Can ergocalciferol be sourced from research chemical suppliers for commercial pharmaceutical use? While research chemical suppliers like Sigma-Aldrich may offer ergocalciferol, it is typically not manufactured under GMP conditions required for API use in pharmaceuticals. Commercial pharmaceutical production necessitates sourcing from GMP-certified manufacturers.

2. What are the typical specifications for pharmaceutical-grade ergocalciferol? Pharmaceutical-grade ergocalciferol must meet pharmacopeial monographs, such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP). These monographs define limits for identity, purity, assay, related substances (impurities), and heavy metals.

3. How does patent activity impact the cost and availability of ergocalciferol? While the ergocalciferol molecule itself is off-patent, patents on novel synthesis processes or specific purification methods could potentially influence production costs and exclusivity for those particular methods, indirectly affecting availability and price for manufacturers utilizing those patented techniques.

4. What is the typical shelf-life and storage requirement for ergocalciferol API? Ergocalciferol is sensitive to light, air, and heat. Pharmaceutical-grade ergocalciferol is typically stored in well-closed, light-resistant containers at controlled room temperature or refrigerated conditions to maintain its stability and prevent degradation. Shelf-life is determined by stability studies conducted by the manufacturer.

5. Are there any notable trends in ergocalciferol manufacturing technology? Current trends in pharmaceutical API manufacturing, including for ergocalciferol, focus on green chemistry principles, process intensification, continuous manufacturing, and advanced analytical techniques for better impurity control. Research into enzymatic synthesis is also a growing area.

Citations

[1] Sharma, M., & Gupte, A. (2021). Green synthesis approaches for Vitamin D. RSC Advances, 11(42), 25869-25885. https://doi.org/10.1039/d1ra03515a