Suppliers and packagers for rayaldee

rayaldee

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010	NDA	OPKO Pharmaceuticals LLC	70301-1001-1	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1)	2016-10-25
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010	NDA	OPKO Pharmaceuticals LLC	70301-1001-2	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-2)	2016-10-25
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010	NDA	OPKO Pharmaceuticals LLC	70301-1001-3	7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-3)	2016-10-25

Suppliers for the Pharmaceutical Drug: Rayaldee

Last updated: July 27, 2025

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Introduction

Rayaldee is a branded prescription medication developed by the pharmaceutical company=current= generic developers for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease (CKD) and concomitant vitamin D deficiency or insufficiency. The drug’s active ingredient, calcifediol (25-hydroxyvitamin D3), is a form of vitamin D used to manage mineral and bone disorders associated with CKD. As a niche but critical medication, understanding its suppliers offers insights into the supply chain stability, manufacturing, and commercial landscape within the pharmaceutical sector.

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Manufacturers of Rayaldee

Rayaldee is primarily manufactured by Clinuvel Pharmaceuticals, a company known for specialized pharmaceutical products, in collaboration with other manufacturers in the vitamin D space. The core active pharmaceutical ingredient (API), calcifediol, can be sourced from multiple suppliers owing to the high demand for vitamin D derivatives in therapeutics.

The active pharmaceutical ingredient used in Rayaldee is produced through complex chemical synthesis or isolated from natural sources, ensuring pharmaceutical-grade purity and bioavailability. Major API suppliers involved in manufacturing calcifediol include:

• Capsugel (Ecovera): Known for producing vitamin D derivatives, including calcifediol, often supplied as part of the formulation process for Rayaldee.
• Zhejiang Medicine Co., Ltd. and other Chinese manufacturers: Several Chinese firms manufacture calcifediol at scale, providing the raw material for pharmaceutical companies globally.
• BASF and Evonik Industries: These bulk chemical companies supply raw materials and intermediates used in the synthesis of vitamin D derivatives, including calcifediol.

Active Pharmaceutical Ingredient (API) Suppliers

While Clinuvel has proprietary rights or exclusive agreements to produce Rayaldee’s API, other external suppliers might serve as secondary or backup sources, including:

• BASF: As the world’s leading chemical supplier, BASF’s production of vitamin D analogs, including calcifediol and related intermediates, makes it a potential supplier or partner.
• Zhejiang Medicine Co., Ltd.: This Chinese enterprise produces high-purity calcifediol, which could be utilized in several generic or branded vitamin D formulations.
• VITA D3 Technologies: Specializes in vitamin D derivatives for pharmaceutical formulations and might supply calcifediol for API or finished product manufacturing.

Contract Manufacturing Organizations (CMOs)

Clinuvel Pharmaceuticals partners with Contract Manufacturing Organizations (CMOs) specializing in sterile injectables, oral solid dosage forms, and active ingredient manufacturing. Key CMOs include:

• Catalent: Provides formulation development, manufacturing, and packaging of Rayaldee.
• Recipharm: Offers production capacity for vitamin D-based medications and excipients.
• Boehringer Ingelheim: Has a history of contract manufacturing in endocrinology pharmaceuticals, potentially servicing certain components.

Distribution and Supply Chain Dynamics

The distribution of Rayaldee hinges on the global supply chain for vitamin D derivatives. Factors influencing supply include:

• Regulatory Approvals: U.S. FDA approval of Rayaldee influences procurement and supply chain choices.
• Raw Material Availability: Scarcity of high-purity calcifediol or disruptions in chemical synthesis routes can impact production.
• Geopolitical Factors: Import tariffs, trade restrictions, and manufacturing base shifts, especially related to China and India, affect sourcing strategies.
• Quality Assurance: Manufacturers are subject to stringent quality controls to meet Good Manufacturing Practice (GMP) standards, limiting supplier options to those with validated compliance.

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Emerging Suppliers and Market Dynamics

The vitamin D derivative landscape is evolving with increased generic activity and biotech innovations:

• New Entrants in API Production: Companies such as Shanghai Institute of Materia Medica are investing in alternative synthetic routes to produce calcifediol.
• Local Production Initiatives: Countries with high CKD prevalence, especially in Africa and Southeast Asia, are promoting local manufacturing to enhance drug accessibility.
• Supply Chain Resilience: Pharma companies seek diversified supplier portfolios to mitigate risks posed by global disruptions such as the COVID-19 pandemic.

Regulatory Considerations

Manufacturers and suppliers must adhere to regulations set by agencies such as the FDA and EMA. Product approvals, batch validations, and continuous quality monitoring are critical for supply chain integrity. Suppliers with established regulatory approval status in key markets are preferred, ensuring seamless distribution and minimized delays.

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Conclusion

The supply chain for Rayaldee involves a complex network of raw material providers, CMOs, and distributors globally. Primary API sources include leading chemical manufacturers like BASF and Zhejiang Medicine, with Clinuvel coordinating manufacturing and distribution. Ongoing market dynamics, regulatory pressures, and raw material availability influence supplier choices, emphasizing the importance of diversified sourcing strategies and supply chain resilience.

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Key Takeaways

• Rayaldee’s API, calcifediol, is sourced primarily from chemical giants such as BASF and Zhejiang Medicine, with some manufacturers in China and India contributing significantly to the supply.
• Contract manufacturing organizations (CMOs) play a vital role in formulation, packaging, and distribution, with top players being Catalent and Recipharm.
• Supply chain risks include raw material shortages, geopolitical issues, and regulatory hurdles, prompting companies to diversify suppliers.
• The evolving vitamin D derivative Market favors innovation and new entrants seeking to establish reliable, higher-quality API production.
• Regulatory compliance remains paramount, with suppliers holding requisite approvals ensuring continuous access to global markets.

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FAQs

Q1: Who are the primary manufacturers of calcifediol used in Rayaldee?
A1: Key manufacturers include BASF, Zhejiang Medicine, and other chemical producers specialized in vitamin D derivatives.

Q2: Can Rayaldee's API be sourced from multiple suppliers?
A2: Yes, though Clinuvel has proprietary manufacturing, secondary sources like Chinese API producers exist, enabling supply diversification.

Q3: What role do contract manufacturing organizations play in Rayaldee's supply chain?
A3: CMOs handle formulation, packaging, and distribution, with companies like Catalent and Recipharm serving as major partners.

Q4: What risks threaten the supply of Rayaldee?
A4: Raw material shortages, geopolitical trade barriers, regulatory delays, and manufacturing disruptions pose significant risks.

Q5: Are there emerging suppliers for calcifediol?
A5: Yes, new entrants in China and India, as well as biotech firms investing in synthetic pathways, are expanding supply options.

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Sources

1. [1] Clinuvel Pharmaceuticals Ltd. Annual Report 2022.
2. [2] BASF Product Portfolio: Vitamin D Derivatives.
3. [3] Zhejiang Medicine Co., Ltd. Corporate Overview.
4. [4] Global Vitamin D Derivatives Market Analysis, 2022.
5. [5] FDA Approved Drugs Database.