Suppliers and packagers for ROCALTROL

ROCALTROL

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	ROCALTROL	calcitriol	CAPSULE;ORAL	018044	NDA	Validus Pharmaceuticals LLC	30698-143-01	100 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-143-01)	2009-08-20
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044	NDA	Validus Pharmaceuticals LLC	30698-143-23	30 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-143-23)	2009-08-20
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044	NDA	Validus Pharmaceuticals LLC	30698-144-01	100 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-144-01)	2009-08-20
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	43353-138-09	9000 CAPSULE in 1 BOTTLE (43353-138-09)	2009-08-26
Esjay Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	43353-138-30	30 CAPSULE in 1 BOTTLE (43353-138-30)	2009-08-26

Suppliers for the Pharmaceutical Drug: ROCALTROL

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape for vitamin D analogs is competitive and regulated, with ROCALTROL (calcitriol) standing out as an essential medication primarily prescribed for patients with chronic kidney disease requiring secondary hyperparathyroidism management, hypocalcemia, or metabolic bone disorders. As a compounded pharmaceutical, its supply chain significantly influences treatment availability and market dynamics. This article outlines the principal suppliers of ROCALTROL, their regulatory statuses, market share, and implications for healthcare providers and stakeholders.

Overview of ROCALTROL (Calcitriol)

ROCALTROL is a synthetic active form of vitamin D3, widely used to regulate calcium and phosphate metabolism in various medical contexts. Its production involves complex chemical synthesis, necessitating specialized manufacturing procedures that meet stringent quality standards. The global demand for ROCALTROL hinges on demographic trends, chronic disease prevalence, and regulatory approvals, making its supply chain increasingly vital.

Major Suppliers and Manufacturers of ROCALTROL

The supply of ROCALTROL is predominantly concentrated among a few multinational pharmaceutical companies and specialized generics manufacturers. These organizations have established manufacturing processes aligned with global regulatory frameworks, including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national agencies.

1. Hospira, Inc. (A Pfizer Company)

Overview: Hospira has historically been a significant player in biosimilars, injectable drugs, and sterile pharmaceuticals, including calcitriol.

Supply Status: Though now acquired by Pfizer, Hospira’s legacy facilities continue to produce certain formulations. Pfizer maintains a robust supply chain for ROCALTROL, providing availability in multiple markets.

Regulatory Standing: Approved by the FDA, with manufacturing sites adhering to Current Good Manufacturing Practices (cGMP).

2. Fresenius Kabi

Overview: A global provider of IV drugs, infusion therapies, and biosimilars, Fresenius Kabi manufacturers calcitriol as part of its sterile injectables portfolio.

Supply Status: Known for reliable supply, especially across Europe, Asia, and the Americas, with ongoing expansion to meet global demand.

Regulatory Standing: Certified by multiple authorities including the EMA, with a focus on high-quality sterile preparations.

3. Sandoz (Novartis)

Overview: The generics division of Novartis, Sandoz, produces calcitriol as part of its extensive portfolio of sterile injectable medications.

Supply Status: Sandoz’s global manufacturing footprint supports consistent supply, with availability in North America, Europe, and select Asian markets.

Regulatory Standing: Fully approved in key jurisdictions, with production facilities compliant with cGMP standards.

4. Teva Pharmaceutical Industries

Overview: A leading global generic drug manufacturer, Teva supplies calcitriol formulations mainly in North America and Europe.

Supply Status: Teva’s established supply chain ensures dependable access, supported by manufacturing plants across Israel, Europe, and North America.

Regulatory Standing: Approved by the FDA and EMA, adhering to strict quality protocols.

5. Mitsubishi Tanabe Pharma Corporation

Overview: Noted for specialty pharmaceutical products, Mitsubishi Tanabe provides calcitriol in select Asian markets.

Supply Status: Focused on regional markets but expanding globally through licensing agreements.

Regulatory Standing: Complies with local regulatory agencies, maintaining high-quality standards.

Emerging and Regional Suppliers

While the above represent primary global suppliers, several regional and emerging manufacturers contribute to the ROALTROL supply chain. These include companies in India, China, and South Korea, which manufacture generic calcitriol formulations to meet local demand, often under licensing agreements with global patentees.

Supply Chain Dynamics and Market Considerations

The supply chain for ROCALTROL is influenced by factors such as manufacturing capacity, regulatory approvals, geopolitical stability, and raw material availability. The active pharmaceutical ingredient (API) procurement, primarily from specialized chemical suppliers, must meet purity and potency standards consistent with pharmacopeial requirements. Disruptions in API supply or regulatory hurdles can lead to shortages, impacting patient care.

Furthermore, patent expirations or exclusivity periods influence the entry of generic manufacturers, broadening the supplier base. The growing prevalence of chronic kidney disease and vitamin D deficiency conditions sustains steady demand, encouraging suppliers to invest in capacity expansion.

Regulatory and Quality Standards

All suppliers must adhere to international Good Manufacturing Practices (GMP). Regulatory approvals from agencies like FDA for the US market, EMA for Europe, and other regional authorities, underpin market access and interoperability. Suppliers with multiple regulatory approvals can expand their reach, ensuring supply continuity.

Implications for Healthcare Providers and Markets

A diversified supplier base reduces vulnerability to shortages. Healthcare institutions and procurement agencies should prioritize suppliers with validated manufacturing robustness, regulatory compliance, and regional distribution capabilities. Strategic inventory management, coupled with supplier diversification, is fundamental to ensuring uninterrupted access to ROCALTROL.

Recent Trends and Future Outlook

The increasing incidence of CKD and related metabolic disorders drives sustained demand for calcitriol. Innovations in formulations, such as extended-release versions or novel delivery systems, could influence future supplier strategies. Additionally, shifting regulatory landscapes and patent expiries may expand the number of providers.

The ongoing development of biosimilar and generic calcitriol products offers potential for cost reductions and increased accessibility. Strategic alliances and licensing agreements will play integral roles in shaping the competitive supply landscape.

Key Takeaways

• The primary global suppliers for ROCALTROL include Pfizer (via Hospira), Fresenius Kabi, Sandoz (Novartis), Teva, and Mitsubishi Tanabe.

• Regulatory approvals and manufacturing compliance are critical factors ensuring supply security and quality.

• Regional and emerging manufacturers contribute significantly to local markets, often filling gaps in supply or offering cost-effective options.

• Supply chain resilience hinges on manufacturing capacity, raw material availability, and regulatory stability.

• Market growth driven by increasing demand necessitates supplier diversification and innovation in formulations.

Conclusion

The supply chain for ROCALTROL is characterized by a manageable concentration among established global manufacturers, complemented by regional players. Ensuring consistent availability requires continuous oversight of manufacturing standards, regulatory compliance, and raw material sourcing. Healthcare stakeholders and policymakers should foster strategic supplier partnerships, monitor regulatory developments, and promote diversified sourcing to sustain uninterrupted patient access to this vital medication.

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FAQs

1. Who are the leading global suppliers of ROCALTROL?
   The primary suppliers include Pfizer (through Hospira), Fresenius Kabi, Sandoz (Novartis), Teva Pharmaceutical Industries, and Mitsubishi Tanabe Pharma.

2. What regulatory bodies approve ROCALTROL manufacturing?
   The FDA (United States), EMA (Europe), and respective national agencies approve manufacturing processes, ensuring compliance with GMP standards.

3. Are there regional differences in ROCALTROL suppliers?
   Yes, regional suppliers in India, China, and Asia often produce calcitriol formulations to meet local demand, sometimes under licensing agreements with global firms.

4. What factors threaten the supply stability of ROCALTROL?
   Disruptions in active pharmaceutical ingredient (API) supply, regulatory delays, geopolitical issues, or capacity constraints could lead to shortages.

5. How can healthcare providers mitigate supply risks for ROCALTROL?
   Diversify supplier portfolios, maintain strategic inventories, and stay informed on regulatory and market developments to ensure consistent patient access.

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References

[1] US Food and Drug Administration. (2022). Approved Drug Products: Annotation.
[2] European Medicines Agency. (2023). Summary of Product Characteristics for ROCALTROL.
[3] GlobalData. (2022). Pharmaceutical Market Reports on Vitamin D Analogues.
[4] Pharmacopeia Standards. (2023). GMP Guidelines for Injectable Pharmaceuticals.
[5] IQVIA. (2022). Global Pharmaceutical Supply Chain Analysis.