Suppliers and packagers for generic pharmaceutical drug: PARICALCITOL

PARICALCITOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	PARICALCITOL	paricalcitol	CAPSULE;ORAL	204327	ANDA	Amneal Pharmaceuticals LLC	65162-822-03	30 CAPSULE in 1 BOTTLE (65162-822-03)	2016-01-15
Amneal Pharms	PARICALCITOL	paricalcitol	CAPSULE;ORAL	204327	ANDA	Amneal Pharmaceuticals LLC	65162-822-09	90 CAPSULE in 1 BOTTLE (65162-822-09)	2016-01-15
Amneal Pharms	PARICALCITOL	paricalcitol	CAPSULE;ORAL	204327	ANDA	Amneal Pharmaceuticals LLC	65162-823-03	30 CAPSULE in 1 BOTTLE (65162-823-03)	2016-01-15
Amneal Pharms	PARICALCITOL	paricalcitol	CAPSULE;ORAL	204327	ANDA	Amneal Pharmaceuticals LLC	65162-823-09	90 CAPSULE in 1 BOTTLE (65162-823-09)	2016-01-15

Pharmaceutical Suppliers for Paricalcitol

Last updated: February 19, 2026

This report analyzes key suppliers of paricalcitol, a synthetic analog of vitamin D used to treat secondary hyperparathyroidism in patients with chronic kidney disease. The analysis focuses on manufacturing capabilities, regulatory compliance, and market presence, providing data for R&D and investment decisions.

What is Paricalcitol and its Therapeutic Application?

Paricalcitol is a vitamin D analog. It is used therapeutically to manage secondary hyperparathyroidism. This condition commonly affects individuals with chronic kidney disease (CKD) [1]. The drug functions by suppressing parathyroid hormone (PTH) secretion. This action helps normalize calcium and phosphate levels in the blood, mitigating the complications associated with elevated PTH. Paricalcitol is administered intravenously or orally.

Key Manufacturers and Their Role in the Paricalcitol Supply Chain

Several entities play a critical role in the manufacturing and supply of paricalcitol, from active pharmaceutical ingredient (API) production to finished dosage forms.

API Manufacturers

The production of paricalcitol API is a complex process requiring specialized chemical synthesis expertise and adherence to stringent quality controls.

• Abbott Laboratories: As the originator of paricalcitol (marketed as Zemplar), Abbott Laboratories has historically been a primary producer and supplier of the API and finished drug product. While direct API supply agreements can vary, Abbott maintains significant control over its proprietary manufacturing processes [2].
• Generic API Manufacturers: The expiration of primary patents has opened the market to generic manufacturers. Companies specializing in complex API synthesis are involved in producing paricalcitol API for the generic market. Specific names of API manufacturers are often not publicly disclosed due to proprietary business relationships, but they operate under strict Good Manufacturing Practice (GMP) regulations. These manufacturers supply API to formulators of generic paricalcitol products.
• Contract Manufacturing Organizations (CMOs): CMOs with expertise in steroid chemistry and API synthesis can be contracted by pharmaceutical companies to produce paricalcitol API. These organizations operate under client-specific agreements and regulatory oversight.

Finished Dosage Form (FDF) Manufacturers

Companies that formulate and manufacture the final paricalcitol drug product are essential for market access. These include both the innovator company and generic drug producers.

• Abbott Laboratories: Continues to market and distribute Zemplar, its branded paricalcitol product, in various formulations (e.g., capsules, injectable solutions) [2].
• Generic Drug Manufacturers: Numerous pharmaceutical companies produce generic versions of paricalcitol. These manufacturers source paricalcitol API from specialized producers and then formulate, package, and distribute the finished drug product. Examples of companies that have marketed or are involved in the generic paricalcitol space include:
  • Teva Pharmaceutical Industries: A major player in the generic pharmaceutical market, Teva has been involved in the production and supply of generic paricalcitol [3].
  • Sun Pharmaceutical Industries: Another significant global pharmaceutical company, Sun Pharma also has a presence in the generic paricalcitol market.
  • Mylan N.V. (now Viatris): Mylan, prior to its merger with Upjohn to form Viatris, was known for its broad portfolio of generic drugs, including paricalcitol.
  • Dr. Reddy's Laboratories: This company is also active in the development and manufacturing of generic APIs and finished dosage forms, including those for paricalcitol.

Regulatory Landscape and Compliance

The supply of paricalcitol is governed by rigorous regulatory standards to ensure product safety, efficacy, and quality.

Key Regulatory Bodies and Standards

• U.S. Food and Drug Administration (FDA): The FDA oversees the approval and manufacturing of pharmaceutical products in the United States. All paricalcitol API and FDF manufacturers must comply with FDA regulations, including Current Good Manufacturing Practices (cGMP) [4].
• European Medicines Agency (EMA): The EMA is responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union. Manufacturers supplying to the EU market must meet EMA standards.
• Other National Regulatory Authorities: Agencies in countries like Japan (PMDA), Canada (Health Canada), and others have their own specific regulatory requirements that manufacturers must adhere to.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents provide detailed information about the chemistry, manufacturing, and controls of the API, which is then referenced by FDF manufacturers in their drug applications.

GMP Compliance and Inspections

• Manufacturers must maintain facilities and processes that comply with cGMP guidelines. This includes controls over raw materials, manufacturing processes, laboratory testing, packaging, and distribution.
• Regulatory agencies conduct periodic inspections of manufacturing facilities to ensure ongoing compliance. Non-compliance can lead to warning letters, import alerts, or product recalls.
• Example of FDA Action: FDA warning letters detail specific violations of cGMP. For instance, a warning letter to an API manufacturer might cite issues with process validation, impurity control, or laboratory testing procedures. These citations directly impact the ability of the manufacturer to supply compliant API.

Market Dynamics and Intellectual Property

The market for paricalcitol is influenced by patent expirations and the subsequent entry of generic competition.

Patent Status

• Originator Patents: Patents covering paricalcitol itself and its initial therapeutic uses have largely expired or are nearing expiration. Abbott Laboratories held key patents for Zemplar.
• Generic Market Entry: The expiration of these foundational patents has allowed generic manufacturers to enter the market with lower-cost alternatives. This has significantly impacted the pricing and market share of the innovator product.
• Exclusivity Periods: Regulatory pathways, such as those in the Hatch-Waxman Act in the U.S., provide specific periods of market exclusivity for innovator drugs, which are followed by generic entry upon patent expiry and regulatory approval.

Competitive Landscape

• The market is characterized by competition between branded paricalcitol and multiple generic versions.
• Pricing strategies, supply chain reliability, and regulatory approvals are key competitive factors for both API and FDF manufacturers.
• Innovation in paricalcitol formulations or delivery methods could also emerge, creating new intellectual property and market opportunities. However, the focus for many players remains on efficient API synthesis and cost-effective FDF production.

Analytical Considerations for Suppliers

When evaluating paricalcitol suppliers, several analytical points are critical for ensuring a robust and compliant supply chain.

API Quality and Purity

• Impurity Profiling: Comprehensive analysis of process-related impurities and degradation products is essential. This involves using advanced analytical techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), and Nuclear Magnetic Resonance (NMR) spectroscopy. The acceptable limits for impurities are defined by pharmacopeial standards (e.g., USP, EP) and regulatory guidance (e.g., ICH guidelines) [5].
• Chiral Purity: Paricalcitol is a stereoisomer. Ensuring high chiral purity is critical for therapeutic efficacy and safety. Techniques like chiral HPLC are employed for this analysis.
• Residual Solvents: Manufacturers must control and monitor residual solvents used during synthesis to meet safety standards defined by ICH Q3C guidelines.
• Trace Metals: Analysis for trace metal contaminants, often using Inductively Coupled Plasma Mass Spectrometry (ICP-MS), is necessary to ensure product safety.

Manufacturing Process Controls

• Process Validation: Suppliers must demonstrate that their manufacturing processes consistently produce API of the required quality. This involves rigorous validation studies.
• Change Control: Robust systems for managing changes to manufacturing processes, equipment, or raw materials are critical. Any significant change must be evaluated for its impact on API quality and potentially reported to regulatory authorities.
• Batch-to-Batch Consistency: Suppliers must provide data demonstrating consistent quality across multiple production batches. This is often reviewed as part of supplier qualification and ongoing quality agreements.

Supply Chain Security and Reliability

• Global Sourcing Risks: For companies sourcing API globally, understanding geopolitical stability, trade regulations, and logistical challenges in supplier regions is important.
• Audits and Quality Agreements: Regular quality audits of suppliers are crucial. Formal quality agreements should be established to define responsibilities, specifications, and communication protocols.
• Contingency Planning: Identifying secondary suppliers or developing in-house manufacturing capabilities can mitigate risks associated with single-source dependencies.

Key Takeaways

• Abbott Laboratories remains a key player as the originator, while a competitive generic API and FDF manufacturing landscape has emerged following patent expiries.
• Regulatory compliance, particularly adherence to cGMP and robust quality management systems, is paramount for all paricalcitol suppliers.
• Thorough analytical characterization of API, including impurity profiling and chiral purity, is critical for ensuring product safety and efficacy.
• Supply chain diversification and robust quality agreements are essential for mitigating risks in the paricalcitol market.

FAQs

1. What are the primary therapeutic indications for paricalcitol? Paricalcitol is primarily used to treat and prevent secondary hyperparathyroidism in patients with chronic kidney disease, both on dialysis and not on dialysis.

2. Which regulatory bodies are most critical for paricalcitol suppliers to satisfy? The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the most critical regulatory bodies for suppliers targeting these major pharmaceutical markets. Compliance with national authorities in other target markets is also necessary.

3. What analytical techniques are essential for ensuring the quality of paricalcitol API? Essential analytical techniques include High-Performance Liquid Chromatography (HPLC) for purity and impurity profiling, Gas Chromatography-Mass Spectrometry (GC-MS) for volatile impurities, Nuclear Magnetic Resonance (NMR) spectroscopy for structural elucidation, and chiral HPLC for stereoisomeric purity.

4. How does patent expiration impact the paricalcitol supply chain? Patent expiration significantly increases competition by allowing generic manufacturers to produce and market paricalcitol. This typically leads to price reductions and broader market access for the drug.

5. What are the key considerations when auditing a potential paricalcitol API supplier? Key considerations include the supplier's cGMP compliance, history of regulatory inspections, process validation documentation, robust quality control procedures, impurity control strategies, and supply chain security.

Citations

[1] National Kidney Foundation. (n.d.). Secondary Hyperparathyroidism. Retrieved from https://www.kidney.org/atoz/content/secondary-hyperparathyroidism

[2] Abbott Laboratories. (2023). Zemplar® (paricalcitol) Capsules and Injection. Retrieved from https://www.rxlist.com/zemplar-drug.htm (Note: While RxList provides product information, the original developer is Abbott Laboratories.)

[3] Teva Pharmaceutical Industries. (n.d.). Product Portfolio. Retrieved from https://www.tevapharm.com/ (Note: Specific product availability may vary by region and is subject to change.)

[4] U.S. Food and Drug Administration. (2023). Current Good Manufacturing Practice (cGMP) for Drugs. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/current-good-manufacturing-practice-cgmp

[5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Quality Guidelines. Retrieved from https://www.ich.org/products/guidelines/quality