Bulk Pharmaceutical API Sources for GOPRELTO

Bulk Pharmaceutical API Sources for GOPRELTO

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS024457309
Sigma-Aldrich		1143008_USP
Sigma-Aldrich		19330_SIAL
Sigma-Aldrich		51621_SIAL
Sigma-Aldrich		C1528_SIAL
Sigma-Aldrich		C5776_SIGMA
LGC Standards		LGCFOR1345.00

GOPRELTO Bulk Active Pharmaceutical Ingredient (API) Sources

Last updated: February 19, 2026

This report identifies current and potential bulk active pharmaceutical ingredient (API) suppliers for GOPRELTO (paricalcitol). It analyzes patent landscapes, manufacturing capabilities, and regulatory considerations relevant to API sourcing.

What is GOPRELTO and its Therapeutic Use?

GOPRELTO is a brand name for paricalcitol, a vitamin D analog. It is indicated for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on dialysis. SHPT is a complication of CKD characterized by an overproduction of parathyroid hormone (PTH), which can lead to bone disease and cardiovascular problems. Paricalcitol works by suppressing PTH synthesis and secretion.

The active pharmaceutical ingredient is paricalcitol. Its chemical name is (1α,3β,5Z,7E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol. The molecular formula is C27H44O2, and its molecular weight is 400.64 g/mol.

Patent Landscape for Paricalcitol

The patent landscape for paricalcitol is a critical factor in identifying API sources. Patents protect the active ingredient itself, its synthesis methods, and its formulations. Understanding patent exclusivity periods dictates market entry for generic manufacturers and influences API sourcing strategies.

The original patent for paricalcitol was held by Abbott Laboratories (now AbbVie). Key patents have expired or are nearing expiration, opening opportunities for generic competition.

• US Patent 5,200,570: This patent, covering synthetic analogs of vitamin D, including paricalcitol, was granted in 1993. Its term has expired.
• US Patent 5,516,889: This patent, related to the use of paricalcitol in treating secondary hyperparathyroidism, was granted in 1996. Its term has expired.
• US Patent 6,521,639: This patent, covering methods of manufacturing paricalcitol, has also expired.

While composition of matter patents have expired, patents related to specific polymorphic forms, novel synthesis routes, or extended-release formulations could still be in force. Companies looking to source paricalcitol API for generic products must conduct thorough freedom-to-operate (FTO) analyses to avoid infringement.

Current and Potential API Manufacturers

The production of paricalcitol API requires specialized chemical synthesis capabilities. Manufacturers must adhere to strict Good Manufacturing Practices (GMP) and possess the analytical expertise to ensure API purity and quality.

Identified API Manufacturers

Several manufacturers globally have demonstrated capabilities in producing paricalcitol or are likely to have the capacity to do so. These include:

• Cosette Pharmaceuticals: While primarily known as a finished dosage form manufacturer, Cosette has backward integration capabilities and may produce or source API for its generic products, including paricalcitol.
• Teva Pharmaceuticals: As one of the largest generic drug manufacturers, Teva has extensive API manufacturing and sourcing networks. They are a strong candidate to produce or procure paricalcitol API for their own generic paricalcitol products.
• Viatris Inc. (formerly Mylan and Upjohn): Similar to Teva, Viatris possesses broad API manufacturing and sourcing operations and is likely involved in the paricalcitol API supply chain.
• Sun Pharmaceutical Industries: Sun Pharma, a major global pharmaceutical company, has a significant API manufacturing base and capabilities in complex steroid synthesis, which would be relevant for paricalcitol.
• Divi's Laboratories: A leading Indian API manufacturer, Divi's has extensive experience in producing complex molecules. They are a potential supplier for paricalcitol.
• Hospira (a Pfizer company): While Hospira's focus has shifted, Pfizer's broader API manufacturing and sourcing network could include paricalcitol.

Emerging API Suppliers

The expiration of key patents creates opportunities for new API manufacturers to enter the market. These may include:

• Specialized Contract Manufacturing Organizations (CMOs): CMOs with expertise in steroid chemistry and GMP compliance are prime candidates. Companies like:
  • Lonza Group: A global leader in contract development and manufacturing, Lonza has broad API capabilities.
  • Catalent Pharma Solutions: Catalent offers integrated API development and manufacturing services.
• Chinese API Manufacturers: China is a significant source of pharmaceutical APIs. Manufacturers with expertise in Vitamin D analogs and steroid synthesis could emerge as suppliers. Due diligence regarding quality and regulatory compliance is paramount. Examples include companies that have previously supplied APIs for related steroidal compounds.
• Indian API Manufacturers: India is another major hub for API production. Companies like:
  • Laurus Labs: Known for complex API manufacturing, including steroidal APIs.
  • Aarti Industries: A diversified chemical company with a strong API division.

Manufacturing Considerations for Paricalcitol API

The synthesis of paricalcitol is a multi-step process involving complex organic chemistry. Key considerations for API manufacturers include:

• Stereochemistry Control: Paricalcitol has multiple chiral centers, requiring precise stereoselective synthesis to obtain the correct isomer.
• Starting Materials: Sourcing reliable and high-purity starting materials is crucial. Common precursors for Vitamin D analogs are derived from sterols, such as cholesterol or ergosterol.
• Reaction Conditions: Specific reaction conditions, including catalysts, solvents, temperature, and pressure, must be optimized for yield and purity.
• Purification: Multiple purification steps, such as chromatography and crystallization, are necessary to remove impurities and achieve the required API specifications.
• Analytical Methods: Robust analytical methods, including High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS), and Nuclear Magnetic Resonance (NMR), are essential for characterizing the API and ensuring its quality.
• Impurity Profiling: Identification and control of process-related impurities and degradation products are critical for regulatory compliance. This includes genotoxic impurities.
• Scale-Up: Successfully scaling up the synthesis process from laboratory to commercial volumes while maintaining quality and cost-effectiveness is a significant challenge.

Regulatory Landscape and GMP Compliance

API sourcing for pharmaceutical products is heavily regulated by health authorities worldwide, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others.

• Good Manufacturing Practices (GMP): API manufacturers must operate in compliance with current GMP standards (cGMP). This includes stringent controls over manufacturing processes, quality control, documentation, personnel training, and facility maintenance. FDA regulations, such as 21 CFR Parts 210 and 211, and ICH Q7 guidelines for APIs, are paramount.
• Drug Master Files (DMFs): API manufacturers typically submit a DMF to regulatory authorities. A DMF contains detailed information about the manufacturing process, facilities, quality control, and stability of the API. Pharmaceutical companies referencing the DMF in their drug applications can then rely on this information for regulatory review.
• Inspections and Audits: Regulatory authorities conduct inspections of API manufacturing facilities to ensure compliance. Pharmaceutical companies also conduct supplier audits to verify the quality and reliability of their API sources.
• Quality Agreements: Formal quality agreements between the API supplier and the drug product manufacturer are essential. These agreements outline responsibilities regarding quality control, change management, recalls, and other critical aspects.
• Impurity Standards: Manufacturers must adhere to established impurity limits for paricalcitol, as defined by pharmacopoeias (e.g., USP, EP) and regulatory guidelines (e.g., ICH Q3A/B).

Supply Chain Risk Assessment

A robust supply chain for paricalcitol API requires a thorough risk assessment to mitigate potential disruptions. Key risk factors include:

• Geopolitical Instability: Reliance on API manufacturers in regions prone to political or economic instability can create supply chain vulnerabilities.
• Single-Source Dependency: Dependence on a single API manufacturer, or limited number of manufacturers, increases the risk of supply disruption due to capacity issues, quality problems, or unexpected plant closures.
• Raw Material Availability: Shortages or price volatility of critical starting materials and reagents can impact API production.
• Regulatory Changes: Evolving regulatory requirements or increased scrutiny on specific manufacturing practices can affect supplier compliance and availability.
• Quality Incidents: Any quality failure or recall by an API supplier can have significant downstream impacts on drug product manufacturing and market supply.
• Logistics and Transportation: Delays or disruptions in shipping and transportation can affect the timely delivery of API.

To mitigate these risks, companies should aim for a multi-sourcing strategy where feasible, qualify multiple API suppliers, maintain adequate inventory levels, and conduct regular risk assessments of their supply chain partners.

Key Takeaways

• Patent Expirations: Key patents for paricalcitol have expired, creating a more competitive landscape for generic API supply.
• Manufacturing Expertise: Paricalcitol synthesis requires specialized expertise in stereoselective organic chemistry and GMP-compliant manufacturing.
• Established Players: Large generic manufacturers and established API producers are likely to be primary sources.
• Emerging Opportunities: Specialized CMOs and manufacturers in China and India represent potential new sources, subject to rigorous qualification.
• Regulatory Compliance: Strict adherence to GMP and successful DMF filings are critical for API suppliers.
• Supply Chain Diversification: A multi-sourcing strategy and ongoing risk assessment are essential to ensure a secure API supply chain.

Frequently Asked Questions

What are the primary regulatory requirements for paricalcitol API suppliers?

API suppliers must comply with current Good Manufacturing Practices (cGMP) as defined by regulatory bodies like the FDA and EMA. They must also typically file Drug Master Files (DMFs) detailing their manufacturing processes, quality control measures, and stability data.

How does the patent status of paricalcitol affect API sourcing?

The expiration of primary composition of matter and method of use patents for paricalcitol allows for generic competition. This opens the market to multiple API manufacturers, potentially increasing supply and reducing costs. However, manufacturers must still ensure freedom-to-operate concerning any remaining patents on specific synthesis routes or polymorphic forms.

What are the critical quality attributes for paricalcitol API?

Critical quality attributes include high purity, correct stereochemistry, absence of specified impurities (including genotoxic impurities), appropriate particle size distribution (if relevant for formulation), and consistent stability. Analytical methods must be validated to demonstrate these attributes.

What are the typical challenges in the synthesis of paricalcitol API?

Challenges include achieving precise stereochemical control due to multiple chiral centers, managing complex multi-step reactions, sourcing high-purity starting materials, and implementing effective purification techniques to remove process-related impurities.

How can pharmaceutical companies ensure the reliability of their paricalcitol API supply chain?

Companies can ensure reliability by qualifying multiple API suppliers, conducting thorough site audits and quality assessments, establishing robust quality agreements, maintaining appropriate inventory levels, and continuously monitoring geopolitical and market factors that could impact supply.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations Title 21 - Food and Drugs. Retrieved from https://www.ecfr.gov/current/title-21 [2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. Retrieved from https://www.ema.europa.eu/en/documents/scientific-guideline/ich-harmonised-tripartite-guideline-good-manufacturing-practice-guide-active-pharmaceutical-ingredients-q7_en.pdf [3] U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://www.uspto.gov/patents/search [4] European Medicines Agency. (n.d.). European Public Assessment Reports (EPARs). Retrieved from https://www.ema.europa.eu/en/medicines/human/medicines-evaluations