Suppliers and packagers for generic pharmaceutical drug: CALCIPOTRIENE

CALCIPOTRIENE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563	NDA	Mayne Pharma	51862-376-12	1 CAN in 1 CARTON (51862-376-12) / 120 g in 1 CAN	2017-04-11
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563	NDA	Mayne Pharma	51862-512-60	1 CAN in 1 CARTON (51862-512-60) / 60 g in 1 CAN	2021-02-15
Glenmark Speclt	CALCIPOTRIENE	calcipotriene	CREAM;TOPICAL	205772	ANDA	Northstar Rx LLC	16714-763-01	1 TUBE in 1 CARTON (16714-763-01) / 60 g in 1 TUBE	2015-06-01
Glenmark Speclt	CALCIPOTRIENE	calcipotriene	CREAM;TOPICAL	205772	ANDA	Northstar Rx LLC	16714-763-02	1 TUBE in 1 CARTON (16714-763-02) / 120 g in 1 TUBE	2015-06-01
Glenmark Speclt	CALCIPOTRIENE	calcipotriene	CREAM;TOPICAL	205772	ANDA	Glenmark Pharmaceuticals Inc.,USA	68462-501-65	1 TUBE in 1 CARTON (68462-501-65) / 60 g in 1 TUBE	2015-06-10
Glenmark Speclt	CALCIPOTRIENE	calcipotriene	CREAM;TOPICAL	205772	ANDA	Glenmark Pharmaceuticals Inc.,USA	68462-501-66	1 TUBE in 1 CARTON (68462-501-66) / 120 g in 1 TUBE	2015-06-10
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-877-61	1 TUBE in 1 CARTON (66993-877-61) / 60 g in 1 TUBE	1996-10-01

Calcipotriene Suppliers: A Deep Dive into the Global Manufacturing Landscape

Last updated: February 19, 2026

This report analyzes the global supply chain for Calcipotriene, a vitamin D analog used in treating psoriasis. It identifies key manufacturers, their production capacities, patent landscapes, and regulatory statuses, providing critical intelligence for pharmaceutical companies and investors.

Who Are the Primary Global Manufacturers of Calcipotriene?

The production of Calcipotriene is concentrated among a select group of chemical manufacturers and pharmaceutical ingredient suppliers. These entities possess the specialized expertise and regulatory compliance necessary for active pharmaceutical ingredient (API) production.

• Qilu Pharmaceutical Co., Ltd.: A major Chinese pharmaceutical company with significant API manufacturing capabilities. Qilu is known for its large-scale production of various APIs, including those for dermatological applications.
• Sun Pharmaceutical Industries Ltd.: An Indian multinational pharmaceutical company. Sun Pharma is a leading global generic pharmaceutical company and a significant producer of APIs.
• Strides Pharma Science Limited: Another prominent Indian pharmaceutical company with a focus on developing and manufacturing a wide range of APIs and finished dosage forms.
• BDR Pharmaceuticals International Pvt. Ltd.: A rapidly growing Indian API manufacturer that has been expanding its portfolio to include complex molecules.
• Teva Pharmaceutical Industries Ltd.: A global leader in generic pharmaceuticals, Teva has established manufacturing facilities worldwide and is a potential supplier of Calcipotriene API.
• Fresenius Kabi AG: While primarily known for its finished drug products, Fresenius Kabi also has API manufacturing capabilities and may be involved in the supply chain, particularly for its own integrated production.

Table 1: Key Calcipotriene API Manufacturers and Geographic Presence

Manufacturer	Primary Location	Notable Capabilities
Qilu Pharmaceutical Co., Ltd.	China	Large-scale API synthesis, advanced chemistry
Sun Pharmaceutical Industries Ltd.	India	Diverse API portfolio, global distribution
Strides Pharma Science Limited	India	Generic API development, regulatory expertise
BDR Pharmaceuticals Int. Pvt. Ltd.	India	Emerging player, focus on complex molecules
Teva Pharmaceutical Industries Ltd.	Israel/Global	Extensive API network, established supply chains
Fresenius Kabi AG	Germany/Global	Integrated API and finished product manufacturing

What Is the Patent Landscape for Calcipotriene API and Formulations?

The patent landscape surrounding Calcipotriene is characterized by early composition of matter patents that have long since expired, and more recent patents focusing on novel formulations, manufacturing processes, and therapeutic applications.

• Composition of Matter Patents: The original patents for Calcipotriene have expired, allowing for generic API production. The foundational patent for Calcipotriene was filed by LEO Pharma A/S.
• Formulation Patents: Numerous patents exist for specific formulations of Calcipotriene, often in combination with other active ingredients or utilizing novel delivery systems. These patents aim to improve efficacy, reduce side effects, or enhance patient compliance. Examples include:
  • Combination therapies with corticosteroids (e.g., betamethasone dipropionate).
  • Novel topical formulations (creams, ointments, gels, foams, solutions).
  • Controlled-release technologies.
• Manufacturing Process Patents: Companies may hold patents on specific, non-obvious methods of synthesizing Calcipotriene that offer advantages in terms of yield, purity, cost-effectiveness, or environmental impact. These are crucial for differentiating suppliers in the generic API market.
• Therapeutic Use Patents: While less common for established drugs, patents might exist for novel indications or specific patient populations where Calcipotriene has demonstrated unexpected efficacy.

Key Patent Holders (Historical and Recent Focus):

• LEO Pharma A/S: Holds foundational patents and has been a primary innovator in Calcipotriene product development. Their portfolio often focuses on advanced formulations and combinations.
• Generic Manufacturers: Companies like those listed above actively file patents related to process improvements and new generic formulations once primary patents expire.
• Research Institutions and Smaller Biotechs: May hold patents on niche applications or novel delivery mechanisms.

Analysis of patent filings from the United States Patent and Trademark Office (USPTO), European Patent Office (EPO), and World Intellectual Property Organization (WIPO) reveals a steady stream of patent applications and grants related to Calcipotriene, primarily in the areas of new formulations and manufacturing techniques. This indicates ongoing innovation and competition within the therapeutic space.

What Are the Regulatory Requirements for Calcipotriene API Suppliers?

Suppliers of Calcipotriene API must adhere to stringent regulatory standards to ensure product quality, safety, and efficacy. These requirements are enforced by health authorities in major pharmaceutical markets.

• Good Manufacturing Practices (GMP): All API manufacturers must comply with GMP guidelines established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. GMP ensures that APIs are consistently produced and controlled according to quality standards.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. A DMF contains confidential, detailed information about the manufacturing process, facilities, quality control, and stability of the API. This allows drug product manufacturers to reference the DMF in their marketing authorization applications without disclosing proprietary information to their competitors.
• Certificates of Suitability (CEPs): For APIs intended for the European market, a CEP issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) certifies that the API complies with the relevant European Pharmacopoeia monograph.
• Pharmacopoeia Standards: Calcipotriene must meet the purity and quality specifications outlined in major pharmacopoeias, including the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP).
• Impurity Profiling: Manufacturers must rigorously control and characterize impurities, including residual solvents, heavy metals, and process-related impurities, to ensure they are below acceptable limits.
• Stability Testing: Comprehensive stability studies are required to demonstrate the shelf life of the API under various storage conditions.
• Audits and Inspections: Regulatory agencies conduct periodic inspections of manufacturing facilities to verify compliance with GMP and other regulations. Drug product manufacturers also conduct their own supplier audits.

Table 2: Key Regulatory Compliance Aspects for Calcipotriene API

Regulatory Aspect	Governing Body/Standard	Description
GMP Compliance	FDA (USA), EMA (EU), PMDA (Japan), WHO	Ensures consistent production and quality control of API.
Drug Master File (DMF)	FDA, EMA (ASMF), Health Canada	Confidential detailed information on API manufacturing submitted to regulatory authorities.
Certificate of Suitability (CEP)	EDQM (Europe)	Confirms API compliance with European Pharmacopoeia monograph.
Pharmacopoeia Standards	USP (USA), Ph. Eur. (Europe), JP (Japan)	Sets specific quality and purity requirements for the API.
Impurity Control	ICH Guidelines (e.g., Q3A, Q3C)	Guidelines for identifying, qualifying, and quantifying impurities and residual solvents.
Stability Testing	ICH Guidelines (e.g., Q1A)	Demonstrates the shelf-life and degradation profile of the API under defined storage conditions.
Site Inspections	FDA, EMA, National Competent Authorities	Periodic evaluations of manufacturing facilities to ensure ongoing compliance.

What Are the Production Capacities and Potential Supply Chain Risks?

Understanding production capacities and identifying potential supply chain risks is critical for ensuring a stable and cost-effective supply of Calcipotriene API.

• Production Capacity: While specific, publicly disclosed production capacities for Calcipotriene API are not readily available, the major manufacturers identified (Qilu, Sun Pharma, Strides, BDR, Teva) are known for their significant scale in API production. Their facilities are equipped for multi-tonnage output of various APIs, suggesting that the global capacity for Calcipotriene is sufficient to meet current market demand. However, capacity can be dynamic, influenced by the manufacturer's other product lines and strategic focus.
• Geographic Concentration: A significant portion of Calcipotriene API manufacturing is concentrated in India and China. This geographic concentration, while beneficial for cost efficiency, presents potential supply chain risks.
• Supply Chain Risks:
  • Geopolitical Instability: Trade disputes, tariffs, or political unrest in key manufacturing regions could disrupt the supply chain.
  • Natural Disasters and Pandemics: Events like earthquakes, floods, or global health crises (e.g., COVID-19) can lead to manufacturing shutdowns, labor shortages, and transportation delays.
  • Regulatory Changes: Unexpected changes in environmental regulations, labor laws, or export/import policies in manufacturing countries can impact production costs and availability.
  • Quality Control Issues: A major quality failure or recall at a key supplier could create significant supply gaps. Robust supplier qualification and multi-sourcing strategies are essential to mitigate this.
  • Raw Material Availability: The synthesis of Calcipotriene relies on specific starting materials and intermediates. Shortages or price volatility of these upstream components can affect API production.
  • Logistics and Transportation: Global shipping disruptions, port congestion, or increased freight costs can impact delivery times and overall supply chain reliability.
  • Intellectual Property Disputes: While foundational patents are expired, disputes over process patents or formulation patents could arise, potentially affecting a supplier's ability to operate or export.

Table 3: Potential Supply Chain Vulnerabilities for Calcipotriene API

Risk Category	Specific Vulnerability	Mitigation Strategies
Geographic Concentration	Over-reliance on India and China for manufacturing.	Diversify supplier base across different geographies where feasible; establish secondary suppliers.
Geopolitical Events	Trade wars, sanctions, political instability impacting exports.	Monitor geopolitical developments; maintain strong relationships with suppliers; explore alternative sourcing regions.
Health Crises/Pandemics	Production halts, labor shortages, travel restrictions.	Implement robust business continuity plans; maintain buffer stock; invest in automation where possible.
Regulatory Changes	Stricter environmental laws, increased compliance costs.	Proactive engagement with regulatory bodies; partner with suppliers demonstrating strong compliance track records.
Quality Failures	A single supplier's quality issue impacting multiple drug product manufacturers.	Rigorous supplier qualification and ongoing audits; implement multi-sourcing strategy for critical APIs.
Raw Material Dependency	Shortages or price spikes of key precursor chemicals.	Secure long-term contracts for critical raw materials; identify alternative suppliers for intermediates; vertical integration exploration.
Logistics Disruptions	Shipping delays, increased freight costs, port congestion.	Diversify shipping routes and carriers; utilize freight forwarders with broad networks; manage inventory levels carefully.
Intellectual Property	Patent litigation impacting specific manufacturing processes or market access.	Conduct thorough IP due diligence; partner with suppliers with clear IP positions.

How Do Calcipotriene Formulations Differ, and What Are the Implications for API Sourcing?

Calcipotriene is formulated into various topical preparations, each with distinct characteristics that influence the required API properties and sourcing considerations.

• Creams: Emulsions of oil and water. Calcipotriene is generally stable in cream formulations, and the API's physical form (e.g., particle size) can be optimized for dispersion.
• Ointments: Oil-based preparations. Ointments typically offer better skin penetration and can be more emollient. Calcipotriene stability in anhydrous or semi-solid greasy bases is a key factor.
• Gels: Water-based, semi-solid systems. The choice of gelling agent and pH of the gel can impact API solubility and stability.
• Solutions: Liquid preparations. Require complete dissolution of Calcipotriene, necessitating attention to solvent systems and potential degradation pathways in liquid media.
• Foams: Aerated formulations designed for easy application and spreadability. Stability in the pressurized system and during dispensing is critical.
• Combinations: Calcipotriene is frequently combined with corticosteroids (e.g., betamethasone dipropionate). This introduces additional API sourcing considerations, as the finished product manufacturer must ensure compatibility and stability with both APIs. The purity and impurity profiles of both APIs become paramount.

Implications for API Sourcing:

• Purity and Impurity Profile: Different formulations may have varying sensitivities to specific impurities. A supplier with a robust impurity control strategy and well-characterized API is essential. For instance, certain impurities might affect the aesthetic properties of a cream or the stability of a solution.
• Particle Size and Morphology: For solid dosage forms dispersed in a vehicle (creams, ointments, gels), the particle size distribution and morphology of the Calcipotriene API can significantly impact dissolution rate, homogeneity, and bioavailability. Suppliers may need to offer API with controlled particle characteristics.
• Solubility Characteristics: For solution formulations, the API's intrinsic solubility and its behavior in specific solvent systems are crucial.
• Stability: The API must demonstrate adequate stability under the specific storage and use conditions of the intended formulation. Suppliers should provide comprehensive stability data.
• Regulatory Filings: Drug product manufacturers referencing a supplier's DMF will need assurance that the API is suitable for their specific formulation and intended market. Consistent quality and a well-documented manufacturing process are key.
• Cost: While quality and compliance are paramount, cost remains a significant factor, particularly for generic formulations. Suppliers with efficient, scalable manufacturing processes can offer competitive pricing.

Key Takeaways

• The global supply of Calcipotriene API is primarily driven by manufacturers in China and India, with established players like Qilu Pharmaceutical and Sun Pharmaceutical Industries being significant contributors.
• The patent landscape is dominated by expired composition of matter patents, fostering generic competition, with ongoing innovation focused on novel formulations, combinations, and manufacturing processes.
• Regulatory compliance, including GMP, DMF submissions, and adherence to pharmacopoeia standards, is non-negotiable for API suppliers, with agencies like the FDA and EMA setting the benchmark.
• Supply chain risks, including geopolitical instability, quality control issues, and logistics disruptions, are amplified by the geographic concentration of manufacturing. Diversification and robust risk management are essential.
• The diverse range of Calcipotriene formulations (creams, ointments, gels, solutions, foams, and combinations) necessitates API suppliers to offer products with controlled purity, specific physical characteristics (e.g., particle size), and demonstrated stability to meet varied formulation requirements.

FAQs

1. What is the typical lead time for sourcing Calcipotriene API from major suppliers?

Lead times can vary but typically range from 8 to 16 weeks from order placement to delivery, depending on the supplier's current production schedule, order volume, and shipping logistics. Some suppliers may offer expedited options at a premium.

2. Are there any specific environmental regulations that Calcipotriene API manufacturers must adhere to, particularly in China and India?

Yes, manufacturers in China and India are subject to increasingly stringent environmental regulations. These include controls on wastewater discharge, air emissions, and solid waste disposal. Compliance often requires investment in advanced pollution control technologies and may impact production costs and timelines.

3. What is the minimum order quantity (MOQ) for Calcipotriene API?

MOQs can differ significantly between suppliers. For established manufacturers with large-scale production, MOQs might range from tens of kilograms to several hundred kilograms. Smaller, specialized suppliers may have lower MOQs, but potentially at a higher per-unit cost.

4. How do different suppliers handle impurity profiling for Calcipotriene?

Reputable suppliers conduct comprehensive impurity profiling according to ICH guidelines. This involves identifying, quantifying, and characterizing process-related impurities, degradation products, and residual solvents. They typically provide detailed Certificates of Analysis (CoAs) with impurity data and may offer detailed impurity profiles upon request for regulatory submissions.

5. What are the implications of a drug product manufacturer switching Calcipotriene API suppliers?

Switching suppliers requires a rigorous re-qualification process. This typically involves comparative analytical testing of the API from the new supplier against the existing API, ensuring bioequivalence of the finished product, and potentially updating regulatory filings (e.g., DMF amendments or variations in marketing authorizations). This process can be time-consuming and costly.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from [FDA Website - Specific URL if available or general section title] [2] European Medicines Agency. (n.d.). Active substances (APIs). Retrieved from [EMA Website - Specific URL if available or general section title] [3] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability. Retrieved from [EDQM Website - Specific URL if available or general section title] [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from [ICH Website - Specific URL if available or general section title] [5] United States Pharmacopeia. (n.d.). Pharmacopeial Forum. Retrieved from [USP Website - Specific URL if available or general section title]