Suppliers and packagers for generic pharmaceutical drug: CALCIUM GLUCONATE

CALCIUM GLUCONATE

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	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	216611	ANDA	Amneal Pharmaceuticals Private Limited	80830-1672-2	10 VIAL in 1 CARTON (80830-1672-2) / 10 mL in 1 VIAL (80830-1672-1)	2024-05-13
Amneal	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	216611	ANDA	Amneal Pharmaceuticals Private Limited	80830-1672-5	25 VIAL in 1 CARTON (80830-1672-5) / 10 mL in 1 VIAL (80830-1672-1)	2024-05-13
Amneal	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	216611	ANDA	Amneal Pharmaceuticals Private Limited	80830-1673-2	10 VIAL in 1 CARTON (80830-1673-2) / 50 mL in 1 VIAL (80830-1673-1)	2024-05-13

Calcium Gluconate: Key Global Suppliers and Manufacturing Landscape

Last updated: February 19, 2026

This analysis identifies and profiles key global suppliers of pharmaceutical-grade calcium gluconate, focusing on production capacity, market presence, and regulatory compliance. The data is crucial for pharmaceutical companies seeking to secure reliable supply chains for this essential drug ingredient.

Who are the Primary Manufacturers of Pharmaceutical-Grade Calcium Gluconate?

The global market for pharmaceutical-grade calcium gluconate is characterized by a mix of established chemical manufacturers and specialized pharmaceutical ingredient suppliers. Production is concentrated in regions with robust chemical manufacturing infrastructure and stringent quality control standards.

Table 1: Leading Global Calcium Gluconate Suppliers

Company Name	Primary Location	Key Product Offerings	Notable Certifications	Annual Production Capacity (Est.)
Jost Chemical Co.	USA	Calcium Gluconate USP/EP, Calcium Citrate	USP, EP, FCC, Kosher, Halal	5,000+ metric tons
Ward Blenkinsop	UK	Calcium Gluconate USP/EP	GMP, ISO 9001	2,000+ metric tons
Haorui Pharma-Tech Co., Ltd.	China	Calcium Gluconate USP/EP	GMP, ISO 9001, HACCP	10,000+ metric tons
CCM (Chia Cheng Metal)	Taiwan	Calcium Gluconate USP/EP	GMP, ISO 14001	3,000+ metric tons
Anhui Donghua Chemical Co., Ltd.	China	Calcium Gluconate USP/EP	GMP, ISO 9001	8,000+ metric tons
Shandong Xinhua Pharmaceutical Co., Ltd.	China	Calcium Gluconate USP/EP	GMP, FDA registered	7,000+ metric tons
Jiangsu Jiujiu Pharmaceutical Co., Ltd.	China	Calcium Gluconate USP/EP	GMP, ISO 9001	6,000+ metric tons
Uquifa	Spain	Calcium Gluconate USP/EP	GMP, ICH Q7	4,000+ metric tons
Neuland Laboratories Ltd.	India	Calcium Gluconate USP/EP	GMP, US FDA, EDQM	3,000+ metric tons
Synthon	Netherlands	N/A (Focus on APIs, less direct calcium gluconate mention)	GMP, ISO	N/A

Note: Production capacities are estimates based on public data and industry reports and may fluctuate.

What are the Manufacturing Processes and Quality Standards for Calcium Gluconate?

The synthesis of pharmaceutical-grade calcium gluconate typically involves the reaction of gluconic acid or its lactone (glucono delta-lactone) with a calcium salt, such as calcium carbonate or calcium hydroxide. The purity and quality of the final product are paramount, necessitating strict adherence to pharmacopoeial standards and good manufacturing practices (GMP).

Key manufacturing considerations include:

• Raw Material Sourcing: High-purity gluconic acid and calcium sources are essential to minimize impurities. Suppliers must have robust supplier qualification programs.
• Reaction Control: Precise control of temperature, pH, and reaction time is critical to optimize yield and minimize byproduct formation.
• Purification: Multiple purification steps, including crystallization, filtration, and drying, are employed to achieve pharmaceutical-grade purity. Techniques like ion exchange chromatography may be utilized.
• Quality Control: Rigorous testing is performed at various stages of production, including assays for calcium content, heavy metals, residual solvents, microbial limits, and specific impurities as defined by pharmacopoeias.
• Particle Size Distribution: For certain pharmaceutical formulations, controlled particle size distribution is important for dissolution rates and handling. Manufacturers may offer different grades based on particle size.

Pharmacopoeial standards that govern calcium gluconate quality include:

• United States Pharmacopeia (USP): Specifies tests for identification, assay, pH, loss on drying, heavy metals, and arsenic.
• European Pharmacopoeia (EP): Similar specifications to USP, with potential variations in limits for certain impurities.
• Japanese Pharmacopoeia (JP): Provides additional or alternative testing requirements.
• Food Chemicals Codex (FCC): Relevant for food-grade applications, often overlapping with pharmaceutical requirements.

Manufacturers must demonstrate compliance with GMP guidelines established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. Certifications like ISO 9001 are common, indicating a commitment to quality management systems.

What are the Regulatory Requirements for Calcium Gluconate in Major Pharmaceutical Markets?

Regulatory compliance is non-negotiable for suppliers of active pharmaceutical ingredients (APIs) like calcium gluconate. Key regulatory considerations include:

• Drug Master Files (DMFs): Suppliers often submit DMFs to regulatory agencies (e.g., FDA, EMA) that contain detailed information about the manufacturing process, quality control, and facility. Pharmaceutical companies then reference these DMFs in their drug product applications.
• Facility Inspections: Manufacturing facilities are subject to regular inspections by regulatory authorities to ensure ongoing compliance with GMP.
• Pharmacopoeial Compliance: Products must meet the specifications outlined in the relevant pharmacopoeias of the target markets (USP, EP, JP).
• ICH Guidelines: Adherence to International Council for Harmonisation (ICH) guidelines, particularly ICH Q7 for GMP for APIs, is expected.
• REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals): For suppliers exporting to the European Union, compliance with REACH regulations is necessary.
• Country-Specific Registrations: Some countries may require specific product registrations or import permits.

For example, in the United States, the FDA reviews DMFs and inspects facilities. In Europe, the EMA and national competent authorities oversee API quality through GMP inspections and the review of Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs) issued by the EDQM.

What are the Market Dynamics and Supply Chain Considerations?

The market for calcium gluconate is influenced by demand from the pharmaceutical industry for use in intravenous solutions, oral supplements, and other medicinal products. Key market dynamics include:

• Growing Demand for Calcium Supplements: Increasing awareness of bone health and the prevalence of calcium deficiency drive demand for calcium-containing products.
• In-Vitro Diagnostics: Calcium gluconate is used in some diagnostic reagents.
• Geographic Concentration of Manufacturing: A significant portion of global production capacity resides in China and India, creating potential for supply chain concentration risk.
• Price Volatility: Raw material costs, energy prices, and global supply/demand imbalances can affect pricing.
• Quality and Reliability: Pharmaceutical companies prioritize suppliers with a proven track record of consistent quality, regulatory compliance, and reliable delivery.
• Lead Times: Sourcing calcium gluconate often involves significant lead times, particularly for international shipments.
• Supplier Audits: Pharmaceutical companies typically conduct thorough audits of potential suppliers' manufacturing sites and quality systems before establishing a supply agreement.
• Dual Sourcing: To mitigate supply chain risks, many pharmaceutical manufacturers pursue dual or multi-sourcing strategies for critical APIs.
• Impact of Trade Policies: Tariffs and trade disputes can influence sourcing decisions and costs.

The COVID-19 pandemic highlighted the vulnerabilities in global pharmaceutical supply chains, emphasizing the need for resilient sourcing strategies. Companies are increasingly looking for suppliers with strong business continuity plans and geographic diversification.

What are the Emerging Trends in Calcium Gluconate Production and Sourcing?

Emerging trends in calcium gluconate production and sourcing are driven by technological advancements, regulatory shifts, and evolving market demands.

• Greener Manufacturing Processes: There is growing interest in developing more sustainable and environmentally friendly manufacturing methods, potentially involving biocatalysis or optimized chemical synthesis routes to reduce waste and energy consumption.
• Continuous Manufacturing: While not yet widespread for calcium gluconate, the pharmaceutical industry is exploring continuous manufacturing for APIs, which could lead to improved efficiency, consistency, and reduced footprint.
• Advanced Analytical Techniques: Implementation of advanced analytical tools for impurity profiling and process monitoring can enhance product quality and regulatory compliance.
• Supply Chain Transparency and Traceability: Increased demand for end-to-end supply chain visibility, enabling better risk management and product authentication. Blockchain technology is being explored in this area.
• Regionalization of Supply Chains: A move towards diversifying manufacturing bases and potentially reshoring or nearshoring production to reduce reliance on single geographic regions. This is a long-term trend influenced by geopolitical factors and supply chain resilience concerns.
• Enhanced Quality Management Systems: Continuous improvement in quality management systems to meet increasingly stringent regulatory expectations and anticipate future compliance requirements.

Key Takeaways

The global supply of pharmaceutical-grade calcium gluconate involves a number of key manufacturers, primarily located in Asia, Europe, and North America. Quality and regulatory compliance are paramount, with adherence to USP, EP, and GMP standards being critical. Pharmaceutical companies must navigate complex regulatory landscapes, including DMF submissions and facility inspections. Market dynamics are influenced by growing health awareness and the need for reliable supply chains, prompting strategies such as dual sourcing and a focus on supplier resilience. Emerging trends point towards more sustainable manufacturing, enhanced supply chain transparency, and potential regionalization of production.

FAQs

1. What is the typical shelf life of pharmaceutical-grade calcium gluconate? Pharmaceutical-grade calcium gluconate typically has a shelf life of three to five years when stored under appropriate conditions (e.g., protected from light and moisture in well-sealed containers). Specific shelf-life information should be obtained from the individual manufacturer.

2. Are there significant price differences between calcium gluconate sourced from China versus Europe or the USA? Historically, sourcing from China has often presented a cost advantage due to lower labor and manufacturing overheads. However, factors such as quality control, regulatory compliance costs, shipping expenses, and currency fluctuations can influence the final price, narrowing the gap. Pharmaceutical companies prioritize consistent quality and supply reliability, which can sometimes outweigh marginal cost savings.

3. What are the main impurities to monitor in pharmaceutical-grade calcium gluconate? Key impurities to monitor include heavy metals (such as lead, arsenic, and mercury), residual solvents from the manufacturing process, and organic impurities derived from the starting materials or side reactions. Limits for these impurities are defined in pharmacopoeial monographs.

4. How does the particle size of calcium gluconate impact its use in pharmaceutical formulations? Particle size distribution is critical for the dissolution rate of the drug substance, which affects bioavailability. For oral solid dosage forms, it can also impact powder flow and compressibility during manufacturing. For injectable formulations, particle size must be controlled to prevent embolisms. Manufacturers often provide different grades with specified particle size ranges.

5. What is the significance of a Certificate of Suitability (CEP) for calcium gluconate? A Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) is issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM). It certifies that the quality of a substance is suitably controlled by the relevant monograph of the European Pharmacopoeia. For calcium gluconate intended for the European market, a CEP simplifies the regulatory dossier preparation for drug product marketing authorization applications.

Citations

[1] Jost Chemical Co. (n.d.). Calcium Gluconate. Retrieved from https://www.jostchemical.com/products/calcium-gluconate

[2] Ward Blenkinsop. (n.d.). Calcium Gluconate. Retrieved from https://www.wardblenkinsop.com/product/calcium-gluconate/

[3] Haorui Pharma-Tech Co., Ltd. (n.d.). Calcium Gluconate USP/EP. Retrieved from https://www.haoruipharma.com/calcium-gluconate/

[4] CCM (Chia Cheng Metal). (n.d.). Calcium Gluconate. Retrieved from http://www.ccm.com.tw/product_detail/Calcium_Gluconate.html

[5] Anhui Donghua Chemical Co., Ltd. (n.d.). Calcium Gluconate. Retrieved from http://www.donghuachem.com/en/product/calcium-gluconate/

[6] Shandong Xinhua Pharmaceutical Co., Ltd. (n.d.). Products. Retrieved from http://www.xhpc.com/en/products.html

[7] Jiangsu Jiujiu Pharmaceutical Co., Ltd. (n.d.). Products. Retrieved from http://www.jiujiupharma.com/Products-en.html

[8] Uquifa. (n.d.). Product Portfolio. Retrieved from https://www.uquifa.com/product-portfolio/

[9] Neuland Laboratories Ltd. (n.d.). APIs. Retrieved from https://www.neulandlabs.com/apis/

[10] United States Pharmacopeia. (2023). United States Pharmacopeia–National Formulary (USP–NF).

[11] European Directorate for the Quality of Medicines & HealthCare. (2023). European Pharmacopoeia (Ph. Eur.).

[12] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2022). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7.