Suppliers and packagers for generic pharmaceutical drug: CALCIUM ACETATE

CALCIUM ACETATE

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	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	201658	ANDA	Amneal Pharmaceuticals of New York LLC	53746-590-01	100 CAPSULE in 1 BOTTLE (53746-590-01)	2014-10-08
Amneal Pharms	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	201658	ANDA	Amneal Pharmaceuticals of New York LLC	53746-590-05	500 CAPSULE in 1 BOTTLE (53746-590-05)	2014-10-08
Amneal Pharms	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	201658	ANDA	Amneal Pharmaceuticals of New York LLC	53746-590-20	200 CAPSULE in 1 BOTTLE (53746-590-20)	2014-10-08
Chartwell Rx	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	091312	ANDA	Chartwell RX, LLC.	62135-191-22	200 CAPSULE in 1 BOTTLE (62135-191-22)	2018-06-29
Chartwell Rx	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	091312	ANDA	Chartwell RX, LLC.	62135-191-30	30 CAPSULE in 1 BOTTLE (62135-191-30)	2018-06-29
Chartwell Rx	CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	091312	ANDA	Chartwell RX, LLC.	62135-191-73	750 CAPSULE in 1 BOTTLE (62135-191-73)	2018-06-29

Calcium Acetate Pharmaceutical Suppliers Analysis

Last updated: February 19, 2026

Calcium acetate is a pharmaceutical ingredient used in the treatment of hyperphosphatemia in patients with chronic kidney disease. This analysis identifies key global suppliers, their manufacturing capabilities, and relevant regulatory information.

What are the Primary Pharmaceutical Applications of Calcium Acetate?

Calcium acetate functions as a phosphate binder. In individuals with chronic kidney disease (CKD), impaired kidney function leads to elevated serum phosphate levels, a condition known as hyperphosphatemia. This can cause secondary hyperparathyroidism, bone disease, and cardiovascular calcification. Calcium acetate binds to dietary phosphate in the gastrointestinal tract, forming insoluble calcium phosphate, which is then excreted in the feces. This mechanism lowers serum phosphate levels, mitigating the associated health risks.

The primary pharmaceutical formulations containing calcium acetate are oral tablets and capsules. Dosing is typically adjusted based on serum phosphate levels and dietary intake.

Who are the Leading Global Manufacturers and Suppliers of Calcium Acetate?

Several manufacturers globally produce pharmaceutical-grade calcium acetate. These suppliers cater to the needs of pharmaceutical companies for use in finished drug products.

• Anqiu Lexing Chemical Co., Ltd. (China): A significant producer of calcium acetate, focusing on industrial and pharmaceutical grades. The company has a substantial production capacity and exports globally.
• J.T.Baker (Avantor, USA): While Avantor offers a broad portfolio of chemicals, J.T.Baker branded products are known for high purity, often suitable for pharmaceutical applications.
• Merck KGaA (Germany): Through its MilliporeSigma life science business, Merck KGaA supplies a range of chemicals, including calcium acetate, often in smaller quantities for research and development or specialized pharmaceutical manufacturing.
• Nacalai Tesque, Inc. (Japan): A Japanese supplier of high-purity reagents and chemicals, Nacalai Tesque offers calcium acetate for laboratory and pharmaceutical use.
• Piedmont Chemical Industries, Inc. (USA): A US-based chemical manufacturer that produces various acetate salts, including calcium acetate, for diverse industrial and potential pharmaceutical applications.
• Spectrum Chemical Manufacturing Corp. (USA): Spectrum Chemical is a prominent supplier of fine chemicals, including USP/NF grade calcium acetate, catering to the pharmaceutical and biopharmaceutical industries. They offer various packaging sizes.
• VWR International (Avantor, USA): Similar to J.T.Baker, VWR, now part of Avantor, supplies a wide array of laboratory chemicals, including calcium acetate, for research and manufacturing purposes.

Table 1: Key Calcium Acetate Suppliers and Geographic Presence

Supplier Name	Country of Origin	Primary Product Grade Focus	Notes
Anqiu Lexing Chemical Co., Ltd.	China	Industrial, Pharmaceutical	Large-scale production, global exporter.
J.T.Baker (Avantor)	USA	High Purity, Reagent	Pharmaceutical and research applications.
Merck KGaA (MilliporeSigma)	Germany	Reagent, Specialty	Diverse chemical portfolio for R&D and manufacturing.
Nacalai Tesque, Inc.	Japan	High Purity, Reagent	Specializes in laboratory and pharmaceutical-grade chemicals.
Piedmont Chemical Industries, Inc.	USA	Industrial, Specialty	Manufacturer of various acetate salts.
Spectrum Chemical Mfg. Corp.	USA	USP/NF, Pharmaceutical	Focus on pharmaceutical excipients and active ingredients.
VWR International (Avantor)	USA	Reagent, Laboratory	Broad distribution of laboratory chemicals.

What are the Regulatory and Quality Standards for Pharmaceutical-Grade Calcium Acetate?

The quality and purity of calcium acetate intended for pharmaceutical use are critical. Suppliers must adhere to stringent regulatory standards to ensure patient safety and product efficacy.

• United States Pharmacopeia (USP) and National Formulary (NF): Pharmaceutical-grade calcium acetate in the U.S. must meet the specifications outlined in the USP/NF monographs. These standards define acceptable limits for impurities, assay, physical characteristics, and performance. For example, the USP monograph for Calcium Acetate specifies limits for arsenic, heavy metals, and loss on drying.
• European Pharmacopoeia (Ph. Eur.): Similar to the USP, the Ph. Eur. sets quality standards for pharmaceutical substances used in Europe. Calcium acetate intended for the European market must comply with its monograph.
• Good Manufacturing Practices (GMP): Manufacturers producing Active Pharmaceutical Ingredients (APIs) and excipients must operate under GMP guidelines. This ensures consistent quality, traceability, and control throughout the manufacturing process. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) audit manufacturing facilities to ensure GMP compliance.
• Drug Master Files (DMFs): Suppliers of pharmaceutical-grade calcium acetate often maintain DMFs with regulatory agencies (e.g., FDA). A DMF provides confidential detailed information about manufacturing facilities, processes, and quality control measures for a drug substance. Pharmaceutical companies can reference these DMFs in their drug product applications.

Table 2: Key Regulatory Standards for Pharmaceutical Calcium Acetate

Standard/Guideline	Issuing Body	Scope	Relevance to Calcium Acetate
USP/NF Monograph	United States Pharmacopeia	Specifications for identity, purity, strength, and quality of drug substances and dosage forms.	Defines acceptable impurity limits, assay methods, and physical tests.
European Pharmacopoeia (Ph. Eur.)	European Directorate for the Quality of Medicines & HealthCare (EDQM)	Similar to USP/NF, for substances used in medicinal products in Europe.	Sets quality standards for calcium acetate in the European market.
Good Manufacturing Practices (GMP)	FDA, EMA, WHO, etc.	Principles and procedures for manufacturing and quality control to ensure product safety and efficacy.	Mandated for API and excipient production facilities.
Drug Master File (DMF)	FDA, Health Canada, etc.	Confidential detailed information on manufacturing of drug substances.	Facilitates regulatory review of drug product applications.

What are the Technical Specifications and Purity Requirements?

Pharmaceutical-grade calcium acetate must meet precise technical specifications to ensure its suitability for medicinal use.

• Assay: The calcium acetate content is typically specified within a narrow range, often 97.0% to 102.0% on a dried basis, depending on the pharmacopeia. This ensures the correct amount of active ingredient.
• Impurities: Limits are set for various potential impurities, including:
  • Heavy Metals: Typically not more than 10 or 20 parts per million (ppm).
  • Arsenic: Generally limited to 3 ppm or less.
  • Chloride: Specified limits, e.g., not more than 0.05%.
  • Sulfate: Specified limits, e.g., not more than 0.1%.
  • Magnesium and Alkali Metals: Limits are set to ensure the absence of excessive contamination.
• Loss on Drying: This measures the volatile matter content, usually not exceeding 5.0% or 8.0%, indicating the substance's dryness.
• pH: The pH of a solution of calcium acetate (e.g., a 5% w/v solution) is typically required to be within a specific range, such as 6.0 to 9.0, indicating its chemical stability and suitability for formulation.
• Physical Appearance: Pharmaceutical-grade calcium acetate is usually described as a white, odorless, crystalline powder.

Table 3: Typical Specifications for Pharmaceutical-Grade Calcium Acetate (USP Reference)

Test	Specification Example (USP)	Unit
Assay (as Ca(CH₃COO)₂)	97.0 – 102.0	%
Loss on Drying	Not more than 8.0	%
Heavy Metals	Not more than 20	ppm
Arsenic	Not more than 3	ppm
Chloride	Not more than 0.05	%
Sulfate	Not more than 0.1	%
pH (5% solution)	6.0 – 9.0
Appearance	White crystalline powder

These specifications are crucial for ensuring batch-to-batch consistency, preventing adverse reactions in patients, and meeting regulatory requirements for drug product approval. Suppliers must provide Certificates of Analysis (CoAs) with each batch, detailing the results of tests performed against these specifications.

What are the Supply Chain Considerations and Risks?

The supply chain for pharmaceutical-grade calcium acetate involves several considerations and potential risks that can impact availability and cost.

• Geographic Concentration of Manufacturing: A significant portion of bulk chemical manufacturing, including calcium acetate, is concentrated in Asia, particularly China. This concentration can create vulnerabilities related to geopolitical events, trade disputes, or localized disruptions (e.g., environmental regulations impacting production).
• Raw Material Sourcing: The production of calcium acetate relies on basic chemicals like acetic acid and calcium sources. Fluctuations in the availability or cost of these raw materials can affect calcium acetate pricing and supply.
• Quality Control and Audits: Pharmaceutical companies must conduct rigorous quality assessments and audits of their calcium acetate suppliers to ensure compliance with GMP and pharmacopeial standards. This process can be resource-intensive and time-consuming.
• Regulatory Changes: Evolving regulatory requirements in different markets can necessitate changes in manufacturing processes or analytical testing, potentially impacting supplier qualifications and lead times.
• Logistics and Transportation: The global nature of the supply chain requires robust logistics for timely and secure delivery, maintaining product integrity during transit.
• Dual Sourcing Strategy: To mitigate risks associated with single-supplier dependency, pharmaceutical companies often adopt a dual or multi-sourcing strategy. This involves qualifying at least two suppliers to ensure continuity of supply in case of disruptions.
• Supplier Viability: The financial stability and long-term operational capacity of suppliers are critical. Pharmaceutical companies assess supplier viability to ensure reliable, long-term partnerships.

Companies utilizing calcium acetate in their drug products must proactively manage these supply chain dynamics through careful supplier selection, contract negotiation, and ongoing risk assessment.

What are the Future Trends in Calcium Acetate Supply?

Future trends in the calcium acetate market will likely be shaped by evolving healthcare demands, regulatory landscapes, and technological advancements.

• Increased Demand from Aging Populations and CKD Prevalence: The global aging population and the rising incidence of chronic kidney disease are expected to drive sustained demand for phosphate binders like calcium acetate.
• Focus on Supply Chain Resilience: Following recent global events, there is an intensified focus on building more resilient and diversified supply chains. This may lead to a gradual shift towards more geographically distributed manufacturing or a greater emphasis on regional supply hubs.
• Advancements in Manufacturing Processes: Suppliers may invest in process improvements to enhance purity, reduce environmental impact, and optimize cost-efficiency. This could include continuous manufacturing techniques or greener chemistry approaches.
• Stricter Regulatory Scrutiny: Regulatory agencies are likely to maintain or increase scrutiny on the quality and manufacturing of APIs and excipients, potentially requiring suppliers to invest further in quality systems and data integrity.
• Emergence of New Phosphate Binders: While calcium acetate remains a cornerstone therapy, ongoing research into novel phosphate binders with potentially improved efficacy or fewer side effects could influence market dynamics over the long term. However, the established cost-effectiveness and therapeutic profile of calcium acetate suggest its continued prominence.
• Digitalization of Supply Chain Management: Increased adoption of digital tools for supply chain visibility, traceability, and risk management will become more prevalent, allowing for better oversight and quicker response to potential issues.

These trends indicate a dynamic market where reliable supply, stringent quality adherence, and adaptive strategies will be paramount for both suppliers and pharmaceutical manufacturers.

Key Takeaways

• Calcium acetate is a critical phosphate binder used in managing hyperphosphatemia in chronic kidney disease patients.
• Key global suppliers are located in China, the USA, and Germany, with varying focuses on pharmaceutical grade purity.
• Adherence to USP, Ph. Eur., and GMP standards is mandatory for pharmaceutical-grade calcium acetate.
• Technical specifications include defined limits for assay, impurities, loss on drying, and pH.
• Supply chain risks include geographic concentration of manufacturing, raw material volatility, and regulatory changes.
• Future trends point to sustained demand, increased focus on supply chain resilience, and ongoing regulatory scrutiny.

Frequently Asked Questions

1. What is the typical purity level required for pharmaceutical-grade calcium acetate? Pharmaceutical-grade calcium acetate must meet pharmacopeial standards, typically specifying an assay between 97.0% and 102.0% on a dried basis, with strict limits on impurities like heavy metals and arsenic.

2. Which regulatory bodies oversee the quality of calcium acetate suppliers? Suppliers are overseen by national regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which enforce Good Manufacturing Practices (GMP) and review compliance with pharmacopeial monographs (USP, Ph. Eur.).

3. What are the primary raw materials used in the production of calcium acetate? The primary raw materials for calcium acetate production are acetic acid and a calcium source, such as calcium hydroxide or calcium carbonate.

4. How do pharmaceutical companies ensure the quality of calcium acetate from their suppliers? Pharmaceutical companies ensure quality through supplier qualification processes, which include audits of manufacturing facilities, review of Drug Master Files (DMFs), verification of Certificates of Analysis (CoAs) for each batch, and independent testing.

5. What is the primary mechanism by which calcium acetate treats hyperphosphatemia? Calcium acetate binds to dietary phosphate in the gastrointestinal tract, forming insoluble calcium phosphate. This complex is then eliminated from the body in the feces, thereby reducing the absorption of phosphate and lowering serum phosphate levels.

Citations

[1] United States Pharmacopeial Convention. (2023). United States Pharmacopeia and National Formulary (USP-NF). Author. [2] European Directorate for the Quality of Medicines & HealthCare. (2023). European Pharmacopoeia (Ph. Eur.). Author. [3] Food and Drug Administration. (n.d.). Good Manufacturing Practice (GMP) for Drugs. Retrieved from [FDA website] [4] Anqiu Lexing Chemical Co., Ltd. (n.d.). Product Information: Calcium Acetate. Retrieved from company website. [5] Spectrum Chemical Mfg. Corp. (n.d.). Calcium Acetate, USP/NF. Retrieved from company website.