Bulk Pharmaceutical API Sources for PROCALAMINE

Bulk Pharmaceutical API Sources for PROCALAMINE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		KIXEFQe\APByw]`R`JcSP@@
MP Biomedicals		201796
NovoSeek		6116
NovoSeek		517040
MP Biomedicals		193820
ABI Chem		AC1L1LU9
ABI Chem		AC1LANU5

Bulk Active Pharmaceutical Ingredient (API) Sources for Procalamine

Last updated: July 29, 2025

Introduction

Procalamine, a calcium-based pharmaceutical additive, is integral in various medical and industrial applications, including pharmaceutical formulations, food processing, and water treatment. The active ingredient, typically calcium carbonate or calcium hydroxide, is sourced from numerous global suppliers specializing in high-purity, pharmaceutical-grade APIs. Securing reliable bulk sources is critical for pharmaceutical companies aiming for compliance, cost-effectiveness, and supply security. This analysis explores the global landscape of API suppliers for Procalamine, focusing on calcium-based compounds used as the active component.

Understanding Procalamine: Composition and Applications

Procalamine's primary active component is calcium carbonate (CaCO₃), with calcium hydroxide (Ca(OH)₂) also serving as an active ingredient in certain formulations. These compounds are employed for their neutralizing, supplementing, and buffering properties. Their uses span:

• Pharmaceuticals: as calcium supplements and antacids.
• Food industry: as food additive E170 (calcium carbonate).
• Water treatment: for pH adjustment and neutralization.
• Industrial applications: as fillers and anti-caking agents.

Ensuring the API's pharmaceutical-grade purity necessitates sourcing from certified suppliers adhering to standards like USP, EP, or BP.

Global API Suppliers for Calcium Carbonate and Hydroxide

1. Major Pharmaceutical-Grade Calcium Carbonate Suppliers

a) Omya AG (Switzerland)

• Overview: Omya, a leading global producer, supplies pharmaceutical-grade calcium carbonate with strict compliance to pharmacopeial standards.
• Strengths: High purity, extensive quality control, and global distribution network.
• Applications: Used in pharmaceuticals, food grade, and nutraceuticals.

b) Imerys Group (France)

• Overview: Imerys produces high-purity calcium carbonates suitable for pharmaceutical applications.
• Strengths: Consistency in quality, scalable manufacturing, compliance with international standards.
• Application: Widely used in antacid formulations and calcium supplements.

c) Specialty Minerals Inc. (SMI, USA)

• Overview: A division of Minerals Technologies Inc., SMI offers pharmaceutical-grade calcium carbonate.
• Strengths: Reliable supply chain, dedicated pharmaceutical grades, extensive R&D support.
• Uses: Food, pharmaceutical, and personal care industries.

2. Key Suppliers of Calcium Hydroxide for Pharmaceutical Use

a) Merck KGaA (Germany)

• Overview: Known for producing high-purity calcium hydroxide for pharmaceutical and laboratory applications.
• Certifications: USP, EP, and other pharmacopeial standards.
• Uses: As an active ingredient in neutralization and buffering agents.

b) JT Baker (Avantor, USA)

• Overview: Supplies calcium hydroxide powders meeting pharmaceutical-grade specifications.
• Strengths: Consistent quality, global logistics, and comprehensive product documentation.
• Applications: Used in pharmaceutical manufacturing and laboratory research.

c) Kemira (Finland)

• Overview: Offers specialty chemicals including pharmaceutical-grade calcium hydroxide.
• Strengths: Superior purity, customized grades, strong regulatory compliance.
• Applications: Water treatment, pharmaceutical manufacturing.

3. Asia-Pacific API Sources

a) Maruti Chem (India)

• Overview: Manufactures calcium carbonate and calcium hydroxide adhering to pharmacopeial standards.
• Strengths: Cost-effective production, growing export footprint.
• Certifications: ISO, WHO-GMP certification.

b) Yinzheng Chemical (China)

• Overview: Offers calcium carbonate and hydroxide with pharmaceutical quality parameters.
• Strengths: Competitive pricing, rapid supply chain, extensive manufacturing capacity.

4. Latin America API Suppliers

a) Brasil Mineral (Brazil)

• Overview: Supplies pharmaceutical-grade calcium carbonate from local mineral resources.
• Strengths: Cost advantages and strong regional presence.
• Applications: Local pharmaceutical manufacturers and water treatment.

Considerations in Selecting API Suppliers

• Regulatory Compliance: Suppliers must adhere to USP, EP, BP standards or relevant pharmacopeias.
• Purity and Quality Control: High uniformity and low impurity levels are critical for pharmaceutical APIs.
• Certifications: GMP, ISO, and cGMP compliance facilitate acceptance by regulatory agencies.
• Supply Chain Stability: Long-term relationships, logistics capabilities, and capacity to scale are vital.
• Cost and Lead Time: Balancing cost-effectiveness with delivery reliability.

Quality Assurance and Validation

Suppliers with GxP certifications provide comprehensive documentation including batch records, Certificates of Analysis (CoA), and stability data. Rigorous qualification and auditing processes are essential to validate API sources before scaling manufacturing.

Emerging Trends and Future Outlook

The demand for pharmaceutical-grade calcium carbonate and hydroxide continues to rise, driven by expanding global healthcare markets and increased use in generic drug manufacturing. Suppliers investing in green chemistry, sustainable mining practices, and advanced purification technologies are positioning themselves competitively. Additionally, Asia-Pacific suppliers are expanding capacity to meet rising regional demand, offering cost advantages.

Risks and Mitigation

Supply disruptions due to geopolitical issues, environmental regulations, or natural disasters pose risks. Diversification of sources, establishing strategic partnerships, and maintaining buffer stock are strategies to mitigate these risks.

Conclusion

Securing a reliable API source for Procalamine requires careful consideration of supplier quality, compliance, capacity, and cost. Leading international companies such as Omya, Imerys, Merck, and Avantor offer high-quality pharmaceutical-grade calcium carbonate and hydroxide, ensuring consistency and regulatory compliance. Growth in emerging markets and advances in manufacturing processes will likely expand the supplier landscape, offering additional opportunities and challenges.

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Key Takeaways

• Identify reputable, certified suppliers such as Omya, Imerys, Merck, and Avantor for pharmaceutical-grade calcium carbonate and hydroxide.
• Prioritize compliance with pharmacopeial standards (USP, EP, BP) and verify certifications to ensure API quality.
• Evaluate supply chain reliability and capacity to prevent disruptions in the procurement of Procalamine's active ingredients.
• Monitor emerging markets and technological advancements for cost-effective and sustainable sourcing options.
• Implement rigorous qualification processes and maintain supplier audits to uphold quality assurance in pharmaceutical applications.

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FAQs

1. What are the primary raw materials used as APIs in Procalamine?
Calcium carbonate and calcium hydroxide serve as the principal active ingredients in Procalamine, offering neutralizing and buffering properties essential for its applications.

2. How do I verify if a calcium carbonate supplier meets pharmaceutical standards?
Request Certificates of Analysis (CoA), confirm GMP and ISO certifications, and perform supplier audits. Suppliers like Omya and Imerys routinely provide documentation aligning with USP, EP, or BP standards.

3. Are there regional differences in API sourcing for Procalamine?
Yes. North America and Europe host well-established suppliers with extensive certifications, while Asia-Pacific markets offer cost-effective options with increasing compliance standards. Both regions are viable depending on regulatory requirements and supply chain considerations.

4. What risks are associated with sourcing calcium-based APIs globally?
Risks include supply chain disruptions, quality inconsistencies, regulatory non-compliance, and geopolitical issues. Diversification, supplier qualification, and strategic stockpiling mitigate these risks.

5. How is sustainability impacting API sourcing for Procalamine?
Sustainable mining practices, eco-friendly purification technologies, and corporate social responsibility initiatives are increasingly influencing supplier selection, aligning with regulatory and market expectations for environmentally responsible products.

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References

[1] Omya AG, "Pharmaceutical Calcium Carbonate," Omya Product Portfolio, 2022.
[2] Imerys Group, "High Purity Calcium Carbonates," Imerys Resources, 2022.
[3] Minerals Technologies Inc., "Specialty Minerals Division," 2022.
[4] Merck KGaA, "Pharmaceutical Grade Chemicals," Merck Product Data Sheets, 2022.
[5] Avantor, "Chemicals and Reagents," 2022.