Bulk Pharmaceutical API Sources for PHOSLO GELCAPS

Bulk Pharmaceutical API Sources for PHOSLO GELCAPS

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		KIXEFQe\APByw]`R`JcSP@@
MP Biomedicals		201796
NovoSeek		6116

Bulk Active Pharmaceutical Ingredient (API) Sources for PHOSLO GELCAPS

Last updated: August 2, 2025

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Introduction

Phoslo Gelcaps, recognized scientifically as calcium acetate, are primarily prescribed to manage hyperphosphatemia in patients with chronic kidney disease (CKD). With rising demand for these phosphate binders, the global supply chain hinges critically on credible bulk API sources. Ensuring reliable and compliant API sourcing is vital for pharmaceutical companies seeking to manufacture PHOSLO Gelcaps consistently and in accordance with regulatory standards.

Understanding the API: Calcium Acetate

Calcium acetate serves as the active pharmaceutical ingredient (API) in PHOSLO Gelcaps. It functions by binding dietary phosphate in the gastrointestinal tract, thus preventing its absorption into the bloodstream. The purity, stability, and bioavailability of calcium acetate API directly influence the efficacy and safety of the final pharmaceutical product.

Global API Manufacturing Regions

The supply of calcium acetate API is concentrated primarily in Asia, Europe, and North America. Manufacturers in these regions abide by varying regulatory standards, with European and North American producers often adhering to stringent GMP (Good Manufacturing Practices).

Asia-Pacific API Suppliers

• China: Dominates the global calcium acetate API production landscape, providing cost-effective bulk supply. Leading manufacturers such as Jiangsu Jiangshan Pharmaceutical Co. and Shandong Ailitong Pharmaceutical Co. deliver GMP-compliant APIs.

• India: Emerging as a significant player with companies like Sancus Pharma and Gujarat Alkalies and Chemicals Ltd. producing high-purity calcium acetate APIs accessible for international markets.

European API Manufacturers

• EU-based firms such as Sarepta Therapeutics (through licensed manufacturing partners) meet high regulatory standards, supplying APIs for export to North America and global markets.

• Germany and Italy lead in specialized chemical synthesis, ensuring API integrity and consistent quality.

North American API Suppliers

• Stellar Formulations and Amneal Pharmaceuticals provide APIs manufactured under FDA regulations, crucial for market segments demanding high compliance standards.

Key Criteria for Selecting API Suppliers

• Regulatory Compliance: Suppliers must meet USP, EP, or other relevant pharmacopoeia standards, with documented GMP adherence.

• Quality Certifications: ISO 9001, ISO 13485, and certifications specifically related to pharmaceutical APIs are essential.

• Supply Chain Reliability: Consistent production capacity and logistical robustness reduce risk of shortages.

• Analytical Data and Certificates of Analysis (CoA): Transparency in impurity profiling and validation data supports quality assurance.

Major API Suppliers for Calcium Acetate API

Supplier Name	Region	Certification & Compliance	Notes
Jiangsu Jiangshan Pharmaceutical Co.	China	GMP, ISO 9001	Large-scale production, cost-effective
Gujarat Alkalies and Chemicals Ltd.	India	GMP, ISO 9001	Established electrolyte and API producer
Sancus Pharma	India	GMP, WHO-GMP, ISO 9001	Growing international reputation
Stel Pharma	Europe	GMP, ISO 13485, EC-certified	High purity APIs for niche markets
Amneal Pharmaceuticals	North America	FDA-approved facilities, GMP	Reliable US supplier

Supply Chain Challenges and Considerations

1. Regulatory Escalation: Increasing global scrutiny on API manufacturing facilities—especially post-2020—necessitates rigorous audits and documentation.

2. Geopolitical Influences: Tariffs, sanctions, or export restrictions can impact API import-export dynamics, emphasizing the importance of diversifying supplier bases.

3. Raw Material Availability: The stability of calcium sources and chemical synthesis inputs influences API supply stability.

4. Intellectual Property & Patent Rights: While calcium acetate is a generic compound, procedural patents or proprietary manufacturing processes may restrict procurement options.

Implications for Pharmaceutical Manufacturers

• Establish contracts with multiple suppliers to mitigate supply disruptions.

• Prioritize suppliers certifying adherence to pharmacopoeial standards and possessing robust quality assurance systems.

• Incorporate long-term supply agreements to stabilize procurement and costs.

• Conduct periodic audits and analytical verifications to ensure API batch compliance.

Future Outlook and Trends

The API sourcing landscape for calcium acetate is poised for growth driven by increasing CKD prevalence globally. Advances in green synthesis and process optimization may reduce reliance on traditional manufacturing hubs, expanding the diversity of suppliers. Additionally, compliance with evolving international standards will remain central to supply chain integrity.

Key Takeaways

• The core API for PHOSLO Gelcaps, calcium acetate, is mainly sourced from Asia, Europe, and North America, with China and India being dominant manufacturing hubs.

• Regulatory compliance, quality certifications, supply reliability, and transparent analytical data are critical when selecting API suppliers.

• Diversification of API sources mitigates geopolitical and supply chain risks; establishing strong supplier relationships is essential.

• Continuous monitoring of regulatory standards and process advancements will be necessary to maintain supply chain stability.

• Companies should prepare for potential regulatory shifts and ensure their API sources meet the latest quality and compliance standards.

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Frequently Asked Questions (FAQs)

1. What are the primary quality certifications to look for in API suppliers of calcium acetate?
Suppliers should hold GMP certification alongside compliance with pharmacopoeial standards such as USP or EP. Certifications like ISO 9001 and ISO 13485 further affirm quality management systems.

2. Are there regional differences in the quality of calcium acetate APIs?
Yes. While Chinese and Indian suppliers offer cost-effective APIs, European and North American manufacturers often adhere to stricter regulatory standards, impacting quality assurance levels.

3. How does supply chain diversification benefit API procurement?
It reduces dependence on a single supplier or region, mitigating risks associated with geopolitical issues, manufacturing disruptions, or regulatory changes.

4. What is the typical lead time for sourcing calcium acetate API?
Lead times vary but generally range from 4 to 12 weeks, contingent on supplier location, volume, and regulatory approval processes.

5. How can pharmaceutical companies verify API quality before manufacturing?
By reviewing Certificates of Analysis, conducting in-house or third-party analytical testing, and auditing supplier facilities in compliance with regulatory standards.

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Sources

[1] U.S. Pharmacopeia Convention, USP Monographs, Calcium Acetate.
[2] European Pharmacopoeia, Calcium Acetate Monograph.
[3] Industry Reports on API Market Trends, Global Pharma Insights, 2022.
[4] Supplier websites and compliance brochures (as of 2023).
[5] Regulatory guidelines from the FDA, EMA, and WHO on pharmaceutical API manufacturing and sourcing.

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Note: The details herein are subject to change based on regulatory updates, market dynamics, and technological advancements.