Bulk Pharmaceutical API Sources for ORAGRAFIN CALCIUM

Bulk Pharmaceutical API Sources for ORAGRAFIN CALCIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		1151-11-7
MuseChem		M050403
THE BioTek		bt-1184155
J&H Chemical Co.,ltd		JH71853
RR Scientific		R027474
EvitaChem		evt-1184155
Alfa Chemistry		ACM1151117

Last updated: July 28, 2025

lk Active Pharmaceutical Ingredient (API) Sources for: ORAGRAFIN CALCIUM

Introduction
Oragrafin Calcium, a radiopaque contrast agent primarily used in gastrointestinal imaging, is composed of barium sulfate with calcium salts to improve stability and imaging quality. Secure and reliable sourcing of its active pharmaceutical ingredient (API) is crucial for pharmaceutical manufacturers, imaging service providers, and wholesalers. Ensuring quality, regulatory compliance, and supply chain robustness are central to API procurement strategies. This article examines key sources and considerations for sourcing Oragrafin Calcium API globally, focusing on manufacturer profiles, supply chain dynamics, regulatory landscape, and quality assurance.

Understanding Oragrafin Calcium API Composition
Oragrafin Calcium combines barium sulfate with calcium salts, predominantly used as a contrast medium. Its API component, Barium Sulfate, is an inorganic non-absorbable radiopaque agent with high density, facilitating contrast in imaging procedures. Manufacturers often produce API-grade barium sulfate tailored for pharmaceutical applications, requiring strict adherence to pharmacopeial standards such as USP (United States Pharmacopeia) and BP (British Pharmacopoeia).

Global API Suppliers of Barium Sulfate for Medical Applications
The primary API sourcing involves specialized chemical manufacturers with expertise in inorganic compounds and pharmaceutical-grade production. Several global players dominate this sector, with varying capacities, quality standards, and regulatory registrations.

Leading API Manufacturers for Barium Sulfate (Active Ingredient in Oragrafin Calcium)

1. Sakai Chemical Industry Co., Ltd.

• Overview: A Japanese company with over a century of experience, Sakai Chemical is a recognized producer of high-purity barium sulfate, serving the pharmaceutical, diagnostics, and industrial sectors.
• API Quality Standards: Offers pharmaceutical-grade barium sulfate compliant with USP and EP standards.
• Supply Chain: Robust distribution in Asia, with global exports backed by long-term supply agreements.

2. Tosoh Corporation

• Overview: A diversified Japanese chemical manufacturer, Tosoh supplies high-quality inorganic compounds, including pharmaceutical-grade barium sulfate.
• Regulatory Compliance: Meets stringent pharmacopeial standards, suitable for injectable and oral contrast media.
• Research & Development: Ongoing innovations in particle size and purity enhancements.

3. Solvay

• Overview: A Belgian chemical firm with a strong presence in specialty chemicals and inorganic intermediates, Solvay supplies pharmaceutical-grade barium sulfate globally.
• Quality Credentials: Holds numerous regulatory approvals; their API-grade barium sulfate conforms to international pharmacopeias.
• Global Reach: Extensive distribution network covering North America, Europe, Asia, and emerging markets.

4. E. I. du Pont de Nemours and Company (DuPont)

• Overview: A legacy chemical manufacturer offering pharmaceutical-grade inorganic compounds, including barium sulfate.
• Standards and Certifications: Certified for compliance with International Pharmaceutical standards.
• Supply Capacity: Capable of large-volume supply suitable for manufacturing and bulk distribution.

5. Guanxi Huishengyi Chemical Industry Co., Ltd.

• Overview: A Chinese chemical producer specializing in inorganic minerals, including pharmaceutical-grade barium sulfate.
• Market Position: Cost-effective supplier with increasing regulatory recognition for quality standards.
• Regulatory Status: Engages in compliance with CFDA and international certifications, though verification remains essential for certain markets.

Regional Variations and Supply Considerations

• Asia-Pacific: Dominated by Chinese and Japanese suppliers, offering competitive pricing and high-quality products. Manufacturers such as Guanxi Huishengyi demonstrate rapid growth due to government policies favoring chemical exports.
• Europe: Established players like Solvay and Tosoh provide rigorous quality assurance and regulatory compliance, appealing to markets with strict pharmacopeial requirements.
• North America: U.S. suppliers like DuPont offer reliable API sources, often with comprehensive documentation and adherence to FDA standards.

Key Factors in Selecting API Suppliers

• Quality Assurance and Regulatory Compliance
  Ensure suppliers possess necessary certifications, including GMP (Good Manufacturing Practice), ISO standards, and pharmacopeial approvals. Confirm batch-to-batch consistency through Certificates of Analysis (CoA).

• Supply Capacity and Lead Times
  Evaluate the supplier's ability to meet demand fluctuations, especially amid global supply chain disruptions. Long-term relationships and strategic stockpiles can mitigate risks.

• Pricing and Contract Terms
  Balance cost considerations with quality and regulatory requirements. Negotiate flexible terms for volume, delivery schedules, and validation support.

• Regulatory Support and Documentation
  Confirm compliance documentation, including registration dossiers, safety data sheets, and validation data, especially for regulators like the FDA, EMA, or China CFDA.

Regulatory Landscape for Oragrafin Calcium API

Regulatory approval hinges on the source of Barium Sulfate API meeting pharmacopeial standards applicable in target markets. The U.S. FDA, EMA, and other agencies require rigorous validation, including impurity profiles and stability data. Manufacturers often rely on certified suppliers to ensure conformity and facilitate registration processes. Suppliers with established regulatory track records streamline market entry.

Supply Chain and Logistics Challenges

Global disruptions—ranging from geopolitical tensions to pandemics—impact API sourcing. Manufacturers should diversify supplier base, incorporate regional sourcing, and maintain safety stock. Traceability and transparent documentation bolster regulatory compliance and mitigate contamination risks.

Emerging Trends in API Sourcing for Contrast Agents

• Sustainability and Green Manufacturing: Increasing emphasis on environmentally responsible processes influences supplier selection.
• Technological Innovations: Advances in particle size control, coating, and functionalization improve API efficacy and safety profiles.
• Regulatory Harmonization: Efforts to align standards across regions simplify international supply chains and facilitate market access.

Conclusion

Securing reliable sources of the API for Oragrafin Calcium, primarily Barium Sulfate, requires diligent supplier evaluation rooted in quality, regulatory compliance, and supply chain resilience. Established global manufacturers like Sakai Chemical, Tosoh, and Solvay stand out for their high standards and extensive regulatory support. Chinese and regional suppliers offer cost-effective options but necessitate rigorous quality validation. Partnering with reputable suppliers aligned with international standards ensures consistent production, regulatory approval, and ultimately, patient safety.

---

Key Takeaways

• Prioritize suppliers with proven regulatory compliance, GMP certification, and consistent quality control measures.
• Diversify supply sources geographically to mitigate geopolitical and logistical risks.
• Engage suppliers early for technical validation and documentation support aligned with pharmaceutical regulatory frameworks.
• Monitor industry trends, particularly sustainability and technological advancements, influencing API manufacturing.
• Establish transparent communication channels and long-term relationships to secure supply continuity.

---

FAQs

1. What are the critical quality attributes to verify in Barium Sulfate API suppliers for Oragrafin Calcium?
Critical attributes include high purity, controlled particle size, low impurity levels, compliance with pharmacopeial standards (USP, BP), and comprehensive Certificates of Analysis.

2. How can manufacturers ensure the regulatory compliance of API sources globally?
Manufacturers should select suppliers with verified GMP certification, documented quality management systems, and proven compliance with regional pharmacopeial and pharmacopoeial standards. Engaging in supplier audits and requesting detailed validation batches further reinforces compliance.

3. Are regional suppliers like China-based barium sulfate producers suitable for pharmaceutical-grade API?
Yes, many Chinese suppliers produce pharmaceutical-grade barium sulfate meeting international standards, but due diligence, verification of certifications, and regulatory validation are essential before procurement.

4. What risks are associated with sourcing API from emerging markets, and how can they be mitigated?
Risks include inconsistent quality, regulatory non-compliance, and supply disruptions. These can be mitigated by rigorous supplier qualification, quality audits, contractual quality agreements, and maintaining safety stock levels.

5. How do technological innovations influence the sourcing of Barium Sulfate API?
Innovations such as nano-sized particles, coated formulations, and improved purity enhance API effectiveness and safety, making sourcing from advanced manufacturing facilities critical for high-quality contrast media production.

---

Sources
[1] European Pharmacopoeia, "Barium Sulfate," 2022 Edition.
[2] U.S. Pharmacopeia, "Barium Sulfate Monograph," USP 45, 2022.
[3] Sakai Chemical Industry Co., Ltd., Product Literature.
[4] Tosoh Corporation, Technical Data Sheets.
[5] Solvay S.A., Product Catalog, High Purity Barium Sulfate.