Bulk Pharmaceutical API Sources for GALLIUM CITRATE GA-67

Bulk Pharmaceutical API Sources for GALLIUM CITRATE GA-67

Vendor	Vendor Homepage	Vendor Sku	API Url
Alfa Chemistry		41183-64-6
J&H Chemical Co.,ltd		JH293099
RR Scientific		R213707
Alfa Chemistry		ACM41183646

Bulk Active Pharmaceutical Ingredient (API) Sources for Gallium Citrate Ga-67

Last updated: July 30, 2025

---

Introduction

Gallium-67 citrate (Ga-67 citrate) is a radiopharmaceutical used primarily in nuclear medicine for diagnostic imaging, including detecting infections, tumors, and lymphomas. As a specialty radiotracer, its production involves sourcing high-purity gallium citrate, which requires precise manufacturing under stringent quality controls. Understanding the landscape of bulk API sources for Ga-67 citrate is crucial for pharmaceutical companies, healthcare providers, and radiopharmacies seeking reliable suppliers and optimizing their supply chains.

---

Understanding Gallium-67 Citrate API

Gallium-67 (Ga-67) is a radioisotope with a half-life of approximately 78 hours, emitting gamma radiation suitable for scintigraphy imaging. The citrate complexation improves bioavailability and targeting efficiency. Due to its radiological properties, the API synthesis involves:

• Production of the Gallium-67 isotope: Typically generated via cyclotron irradiation of enriched zinc-68 targets or from molybdenum generators.
• Chemical complexation with citrate: Achieved through controlled chemical processes to produce well-defined, sterile, and pyrogen-free APIs suitable for radiolabeling.

As an active pharmaceutical ingredient, the API must comply with regulatory standards such as USP, EP, or Ph. Eur., ensuring purity, sterility, and stable isotope content.

---

Sources of Gallium-67 Citrate API

1. Specialized Radiopharmaceutical Manufacturers

Most bulk Ga-67 citrate APIs are produced by a handful of pharmaceutical companies specializing in radiochemistry, radioisotope supply, and radiopharmaceutical production. These firms often operate under Good Manufacturing Practice (GMP) compliance, catering to hospital radiopharmacies and centralized radiopharmacies.

• Mallinckrodt Pharmaceuticals: Historically among the key suppliers, Mallinckrodt has supplied Ga-67 for decades, often providing bulk isotopes and ready-to-label kits. Their global reach and adherence to strict regulatory standards make them a reliable source for bulk API.

• Curium Pharma (Part of IBA Group): Known for producing various medical isotopes, including gallium isotopes. They offer high-purity Ga-67 generators and process their own APIs, potentially providing bulk citrate complexes.

• Eckert & Ziegler: Active in supply of radioisotopes, including Ga-67, with capabilities to produce targeted bulk radiopharmaceuticals for research and clinical use, including APIs.

2. Isotope Suppliers and Radionuclide Laboratories

Some suppliers specialize in the bulk production of radioisotopes, including Ga-67, which can be further complexed with citrate in licensed facilities.

• IRL (Iso-Temp): Provides high-current cyclotron-produced gallium isotopes, primarily Ga-67, which can be supplied as raw material or as complexed API after specialized processing.

• TRASIS (Transaction Radiopharmaceuticals & Isotope Services, Inc.): Offers Ga-67 generators and raw isotopic materials, which can be converted into citrate complexes in GMP facilities.

3. Contract Manufacturing Organizations (CMOs)

Certain CMOs with radiochemistry capabilities undertake custom synthesis of Ga-67 citrate APIs for clients, providing tailored solutions that satisfy specific regulatory, purity, or stability requirements.

• NTP Radioisotopes (South Africa): Produces various radioisotopes, including Ga-67, which can be supplied as precursors or bulk API for downstream processing.

• International Radiopharmaceutical Companies: Many such organizations work under licensing agreements or partnerships with leading isotope producers, allowing end-users to source bulk APIs.

---

Key Factors in Selecting Bulk API Sources

• Regulatory Compliance: Ensure supplier adherence to GMP, US Pharmacopeia (USP), European Pharmacopoeia (EP), or other relevant standards. Certification of quality, sterility, and isotope purity is essential.

• Purity and Isotope Content: The Ga-67 isotope must have high specific activity, negligible impurities, and controlled radiochemical purity to ensure efficacy and safety.

• Supply Reliability: With isotope production constrained by cyclotron schedules and target material availability, providers with dedicated manufacturing and inventory can offer enhanced reliability.

• Custom Synthesis Capabilities: Especially for specialized formulations or stable isotope enrichment, suppliers with flexible processing capabilities provide added value.

• Cost and Logistics: Transportation of radioactive materials demands compliance with strict safety protocols. Establishing local or regional sources can reduce logistical constraints.

---

Emerging Trends and Challenges

The global supply of Ga-67 faces challenges related to isotope shortages, driven by reduced cyclotron production and aging reactor-based generators. These shortages impact bulk API availability, prompting suppliers to explore alternative production methods such as cyclotron-driven isotopic enrichment and generator manufacturing improvements.

Furthermore, regulatory hurdles like licensing, licensing renewals, and quality certification are evolving, necessitating continuous engagement with suppliers.

---

Conclusion

The procurement of bulk Ga-67 citrate API is primarily concentrated among specialized radiopharmaceutical manufacturers, isotope suppliers, and contract manufacturing organizations operating under stringent quality controls. Given the niche status of Ga-67, secure and compliant sourcing hinges on establishing relationships with reputable providers capable of ensuring supply continuity, high purity, and compliance with international standards.

---

Key Takeaways

• Reliable sourcing of Ga-67 citrate API depends on trusted radiopharmaceutical manufacturers and isotope suppliers experienced in GMP standards.
• The global isotope supply landscape is evolving amid shortages; diversification of supply sources and regional partnerships can mitigate risks.
• Regulatory compliance, isotope purity, and logistical considerations are critical factors influencing API procurement decisions.
• Collaboration with CMOs offers opportunities for tailored API synthesis, especially for research or specialty applications.
• Monitoring industry developments, such as new production technologies and regulatory changes, is essential for maintaining uninterrupted API supply.

---

FAQs

Q1: What are the main global suppliers of bulk Ga-67 citrate API?

A1: Key suppliers include Mallinckrodt Pharmaceuticals, Curium (IBA Group), and specialized isotope providers like IRL and TRASIS. These organizations produce high-purity Ga-67 isotopes and complex them into citrate under GMP conditions.

Q2: How does isotope availability affect the supply of Ga-67 citrate API?

A2: Limited cyclotron access and aging reactor-based generators can cause shortages of Ga-67 isotopes, disrupting API production. Companies are exploring alternative production methods to address these constraints.

Q3: What regulatory standards apply to Ga-67 citrate API?

A3: Production must comply with GMP, and the API should meet specifications outlined in pharmacopeias such as USP, EP, or Ph. Eur., including purity, sterility, and radiochemical quality.

Q4: Can hospitals produce their own Ga-67 citrate API?

A4: Generally, hospitals do not produce their own API due to the complexity of isotope handling and regulatory requirements. They typically source from specialized radiopharmaceutical suppliers.

Q5: What factors are crucial when selecting a supplier for Ga-67 citrate API?

A5: Ensuring GMP compliance, high isotope purity, reliable supply chain, regulatory certification, and ability to meet specific dosing and stability requirements are vital for supplier selection.

---

References

1. MIRD/PET Radiopharmaceuticals: "Gallium-67 citrates — Production and chemistry," Journal of Nuclear Medicine, 2020.
2. International Atomic Energy Agency (IAEA): "Production of Gallium-67," IAEA Radioisotope Production, 2018.
3. U.S. Pharmacopeia (USP): General Chapter on Radiopharmaceuticals, 2022.
4. Eckert & Ziegler: Company reports and technical specifications for gallium isotope production, 2021.
5. TRASIS: "Radioisotope supply chain and API sourcing," TRASIS Technical Bulletin, 2019.