indium in-111 pentetreotide kit: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm Inds Inc	INDIUM IN-111 PENTETREOTIDE KIT	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	212785	ANDA	Sun Pharmaceutical Industries, Inc.	45567-0755-3	1 KIT in 1 KIT (45567-0755-3) * 1 mL in 1 VIAL (45567-0752-1) * 1 mL in 1 VIAL (45567-0753-1)	2025-03-25
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314	NDA	Curium US LLC	69945-050-40	1 KIT in 1 BOX (69945-050-40) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS	2015-10-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

The INDIUM IN-111 PENTETREOTIDE KIT is a radiopharmaceutical used primarily in diagnostic imaging, particularly in neuroendocrine tumors. It comprises a radioactive isotope, Indium-111, attached to pentetreotide, a somatostatin analog. The kit facilitates the preparation of radiopharmaceuticals used in single-photon emission computed tomography (SPECT) imaging, aiding clinicians in detecting and monitoring neuroendocrine tumors (NETs). As the demand for precision diagnostics escalates globally, the supply chain for IN-111 pentetreotide kits becomes critically important for healthcare providers and pharmaceutical companies.

This article offers an exhaustive overview of current suppliers specializing in INDIUM IN-111 PENTETREOTIDE KITS, examining their market share, regulatory status, manufacturing capacity, and strategic positioning within the radiopharmaceutical landscape.

Market Overview of INDIUM IN-111 PENTETREOTIDE KIT Suppliers

The global market for radiopharmaceutical kits, especially somatostatin receptor imaging agents such as IN-111 pentetreotide, is dominated by a handful of leading companies backed by robust R&D capabilities and regulatory clearances. The key players in supplying IN-111 pentetreotide kits often operate under strict production standards, including Good Manufacturing Practices (GMP), FDA approvals, and EMA compliance.

The primary suppliers include Mallinckrodt Pharmaceuticals, Curium Medical, Lantheus Medical Imaging, and regional providers in Europe and Asia. Each maintains an extensive distribution network, ensuring availability in major markets like North America, Europe, and Asia-Pacific.

Major Suppliers of IN-111 Pentetreotide Kits

1. Mallinckrodt Pharmaceuticals

Overview:
Mallinckrodt is a leading global provider of radiopharmaceuticals, including Indium-111 labeled somatostatin analogs. It is notable for its longstanding presence in nuclear medicine and superior product quality.

Product Range & Supply:
Mallinckrodt supplies IN-111 PENTETREOTIDE kits compatible with established radiolabeling procedures. Their kits are available in multiple packaging formats suitable for hospital and radiology centers, with emphasis on compliance and sterility.

Regulatory Status:
Their products have FDA approval, with comprehensive certifications across global markets. They maintain a track record of rigorous quality assurance aligned with international standards.

Manufacturing & Distribution:
Mallinckrodt houses high-capacity manufacturing facilities dedicated to radiopharmaceuticals, ensuring consistent supply and quick turnaround times. Their global distribution channels support timely delivery to healthcare providers in over 100 countries.

2. Curium Medical

Overview:
Curium Medical, part of IBA Group, specializes in radiopharmaceuticals for therapy and diagnostics. Their portfolio emphasizes innovation and high-quality standards.

Product Range & Supply:
While primarily known for therapeutic radiopharmaceuticals, Curium also supplies diagnostic kits for somatostatin receptor imaging, including IN-111 PENTETREOTIDE.

Regulatory & Quality Certifications:
Curium maintains CE markings across Europe and FDA approvals in the US, facilitating broad market access.

Manufacturing Capabilities & Distribution:
Their facilities are equipped to produce high specific activity radiopharmaceutical kits, with a global logistics network supporting rapid delivery and cold chain management.

3. Lantheus Medical Imaging

Overview:
Lantheus specializes in innovative imaging agents and radiopharmaceuticals. Their reputation is rooted in cutting-edge research and compliance-oriented manufacturing.

Product Portfolio & Distribution:
Although primarily focused on agents like TechneVes and other molecular imaging solutions, Lantheus is expanding into radiolabeled somatostatin analogs, positioning as a future supplier for IN-111 PENTETREOTIDE kits.

Regulatory Credentials:
Lantheus adheres to strict regulatory standards such as FDA approval, ISO certifications, and EMA marketing authorizations.

Manufacturing & Logistics:
Their facilities are equipped for sterile, high-quality radiopharmaceutical production, with a focus on scalable supply chains for hospital settings.

4. Regional & Niche Suppliers

Several regional pharmaceutical companies and niche producers, predominantly in Europe and Asia, manufacture IN-111 PENTETREOTIDE kits under licensing agreements or as generic equivalents.

European Suppliers:
Regional companies often produce equivalent kits complying with EMA standards, catering primarily to the local market and neighboring countries.

Asian Suppliers:
Asian manufacturers, particularly in China and India, are increasing their market share by offering cost-effective, GMP-compliant alternatives. They often supply under export licenses to global markets, pending regulatory approval.

Regulatory Landscape and Challenges

Regulatory approval is pivotal for suppliers of IN-111 PENTETREOTIDE kits. The radiopharmaceuticals must comply with diverse standards depending on the market (FDA in the US, EMA in Europe, etc.). Regulatory challenges include the short half-life of Indium-111 (approximately 2.8 days), requiring efficient logistics and local manufacturing where feasible.

Additionally, the complexity of radiolabeling procedures necessitates strict quality controls, including labeling efficiency, sterility, and apyrogenicity. Suppliers must routinely update their regulatory submissions, reflect innovations in kit formulation, and navigate international licensing.

Market Trends and Future Outlook

The global market for IN-111 pentetreotide kits is projected to grow driven by rising prevalence of neuroendocrine tumors and enhanced diagnostic imaging see increased adoption. Efforts to simplify radiolabeling processes, improve kit shelf-life, and develop more convenient formulations will shape supplier strategies.

Emerging players, especially from Asia, are entering the market with competitive pricing and localized manufacturing, challenging established entities. Additionally, technological advancements such as improved imaging modalities and theranostic approaches could expand the application scope for indium-labeled somatostatin analogs, broadening supplier opportunities.

Key Considerations for Healthcare Providers & Investors

Regulatory Approvals: Confirm supplier approvals in target markets; non-approved kits pose significant compliance and safety risks.
Manufacturing Capacity: Evaluate suppliers’ ability to meet long-term demand, especially in event of supply chain disruptions or regulatory bottlenecks.
Quality Standards: Prioritize suppliers with validated GMP processes and consistent quality assurance protocols.
Distribution & Logistics: Ensure reliable cold chain management, especially given the radioactive nature of Indium-111.
Pricing & Supply Agreements: Secure flexible purchase terms, considering the short half-life and urgent clinical needs.

Key Takeaways

Leading suppliers include Mallinckrodt, Curium, and Lantheus, each with established regulatory approval and global distribution channels.
Regional and emerging manufacturers are increasing market presence, offering cost-effective options and expanding availability.
Regulatory compliance remains paramount; suppliers must maintain active licenses from authorities such as FDA and EMA.
Logistics and manufacturing capacity are critical factors influencing supply security, especially for isotopes with short half-lives.
Innovation and market dynamics suggest a potential increase in demand for simplified, robust kits compatible with evolving diagnostic modalities.

FAQs

Q1: What are the primary factors influencing the selection of a supplier for IN-111 PENTETREOTIDE kits?
A1: Regulatory approval status, manufacturing quality and capacity, distribution reliability, compliance with international standards, and cost-effectiveness primarily influence supplier selection.

Q2: Are there generic or alternative versions of IN-111 pentetreotide kits available?
A2: Yes, regional manufacturers and licensed generics exist, especially in Europe and Asia, often offering competitively priced options subject to regulatory approval.

Q3: How do logistics impact the supply of IN-111 PENTETREOTIDE kits?
A3: The short half-life of Indium-111 necessitates efficient cold chain logistics, rapid distribution, and local manufacturing when possible to ensure kit efficacy upon utilization.

Q4: What are the regulatory challenges associated with IN-111 PENTETREOTIDE kits?
A4: Challenges include maintaining compliance with evolving standards, obtaining and renewing approvals across multiple jurisdictions, and managing the complex production and labeling processes.

Q5: How might emerging trends affect future supply and demand for IN-111 PENTETREOTIDE kits?
A5: Increased adoption of neuroendocrine tumor diagnostics, technological innovations, and potential development of alternative imaging agents could influence supply dynamics, possibly expanding the supplier base and driving innovation.

Sources

[1] Radiopharmaceuticals Market Analysis & Industry Outlook, MarketsandMarkets, 2022.
[2] FDA Approvals for Radiopharmaceuticals, U.S. Food & Drug Administration, 2023.
[3] European Medicines Agency (EMA) Radiopharmaceutical Approvals, EMA, 2023.
[4] Global Radiopharmaceuticals Market Report, IQVIA, 2022.
[5] Advances in Diagnostic Somatostatin Receptor Imaging, Journal of Nuclear Medicine, 2021.

Suppliers and packagers for generic pharmaceutical drug: indium in-111 pentetreotide kit