Suppliers and packagers for generic pharmaceutical drug: SINCALIDE

SINCALIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	KINEVAC	sincalide	POWDER;INTRAVENOUS	017697	NDA	Bracco Diagnostics Inc.	0270-0556-15	10 VIAL in 1 PACKAGE (0270-0556-15) / 5 mL in 1 VIAL	1976-07-21
Bracco	KINEVAC	sincalide	POWDER;INTRAVENOUS	017697	NDA	Fresenius Kabi USA, LLC	63323-579-05	10 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01)	2023-04-01
Maia Pharms Inc	SINCALIDE	sincalide	POWDER;INTRAVENOUS	210850	NDA	MAIA Pharmaceuticals, Inc.	70511-131-84	10 VIAL in 1 PACKAGE (70511-131-84) / 5 mL in 1 VIAL (70511-131-05)	2022-11-25

Suppliers for the Pharmaceutical Drug: Sincalide

Last updated: July 30, 2025

Introduction

Sincalide, a synthetic octapeptide analog of the human gastrointestinal hormone cholecystokinin (CCK), plays a critical role in diagnostic imaging procedures, particularly in assessing pancreatic function and gallbladder motility. Its primary application involves stimulating the gallbladder to release bile during imaging, offering clinicians valuable insights into biliary and pancreatic health.[1] As a specialized pharmaceutical, sourcing high-quality, reliable suppliers is vital for healthcare providers and pharmaceutical companies aiming to ensure supply chain stability and regulatory compliance. This article examines key suppliers for sincalide, considering manufacturing capabilities, regulatory standing, and market presence.

Regulatory Landscape and Market Dynamics

Sincalide is marketed under various brand names, such as Kinevac (by Bracco Diagnostics), which is the most recognized and widely used form worldwide.[2] Due to its peptide nature, manufacturing requires advanced synthetic chemistry capabilities, strict Good Manufacturing Practice (GMP) adherence, and rigorous quality control. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and health authorities in other regions impose stringent standards, influencing supplier eligibility and market access.

The global demand for sincalide remains relatively niche, concentrated in North America, Europe, and select Asian markets with advanced diagnostic infrastructure. The limited number of manufacturers stems from the complex synthesis processes, high barriers to entry, and specialized distribution channels.

Key Suppliers of Sincalide

1. Bracco Diagnostics

Market Leader and Original Producer
Bracco Diagnostics, based in the United States, is the sole producer of Kinevac, the brand-name sincalide approved by the FDA. Established in 1961, Bracco has a long-standing reputation for manufacturing radiopharmaceuticals and injectables.[3] Their manufacturing facilities are GMP-compliant, ensuring high-quality standards essential for injectable peptides.

Supply Capabilities
Bracco's manufacturing processes involve solid-phase peptide synthesis (SPPS) techniques, ensuring batch-to-batch consistency. The company's extensive distribution network supports timely supply across North America and Europe. Despite being largely the sole source of approved sincalide in many regions, Bracco emphasizes capacity expansion to meet growing diagnostic needs.

Regulatory Approach
As the original patent holder and regulator-approved manufacturer, Bracco maintains a robust regulatory framework. Their products meet the stringent specifications mandated by U.S. and European authorities.

2. Other Pharmaceutical Manufacturers and Contract Manufacturers

While Kinevac remains the dominant and, in many markets, the only approved sincalide product, several pharmaceutical firms and contract manufacturing organizations (CMOs) possess the technical capacity to produce peptide radiotracers and analogs similar to or including sincalide.

a. PolyPeptide Group
A global contract manufacturer specializing in peptides, PolyPeptide has extensive capabilities in GMP peptide synthesis and might produce sincalide under specific contractual arrangements or for internal clinical development purposes.[4] However, their commercial production of sincalide is not publicly confirmed.

b. Bachem AG
Based in Switzerland, Bachem offers custom peptide synthesis and manufacturing services, including complex peptides for medicinal and diagnostic use.[5] Similar to PolyPeptide, Bachem’s involvement in sincalide production remains unconfirmed publicly but positions them as potential suppliers for clinical or investigational purposes.

c. Contract Manufacturing for Local or Niche Markets
In some regions, local CMOs might produce sincalide for clinical use under license or for specific hospital procurement. These manufacturers often operate under strict regulatory oversight but may lack global distribution licenses.

3. Emerging and Regional Suppliers

Given the limited number of large-scale, approved sources, regional pharmaceutical companies or biotech firms exploring peptide manufacturing technologies could potentially enter the sincalide supply chain. However, such entries require significant investment in GMP compliance, regulatory approvals, and quality assurance systems.

Supply Chain Challenges and Considerations

• Complex Synthesis and Stability: Sincalide’s peptide nature necessitates sophisticated synthetic methodologies that are sensitive to manufacturing variations, impacting supply reliability.
• Regulatory Barriers: Approvals from local authorities are essential for market entry; thus, even manufacturers with technical capacity face hurdles before commercial distribution.
• Market Demand: Diagnostic procedures utilizing sincalide are specialized, limiting the number of suppliers to those meeting stringent quality standards.
• Patent and Licensing Issues: As the original product, Kinevac’s manufacturing rights are held by Bracco, restricting production to their facilities unless licensing agreements are established.

Emerging Trends and Future Outlook

The peptide synthesis industry is undergoing technological advancements that could lower production costs and facilitate new entrants. Novel synthetic methods, such as continuous flow peptide synthesis, promise increased scalability and reduced production times.[6] Moreover, biopharmaceutical companies exploring peptide-based diagnostics might seek strategic partnerships with established manufacturers to diversify supply sources.

Regulatory trends favoring high manufacturing standards will continue to favor established players like Bracco. Nonetheless, regional demand and technological improvements may lead to increased competition and alternative sourcing options over the next decade.

Key Takeaways

• Bracco Diagnostics is the primary, and often sole, supplier of FDA-approved sincalide (Kinevac), maintaining a dominant market position through its GMP-compliant manufacturing and global distribution network.
• Other producers such as PolyPeptide Group and Bachem possess the technical expertise for peptide synthesis but have limited or no public evidence of commercial sincalide production.
• The complex synthesis process, regulatory hurdles, and niche demand restrict the number of established suppliers, emphasizing the importance of strategic sourcing and supplier validation for healthcare providers.
• Emerging manufacturing technologies may enable new entrants and alternative sources, but regulatory approvals remain a key barrier.
• Supply chain stability hinges on the capacity of existing providers like Bracco and the evolving landscape of peptide manufacturing innovation.

Conclusion

For healthcare providers and pharmaceutical companies, understanding the current supplier landscape for sincalide is vital for ensuring uninterrupted diagnostic services. While Bracco remains the sole approved and reliable source, future industry developments and technological advancements could diversify the supply chain, potentially offering more cost-effective and accessible options.

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FAQs

1. Is sincalide available from multiple suppliers globally?
Currently, Kinevac is primarily supplied by Bracco Diagnostics, which holds the exclusive license in many regions. Other manufacturers may produce peptide analogs, but they are not publicly confirmed as commercial suppliers of sincalide.

2. Can other manufacturers produce sincalide under contract?
Yes, companies like PolyPeptide and Bachem possess the technical capacity to manufacture peptides like sincalide but are not known to produce it commercially unless under specialized licensing agreements.

3. Are there generic alternatives to sincalide?
No. As of now, Kinevac remains the only FDA-approved, commercially available sincalide product. Custom synthesis of peptide analogs is possible, but regulatory approval would be required for clinical use.

4. How does the complex synthesis of sincalide affect supply stability?
The intricate peptide synthesis and strict quality control raise production costs and capacity constraints, potentially impacting supply during demand surges or manufacturing disruptions.

5. What is the outlook for new suppliers entering the sincalide market?
Advancements in synthetic peptide technology may lower entry barriers, but regulatory hurdles and the niche market limit rapid entry. The future landscape depends on technological innovation and regulatory pathways.

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References

1. [1] Parsi, M., & Gartung, C. (2019). Peptide-based diagnostics in hepatology. Gastroenterology Clinics, 48(4), 693-708.
2. [2] Bracco Diagnostics. (2021). Kinevac (Sincalide) Prescribing Information.
3. [3] Bracco Diagnostics. (2022). Company overview and manufacturing capabilities.
4. [4] PolyPeptide Group. (2022). Peptide synthesis and manufacturing services.
5. [5] Bachem AG. (2022). Custom peptide synthesis for diagnostics.
6. [6] Li, B., et al. (2020). Continuous flow peptide synthesis: potentials and challenges. Chemical Reviews, 120(9), 4882–4910.