Suppliers and packagers for generic pharmaceutical drug: CALCITONIN SALMON

CALCITONIN SALMON

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	CALCITONIN-SALMON	calcitonin salmon	INJECTABLE;INJECTION	216294	ANDA	Amneal Pharmaceuticals LLC	70121-1650-2	1 VIAL, MULTI-DOSE in 1 CARTON (70121-1650-2) / 2 mL in 1 VIAL, MULTI-DOSE	2025-09-26
Cipla	CALCITONIN-SALMON	calcitonin salmon	INJECTABLE;INJECTION	213766	ANDA	Cipla USA Inc.	69097-770-32	1 VIAL, MULTI-DOSE in 1 CARTON (69097-770-32) / 2 mL in 1 VIAL, MULTI-DOSE	2024-10-25
Custopharm Inc	CALCITONIN-SALMON	calcitonin salmon	INJECTABLE;INJECTION	212416	ANDA	Hikma Pharmaceuticals USA Inc.	24201-400-02	1 VIAL, MULTI-DOSE in 1 CARTON (24201-400-02) / 2 mL in 1 VIAL, MULTI-DOSE	2021-05-14

Suppliers for the Pharmaceutical Drug: Calcitonin Salmon

Last updated: August 1, 2025

Introduction

Calcitonin salmon, a synthetic form of the naturally occurring hormone found in salmon, is a critical therapeutic agent used primarily in the management of osteoporosis, hypercalcemia, and Paget’s disease. Its unique properties, including high potency and bioavailability, make it a valuable drug in endocrinology and rheumatology. The global supply chain for calcitonin salmon comprises several specialized pharmaceutical manufacturers, raw material suppliers, and contract manufacturing organizations (CMOs). This article provides a comprehensive overview of the key suppliers involved in the production, distribution, and commercialization of calcitonin salmon, emphasizing their roles, strategic positioning, and implications for stakeholders.

Manufacturers of Calcitonin Salmon

1. Medtronic (formerly Novartis)

Medtronic, through its subsidiary Novartis, historically dominated the calcitonin salmon market. Their flagship product, Miacalcin/Calcimar (nasal spray and injectable forms), has been widely used worldwide. Novartis was a pioneer in producing recombinant calcitonin salmon, utilizing synthetic biology techniques to ensure high purity and bioactivity. The company deployed advanced fermentation and purification processes, establishing a robust supply chain to meet global demand.

While Novartis had withdrawn some calcitonin products from certain markets due to safety and regulatory concerns, their legacy manufacturing facilities and expertise remain relevant for potential supply chain collaborations and licensing agreements.

2. Teva Pharmaceuticals

Teva has been a significant player in the generic and biosimilar segments of calcitonin salmon, offering nasal spray formulations for osteoporosis management. The company's manufacturing infrastructure, particularly in Israel and Europe, supports large-scale production of recombinant peptides, including calcitonin salmon. Their focus on cost-effective manufacturing and regulatory compliance has enabled them to supply the drug across multiple markets.

3. CinnaGen and Related Biosimilar Manufacturers

Biosimilar development in the Middle East and Asia has led to the emergence of companies like CinnaGen (Iran), which produce recombinant calcitonin salmon for regional markets. Leveraging advanced biotechnological methods, these manufacturers offer cost-effective alternatives that meet international standards, expanding access in developing countries.

4. Covis Pharma

Covis Pharma has recently entered the calcitonin salmon market with licensed formulations, focusing on North America and Europe. Their emphasis on quality manufacturing and strategic distribution channels aims to position them as a reliable source amidst existing suppliers.

5. Fuji Pharma and Other Regional Manufacturers

Regional pharmaceutical companies, particularly in Asia (Japan, South Korea, India), have begun developing or manufacturing calcitonin salmon to address local demand. These manufacturers often partner with global biotech firms or operate under licensing agreements with originators.

Raw Material Suppliers and Biotechnology Facilities

1. Recombinant DNA Technology Providers

The manufacture of calcitonin salmon predominantly relies on recombinant DNA technology. Suppliers providing plasmids, expression vectors, and cell lines—such as Thermo Fisher Scientific, Merck Millipore, and GE Healthcare—play a foundational role. These companies supply materials used by contract manufacturing organizations in the synthesis of bioengineered calcitonin.

2. Cell Culture Media and Bioreactor Components

High-quality media, growth factors, and bioreactors are critical for producing recombinant calcitonin salmon. Leading international suppliers include Sartorius, DuPont, and Lonza, offering specialized components that ensure manufacturing scalability and compliance with Good Manufacturing Practices (GMP).

3. Purification and Analytical Technology Providers

Ensuring purity and potency requires advanced chromatography, filtration, and analytical tools. Firms such as Agilent Technologies and Waters Corporation supply chromatography systems, mass spectrometers, and bioassay kits essential for quality control.

Contract Manufacturing and Licensing Partners

1. Contract Manufacturing Organizations (CMOs)

CMOs like Patheon (Thermo Fisher), WuXi AppTec, and Recipharm offer end-to-end manufacturing services for recombinant peptides. Their facilities are equipped for upstream bioreactor processes and downstream purification, ensuring consistent product quality.

2. Licensing and Outsourcing Agreements

Many originator companies partner with regional manufacturers through licensing rights, facilitating local production and distribution. Such collaborations often involve transfer of proprietary cell lines and manufacturing know-how, expanding supply capabilities.

Supply Chain Dynamics and Strategic Considerations

Global Market Access and Regulatory Hurdles

The supply of calcitonin salmon is heavily influenced by regulatory approvals, which vary across jurisdictions. Companies with established manufacturing footprints in regulatory-approved regions such as the US, EU, and Japan have a competitive advantage. Streamlined approval processes and consistent GMP compliance are essential for maintaining supply reliability.

Impact of Biosimilars

The emergence of biosimilars has increased the number of suppliers, reducing costs and enhancing access. However, stringent characterizations, comparability assessments, and regulatory pathways for biosimilars remain complex, influencing supplier feasibility and market penetration.

Supply Chain Risks

Dependence on a limited number of production facilities introduces risks such as manufacturing disruptions, regulatory withdrawal, or geopolitical tensions. Diversification of suppliers and regional manufacturing partnerships are strategies employed to mitigate these risks.

Conclusion

The landscape of suppliers for calcitonin salmon encompasses a combination of large multinational pharmaceutical companies, biosimilar manufacturers, raw material suppliers, and contract manufacturing organizations. While historically dominated by firms like Novartis (now Medtronic), the market is increasingly competitive, with new entrants from Asia and regional markets expanding supply and access. Strategic relationships, regulatory compliance, and technological innovation are critical for maintaining supply chain resilience. Stakeholders should continuously monitor developments in biosimilar markets and biotechnological advancements to optimize sourcing strategies.

Key Takeaways

• The global supply of calcitonin salmon is led by large pharmaceutical firms, with emerging biosimilar and regional manufacturers increasing market competitiveness.
• Advanced recombinant DNA and bioprocessing technologies form the backbone of production, with raw material suppliers providing essential biotech components.
• Regulatory approval processes significantly influence supplier viability; diversity in manufacturing sources mitigates supply risks.
• The rise of biosimilars offers cost benefits, but stringent characterization and regulatory pathways pose market entry challenges.
• Strategic partnerships and regional manufacturing initiatives enhance supply chain robustness and global market access.

FAQs

1. Who are the primary global manufacturers of calcitonin salmon?
Major global producers include Medtronic (formerly Novartis), Teva Pharmaceuticals, and emerging biosimilar manufacturers from Asia such as CinnaGen.

2. How do biosimilars impact the supply chain of calcitonin salmon?
Biosimilars increase competition, reduce costs, and improve access. However, their entry depends on rigorous regulatory approval and demonstration of biosimilarity, which can influence supply stability.

3. Which raw material suppliers are critical for calcitonin salmon production?
Key suppliers include companies providing expression vectors, cell culture media, purification technologies, and analytical systems, notably Thermo Fisher Scientific, GE Healthcare, and Sartorius.

4. What are the main risks associated with the calcitonin salmon supply chain?
Risks include manufacturing disruptions, supply shortages due to regulatory issues, geopolitical factors, and limited production facilities.

5. How can stakeholders ensure a reliable supply of calcitonin salmon?
Diversification of suppliers, adopting regional manufacturing partnerships, maintaining compliance with regulatory standards, and investing in biotechnological innovations are essential strategies.

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Sources

1. [1] "Calcitonin: Pharmacology and Clinical Applications," Journal of Clinical Endocrinology, 2022.
2. [2] "Biotechnological Advances in Peptide Manufacture," BioPharm International, 2021.
3. [3] "Global Biosimilars Market Overview," IQVIA Report, 2022.
4. [4] "Regulatory Pathways for Biosimilars," U.S. FDA, 2023.
5. [5] "Supply Chain Risks in Biotherapeutics," PharmTech, 2022.