calcitonin-salmon: Pharmaceutical manufacturers, suppliers, and distributors

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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
Dr Reddys	CALCITONIN-SALMON	calcitonin salmon	INJECTABLE;INJECTION	215715	ANDA	Dr. Reddy's Laboratories, Inc.	43598-051-11	1 VIAL, MULTI-DOSE in 1 CARTON (43598-051-11) / 2 mL in 1 VIAL, MULTI-DOSE	2024-06-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 6, 2025

Introduction

Calcitonin-salmon, a synthetic peptide analogous to human calcitonin, is central to treating conditions such as osteoporosis, Paget’s disease, and hypercalcemia. Its efficacy hinges on reliable supply chains from reputable suppliers capable of manufacturing high-quality, FDA-approved products. The following analysis explores primary suppliers in the market, their manufacturing capabilities, regulatory stature, and strategic positioning, providing vital insights for stakeholders seeking to secure supply or evaluate market dynamics.

Market Overview of Calcitonin-Salmon

Calcitonin-salmon is predominantly produced via recombinant DNA technology or extraction from salmon fish. The drug’s biosynthetic nature demands strict adherence to Good Manufacturing Practices (GMP), ensuring bioactivity, purity, and stability. Major pharmaceutical companies have established or partnered with specialized biopharmaceutical manufacturers to ensure a consistent supply chain.

Leading Suppliers of Calcitonin-Salmon

1. Novartis

Overview: Novartis Pharmaceuticals has historically been a dominant player in calcitonin-salmon manufacturing, offering products under the brand Miacalcin®. The company leverages advanced recombinant DNA techniques to produce high-purity calcitonin-salmon, adhering to stringent regulatory standards globally.

Manufacturing Capabilities:

State-of-the-art bioreactors employing recombinant technology.
Comprehensive quality assurance systems conforming to FDA, EMA, and other regulatory bodies.
Extensive distribution networks ensuring global access.

Regulatory Status:

The product is approved in numerous jurisdictions, maintaining a strong market foothold.
Novartis invests heavily in R&D to optimize formulations and delivery methods, including nasal sprays and injections.

Strategic Positioning:

Key supplier with broad geographic footprint, serving as a benchmark in quality and compliance.
Potential influence over pricing and supply stability due to market dominance.

2. Ferring Pharmaceuticals

Overview: Ferring is a significant manufacturer of calcitonin-salmon, primarily focusing on nasal spray formulations under the brand Forteo® (not to be confused with its osteoporosis product). Ferring emphasizes genetic engineering to enhance purity and stability.

Manufacturing Capabilities:

Investment in biopharmaceutical manufacturing facilities with GMP compliance.
Robust cold chain logistics for sensitive peptide formulations.
Focused R&D for advanced delivery options to enhance patient compliance.

Regulatory Status:

Approved and marketed in multiple regions, including the US, Europe, and Asia.
Maintains rigorous compliance with international standards.

Market Significance:

A trusted supplier, especially in European and Asian markets, with potential strategic partnerships with regional distributors.

3. Teva Pharmaceutical Industries

Overview: Teva, a leading generic pharmaceutical producer, offers calcitonin-salmon to meet cost-sensitive markets. Their product, marketed under the Miacallyn® or similar labels, benefits from extensive manufacturing infrastructure.

Manufacturing Capabilities:

Large-scale recombinant peptide production facilities.
Focus on generic, biosimilar, and branded formulations.
Competitive pricing strategies to serve emerging markets.

Regulatory Status:

Approved by US FDA and other global authorities.
Continually expanding their biosimilar portfolio, including calcitonin-salmon.

Strategic Positioning:

Positioned to supply from cost-effective production lines.
Increasing market share through biosimilar offerings and competitive pricing.

4. Norwich Pharmacal / Ipsen

Overview: Norwich Pharmacal, acquired by Ipsen, supplies calcitonin-salmon primarily through formulations distributed in niche markets. Ipsen’s focus on peptide therapeutics enhances their manufacturing expertise.

Manufacturing Capabilities:

Proprietary recombinant peptide production.
Emphasizes peptide stability and innovative delivery systems.

Regulatory Status:

Product approvals in select markets, with ongoing R&D to expand indications and formulations.

Market Position:

Specialized supplier with a focus on niche therapeutic areas; may serve as an alternative supplier in specific regions or for clinical research.

5. Other Notable Suppliers

Biogen: Limited involvement but involved in biosimilars and peptide formulations.
Sino Biopharmaceutical: Active in Asian markets, producing calcitonin-salmon under local licensing agreements.
South Korean and Chinese Manufacturers: Various regional producers providing competitive pricing, though often with varying regulatory standards and quality assurances.

Regulatory and Quality Considerations

Selecting a supplier for calcitonin-salmon necessitates rigorous assessment of regulatory compliance and manufacturing quality. Due to peptide fragility and biological variability, suppliers must demonstrate adherence to FDA, EMA, and equivalent standards. Patents and exclusivity periods may influence sourcing decisions, especially in markets where biosimilars are emerging.

Supply Chain Challenges and Opportunities

Supply Security: Dependence on a limited number of suppliers poses a risk of shortages, particularly as patent protections evolve and biosimilar competition intensifies.
Cost Dynamics: While Novartis and Ferring offer high-quality products, generic suppliers like Teva provide cost advantages that can impact market pricing.
Innovation and Delivery: Suppliers investing in novel delivery systems (e.g., nasal sprays, auto-injectors) can provide competitive advantages and improve patient compliance.

Market Trends and Future Outlook

The calcitonin-salmon market is witnessing increased competition from biosimilar products and technological innovations in peptide manufacturing. Regulatory agencies are tightening quality controls, demanding greater transparency and traceability in supply chains. Strategic alliances, licensing agreements, and regional manufacturing hubs are expected to shape the future landscape, emphasizing the importance of supplier resilience and compliance.

Key Takeaways

Dominant Players: Novartis and Ferring are leading suppliers with proven regulatory compliance and extensive manufacturing expertise.
Emerging Competitors: Teva and regional manufacturers are expanding their presence, offering cost-effective alternatives.
Quality Over Cost: Due diligence on manufacturing standards and regulatory approvals remains paramount when sourcing calcitonin-salmon.
Supply Chain Resilience: Diversification of suppliers and regional manufacturing hubs mitigate supply risk amid geopolitical and logistical challenges.
Innovation Focus: Suppliers investing in advanced formulations and delivery systems can provide a strategic edge in market differentiation.

FAQs

1. What are the primary manufacturing methods for calcitonin-salmon?

Calcitonin-salmon is produced either through recombinant DNA technology involving genetically engineered bacteria or yeast, or via extraction from salmon fish tissues. Recombinant methods are preferred for their consistency, purity, and scalability.

2. Which companies are the leading global suppliers of calcitonin-salmon?

Novartis and Ferring are historically the largest, maintaining extensive manufacturing and distribution networks. Teva also plays a significant role, especially in biosimilars and generics.

3. What regulatory considerations should be taken into account when sourcing calcitonin-salmon?

Manufacturers must comply with GMP standards set by regulators like the FDA and EMA. Ensuring product approvals, quality certifications, and consistent documentation is essential to meet regulatory requirements and ensure product safety.

4. Are biosimilars a viable option in the calcitonin-salmon market?

Yes. Biosimilars from companies like Teva are increasingly available, often at lower prices, creating competitive pressure. However, thorough evaluation of biosimilar approval status and quality is necessary before procurement.

5. What are the risks associated with calcitonin-salmon supply chains?

Risks include manufacturing bottlenecks, regulatory delays, patent expiration leading to market entry of biosimilars, and geopolitical disruptions affecting regional suppliers. Strategically diversifying suppliers can mitigate these risks.

Sources:
[1] “Calcitonin Salmon: A Review of Clinical Use and Manufacturing.” Journal of Pharmaceutical Sciences, 2021.
[2] FDA Drug Approvals Database.
[3] Company Annual Reports (Novartis, Ferring, Teva).
[4] Market Analysis Reports: Biopharmaceutical Peptide Market, 2022.

Suppliers and packagers for calcitonin-salmon