MIACALCIN: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Ireland Ltd	MIACALCIN	calcitonin salmon	INJECTABLE;INJECTION	017808	NDA	Mylan Institutional LLC	67457-675-02	1 VIAL, MULTI-DOSE in 1 CARTON (67457-675-02) / 2 mL in 1 VIAL, MULTI-DOSE	2016-09-16
Mylan Ireland Ltd	MIACALCIN	calcitonin salmon	INJECTABLE;INJECTION	017808	NDA	Mylan Institutional LLC	72078-038-02	1 VIAL, MULTI-DOSE in 1 CARTON (72078-038-02) / 2 mL in 1 VIAL, MULTI-DOSE	2022-06-16
Mylan Ireland Ltd	MIACALCIN	calcitonin salmon	INJECTABLE;INJECTION	017808	NDA	Mylan Institutional LLC	72078-039-02	1 VIAL, MULTI-DOSE in 1 CARTON (72078-039-02) / 2 mL in 1 VIAL, MULTI-DOSE	2022-07-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

MIACALCIN, a brand name for calcitonin, is a synthetic form of human calcitonin used predominantly in the management of conditions such as osteoporosis, Paget’s disease of bone, and hypercalcemia. As a peptide hormone, calcitonin plays a critical role in calcium homeostasis, and its pharmaceutical formulation is crucial in both the therapeutic landscape and the supply chain for healthcare providers. Identifying reliable suppliers of MIACALCIN is essential for manufacturers, healthcare institutions, and distributors aiming to ensure drug availability, compliance with regulatory standards, and cost efficiency.

This article provides a comprehensive overview of current suppliers for MIACALCIN, analyzing manufacturing sources, regional distribution, regulatory considerations, and market dynamics pertinent to procurement and strategic planning.

Manufacturers of MIACALCIN

Global Leaders and Manufacturing Bases

The production of MIACALCIN involves complex peptide synthesis processes, requiring high standards of purity and stability. Leading pharmaceutical companies and biotechnology firms globally manufacture calcitonin products, including MIACALCIN.

Novartis: Historically, Novartis has been a significant supplier of calcitonin products, including nasal sprays and injectable forms. The company’s manufacturing facilities in Europe and the United States have adhered to stringent GMP standards, enabling consistent supply of high-quality calcitonin formulations. Although Novartis withdrew certain calcitonin products from the market in recent years, their legacy products still influence the supplier landscape.
Teva Pharmaceuticals: A prominent generic manufacturer, Teva produces calcitonin formulations, including injectable forms similar to MIACALCIN. Their manufacturing facilities in Israel and the United States focus on peptide synthesis and sterile injectable production, making them key suppliers for hospitals and clinics.
Biological E.: A smaller biotech firm specializing in peptide therapeutics, Biological E. offers biosimilar calcitonin products and has facilities in India and regional distribution centers in Asia and Africa. Their competitive pricing and adherence to international GMP standards position them as an emerging supplier.
Yamanouchi (now part of Astellas Pharma): Japanese pharmaceutical company with legacy calcitonin products supplied regionally in Asia and the Pacific. Their production facilities meet global standards, contributing to regional supply chains.
Other Regional Manufacturers: Several regional entities in India, China, and Eastern Europe produce calcitonin formulations under licensing agreements or generic pathways. These include companies like Sun Pharma and Cipla, which manufacture peptide-based injectables meeting regulatory standards for domestic and some export markets.

Regional Distribution and Regulatory Considerations

North America

In the United States, the Food and Drug Administration (FDA) regulates calcitonin products, including MIACALCIN. Currently, the primary suppliers have historically included Novartis and Teva, although market withdrawal impacts availability. There exists an opportunity for biosimilar manufacturers to fill potential gaps, provided they meet FDA biologics licensing standards.

Europe

The European Medicines Agency (EMA) oversees calcitonin formulations. Multiple generic manufacturers supply calcitonin prefilled syringes and nasal sprays, with companies like Teva, Merck, and Innovator companies holding licenses. Regulatory approval processes emphasize biosimilarity, manufacturing quality, and patient safety.

Asia-Pacific

India and China host numerous regional suppliers, driven by large peptide synthesis capabilities and lower production costs. Regulatory frameworks vary, but companies like Sun Pharma and Cipla meet standards aligned with the Drug Controller General of India (DCGI). The regional demand for calcitonin is high due to emerging osteoporosis burdens.

Emerging Markets

Latin America and Africa see supplies primarily from regional biotech firms and importers. Regulatory pathways often involve alignment with local health authorities, with some reliance on imported products with WHO prequalification.

Supply Chain Challenges and Opportunities

Quality Assurance and Regulatory Compliance

Reliable suppliers comply with GMP, GLP, and other international standards. The complexity of peptide synthesis necessitates rigorous quality control measures—biologics and peptide-based drugs are sensitive to production variations, which can impact efficacy and safety.

Supply Chain Disruptions

Global manufacturing disruptions, especially during the COVID-19 pandemic, exposed vulnerabilities in peptide supply chains. Shortages of MIACALCIN can result from manufacturing delays, regulatory hurdles, or raw material shortages.

Biosimilar Development

The rise of biosimilar calcitonin products offers potential cost reductions and increased supply. Companies investing in biosimilar development seek regulatory approval for their versions of calcitonin, potentially broadening the supplier base for MIACALCIN.

Innovation and Future Trends

Advances in peptide synthesis, such as solid-phase peptide synthesis (SPPS), and recombinant DNA technology, are increasing production efficiency. These innovations could lead to more diverse suppliers and stable supply chains for MIACALCIN in the future.

Key Considerations for Procurement

Regulatory Verification: Ensure suppliers hold approved manufacturing licenses from relevant authorities (FDA, EMA, DCGI, etc.).
Quality Certifications: Prioritize suppliers with GMP certification and third-party audit verifications.
Supply Stability: Evaluate historical supply reliability and capacity for scale-up during global demand surges.
Cost and Pricing: Balance quality and price, especially when considering biosimilars and regional manufacturers.
Traceability and Documentation: Maintain detailed procurement documentation for regulatory compliance and batch recall management.

Conclusion

The supply landscape for MIACALCIN encompasses a variety of global manufacturers, regional biotech firms, and generic producers. While longstanding players like Novartis and Teva continue to be key suppliers, market dynamics—including biosimilar entry, regulatory developments, and manufacturing innovations—are diversifying the supplier base. Stakeholders must rigorously vet suppliers for compliance, quality, and reliability, especially in a context where peptide-based drugs entail complex manufacturing and storage requirements.

Ensuring a resilient supply chain for MIACALCIN necessitates continuous market monitoring, regulatory engagement, and strategic supplier diversification. The ongoing development of biosimilars and emerging manufacturing technologies represent pathways toward more stable, cost-effective access to calcitonin therapies.

Key Takeaways

The dominant suppliers for MIACALCIN historically include Novartis and Teva, with regional players emerging from India and China.
Manufacturing of calcitonin involves complex peptide synthesis, requiring stringent regulatory compliance and quality assurance.
Global supply chain disruptions highlight the need for diversified sourcing and robust supplier vetting.
Biosimilars are reshaping the market, presenting opportunities for increased supply and decreased costs.
Strategic procurement should focus on regulatory approval status, manufacturing quality, supply reliability, and cost-effectiveness.

FAQs

1. Are there biosimilar versions of MIACALCIN available on the market?
Yes, several biosimilar calcitonin products are in development or approved in various regions, which may serve as alternatives to traditional formulations like MIACALCIN. Their availability depends on regulatory approval and regional market conditions.

2. How can healthcare providers verify the quality of MIACALCIN suppliers?
Providers should verify GMP certification, regulatory approvals (FDA, EMA, etc.), batch testing reports, and vendor audits to ensure product safety and efficacy.

3. What factors influence the price of MIACALCIN from different suppliers?
Pricing is affected by production scale, raw material costs, manufacturing complexity, regulatory compliance, regional market conditions, and competitive landscape.

4. Are there supply risks associated with regional manufacturers of calcitonin?
Yes, regional manufacturers may face challenges such as regulatory hurdles, limited manufacturing capacity, or raw material shortages, which can affect supply stability.

5. How might advances in peptide synthesis technology impact the MIACALCIN supply chain?
Technological advances can lower production costs, improve quality, enable rapid scale-up, and diversify supplier options, thereby strengthening the overall supply chain resilience.

Sources:
[1] Regulatory agencies’ databases (FDA, EMA).
[2] Industry reports on peptide pharmaceuticals.
[3] Company disclosures and manufacturing statements.

Suppliers and packagers for MIACALCIN

MIACALCIN

Suppliers for the Pharmaceutical Drug: MIACALCIN