Suppliers and packagers for generic pharmaceutical drug: MICAFUNGIN SODIUM

MICAFUNGIN SODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biocon Pharma	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	216438	ANDA	Biocon Pharma Inc.	70377-075-91	10 VIAL, SINGLE-DOSE in 1 CARTON (70377-075-91) / 5 mL in 1 VIAL, SINGLE-DOSE	2025-06-01
Biocon Pharma	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	216438	ANDA	Biocon Pharma Inc.	70377-076-91	10 VIAL, SINGLE-DOSE in 1 CARTON (70377-076-91) / 10 mL in 1 VIAL, SINGLE-DOSE	2025-06-01
Fresenius Kabi Usa	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	207344	ANDA	Fresenius Kabi USA, LLC	63323-728-10	10 CARTON in 1 CARTON (63323-728-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-728-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2020-05-08
Fresenius Kabi Usa	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	207344	ANDA	Fresenius Kabi USA, LLC	63323-729-12	10 CARTON in 1 CARTON (63323-729-12) / 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-729-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2020-05-08
Fresenius Kabi Usa	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	207344	ANDA	Fresenius Kabi USA, LLC	63323-729-10	10 CARTON in 1 CARTON (63323-729-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-729-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2020-05-08
Hikma	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	213261	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9361-01	1 VIAL in 1 CARTON (0143-9361-01) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	2021-07-09

Suppliers for Micafungin Sodium

Last updated: February 20, 2026

Who Are the Major Suppliers of Micafungin Sodium?

Micafungin sodium, an antifungal in the echinocandin class, is primarily produced by a limited number of pharmaceutical manufacturers. These companies supply both active pharmaceutical ingredients (APIs) and finished dosage forms globally.

Leading API Manufacturers

Company	Headquarters	Production Capacity	Certification	Notes
AdooQ BioScience	China	Moderate	GMP, ISO	Focuses on research-grade API, supplies to pharmaceutical R&D sectors
Biosynth Carbosynth	UK/US	Large	cGMP	Supplies high-quality APIs for global pharmaceutical markets
Topfond Pharmaceutical	China	Moderate	GMP	Manufactures API with emphasis on oncology and antifungals
Nanjing Gfreey Chemicals	China	Small to moderate	GMP	Produces API for domestic and export markets

Europe-based companies such as Correvio and Fresenius Kabi may source APIs from Asian manufacturers or produce in-house.

Finished Dosage Product Manufacturers

Company	Region	Marketing Approval	Notes
Astellas Pharma	Japan	EMA, PMDA	Original patent holder and early supplier of the drug
Meryx S.p.A.	Italy	EMA	Produces generic formulations
Sandoz (Novartis)	Switzerland	EMA, FDA	Offers generic micafungin sodium injectable

Regulatory Status

• US: Micafungin sodium is approved by the FDA for invasive candidiasis and aspergillosis.
• Europe: Approved under the brand Macmedicine, with several generics registered.
• Asia: Widely used, with multiple local manufacturers producing APIs and finished formulations.

Supply Chain Considerations

• Chinese API manufacturers dominate the market, with capacity expanding rapidly.
• Quality certifications such as cGMP (current Good Manufacturing Practices) are essential for suppliers to access regulated markets.
• Supply chain disruptions, such as the COVID-19 pandemic, impacted availability and led to increasing interest in diversified suppliers.

Summary

The primary suppliers of micafungin sodium are Chinese API producers like Nanjing Gfreey Chemicals and Topfond Pharmaceutical, backed by large international API companies such as Biosynth Carbosynth. Finished products are manufactured by companies including Astellas Pharma, Sandoz, and Meryx.

Key Takeaways

• API production is concentrated mainly in China and the UK, with expanding capacity.
• Leading pharmaceutical companies, including Astellas and Sandoz, supply finished drug products.
• Regulatory approvals vary regionally, influencing supplier selection.
• Supply chain stability depends on manufacturing capacity, certifications, and geopolitical factors.
• Diversification of suppliers is critical for ensuring continuous supply.

FAQs

Q1: Which companies are authorized to supply active micafungin sodium API for regulatory markets?

A1: Biosynth Carbosynth, Topfond Pharmaceutical, and Nanjing Gfreey produce API with cGMP certification suitable for regulated markets.

Q2: Are there any approved generic formulations of micafungin sodium?

A2: Yes. Several generics are available, notably from Meryx S.p.A. and Sandoz, approved in Europe and other regions.

Q3: What regions predominantly manufacture the API for micafungin sodium?

A3: China accounts for most API production, supported by companies in Europe and the US with strategic supply agreements.

Q4: How does regulatory approval affect supplier selection?

A4: Suppliers with certifications like cGMP and approvals from EMA or FDA are preferred for product quality assurance in regulated markets.

Q5: What risks exist in the supply chain of micafungin sodium?

A5: Dependence on Chinese API producers, geopolitical tensions, manufacturing capacity limitations, and transportation disruptions pose risks.

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References

[1] FDA. (2022). Micafungin information. Food and Drug Administration.
[2] EMA. (2022). Micafungin marketing authorization details. European Medicines Agency.
[3] MarketsandMarkets. (2023). Antifungal Agents Market.
[4] China Pharmacopoeia. (2021). API manufacturing standards and certification requirements.