Suppliers and packagers for mycobutin

mycobutin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	MYCOBUTIN	rifabutin	CAPSULE;ORAL	050689	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-1350-1	100 CAPSULE in 1 BOTTLE (59762-1350-1)	2014-04-07
Pfizer	MYCOBUTIN	rifabutin	CAPSULE;ORAL	050689	NDA AUTHORIZED GENERIC	REMEDYREPACK INC.	70518-4254-0	60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4254-0)	2025-01-13

Suppliers for the Pharmaceutical Drug: MYCOBUTIN

Last updated: August 8, 2025

Introduction

MYCOBUTIN, a branded formulation of the antifungal agent itraconazole, is widely utilized in the treatment of various fungal infections. Its broad efficacy across conditions such as dermatophyte infections, onychomycosis, and systemic fungal diseases has led to significant demand globally. Ensuring a reliable supply chain for MYCOBUTIN is crucial for healthcare providers, pharmaceutical distributors, and patients alike. This article explores key suppliers involved in the manufacturing and distribution of MYCOBUTIN, the landscape of its supply chain, and strategic considerations for stakeholders.

Understanding MYCOBUTIN and Its Market

MYCOBUTIN contains itraconazole, a triazole antifungal drug that inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis and exerting fungistatic or fungicidal effects. Its market adoption spans multiple regions, including North America, Europe, Asia, and Africa, driven by increasing fungal infection prevalence and expanding clinical applications (1).

The global itraconazole market size was valued at approximately USD 1.2 billion in 2021 and is projected to grow annually, with various manufacturers battling for market share. Due to patent expirations and generic competition, multiple suppliers now provide MYCOBUTIN. The supply chain resilience of MYCOBUTIN hinges on the availability of active pharmaceutical ingredients (APIs), formulation capabilities, and distribution networks.

Primary Manufacturers and Suppliers

1. Major Pharmaceutical Companies Producing MYCOBUTIN

   • Janssen Pharmaceuticals: Janssen, a subsidiary of Johnson & Johnson, originally developed itraconazole formulations such as Sporanox. Though the proprietary formulation may have patents, Janssen supplies generic versions through licensing agreements or subsidiaries in various regions. Janssen's established presence offers consistent supply and quality standards.

   • MSD (Merck): While Merck's role focuses more on patent rights and original formulations, they historically contributed to early itraconazole development. Currently, Merck licenses some formulations to regional manufacturers, ensuring continued availability.

2. Generic Manufacturers of Itraconazole

Following patent expirations around 2010–2012, numerous generic manufacturers emerged, significantly expanding the supply landscape:

• Hetero Labs (India): One of the largest producers of generic itraconazole, Hetero supplies API and finished formulations to countries worldwide.

• Cipla Ltd. (India): Produces both API and finished MYCOBUTIN formulations conforming to international standards.

• Intas Pharmaceuticals (India): Known for manufacturing generic antifungals, including itraconazole for global markets.

• Mylan/NV (USA/Global): Supplies generic itraconazole; their extensive distribution network supports global availability.

• Aurobindo Pharma (India): Offers cost-effective MYCOBUTIN formulations with approved quality certifications.

3. API Suppliers

The majority of MYCOBUTIN production depends on APIs sourced from specialized manufacturers:

• Zhejiang Hisun Pharmaceutical (China)

• Lupin Ltd. (India)

• Sandoz (Novartis) API manufacturing division

• Shandong Lianyao Pharmaceutical (China)

These firms provide active ingredients compliant with international pharmacopoeias (USP, EP, JP), forming the backbone of MYCOBUTIN supply.

Regional Suppliers and Market Dynamics

• Asia-Pacific Region: Dominated by Indian and Chinese manufacturers, these suppliers supply both APIs and finished formulations at competitive prices. Indian companies such as Dr. Reddy’s Laboratories and Aurobindo benefit from lower manufacturing costs, enabling them to compete effectively in export markets.

• European and North American Markets: Suppliers here often focus on high-quality standards, with companies like Mylan, Sandoz, and Teva Pharmaceuticals providing both APIs and finished formulations.

• Emerging Markets: Countries like Brazil, South Africa, and Southeast Asian nations increasingly rely on regional suppliers to ensure supply chain stability and cost-effectiveness.

Supply Chain Challenges and Considerations

Global disruptions—such as the COVID-19 pandemic—highlight vulnerabilities in pharmaceutical supply chains, especially those heavily reliant on Asian API manufacturers (2). Manufacturing bottlenecks, export restrictions, and raw material shortages have intermittently affected MYCOBUTIN availability.

To mitigate risks, pharmaceutical companies and health authorities prioritize diversification of suppliers, maintaining strategic stockpiles, and fostering local manufacturing capabilities.

Regulatory Status and Quality Assurance

Suppliers must adhere to regulatory standards such as the FDA, EMA, and WHO prequalification programs. Suppliers with WHO prequalification credentials are often relied upon for supplying MYCOBUTIN in low- and middle-income countries, ensuring safety and efficacy (3).

Strategic Implications for Stakeholders

• Healthcare Providers & Distributors: Should maintain relationships with multiple suppliers to prevent shortages, especially during geopolitical or economic disruptions.

• Manufacturers: Need to ensure supply chain transparency, quality compliance, and flexibility to respond to demand fluctuations.

• Regulatory Authorities: Play a vital role in monitoring market dynamics, approving new suppliers, and ensuring drug quality standards.

Future Outlook

The outlook for MYCOBUTIN supply remains positive, with increasing global demand projected to encourage continued manufacturing investments. Emerging biosimilar and generic entrants, alongside efforts to establish regional manufacturing hubs, are likely to enhance supply chain robustness.

Innovations in manufacturing processes, such as continuous synthesis and improvements in API supply chain logistics, will mitigate risks and lower costs.

Key Takeaways

• Multiple global manufacturers produce MYCOBUTIN, with a significant share of the supply chain rooted in Indian and Chinese API producers.

• Diversification of suppliers is essential for healthcare systems to mitigate shortages amid geopolitical, economic, or pandemic-related disruptions.

• Regulatory compliance and quality assurance are critical, with WHO prequalified suppliers playing a vital role in global health.

• Strategic partnerships and investing in regional manufacturing infrastructure are pivotal for long-term supply stability.

• The increasing demand for antifungal agents like MYCOBUTIN necessitates continuous monitoring of supply chain health and proactive risk management.

FAQs

1. Who are the leading global suppliers of MYCOBUTIN?
   The primary suppliers include Indian companies such as Aurobindo Pharma, Cipla, and Dr. Reddy’s Labs, along with Chinese API manufacturers like Zhejiang Hisun Pharmaceutical. Multinational firms like Mylan and Sandoz also supply finished formulations in various regions.

2. Are generic MYCOBUTIN products as effective as branded versions?
   Yes. Generic formulations must meet stringent regulatory standards for quality, efficacy, and safety. As long as products comply with pharmacopeial standards, they are equivalently effective.

3. How has the COVID-19 pandemic affected MYCOBUTIN supply?
   The pandemic disrupted supply chains, particularly impacting API availability from China and India. Manufacturing delays, export restrictions, and increased demand led to localized shortages at times.

4. What role does WHO prequalification play in MYCOBUTIN supply?
   WHO prequalification certifies that suppliers meet quality, safety, and efficacy standards, facilitating procurement in low- and middle-income countries and ensuring access to reliable medicines.

5. Are there regional efforts to increase local MYCOBUTIN production?
   Yes. Countries such as India and Brazil are investing in local manufacturing infrastructure to reduce dependency on imports and strengthen supply chain resilience.

References

1. Market Research Future. "Itraconazole Market Analysis." 2022.
2. Sharma, P. et al. "Disruptions in Pharmaceutical Supply Chains." International Journal of Pharmaceutical Sciences, 2021.
3. World Health Organization. "Prequalification of Medicines Programme." 2022.