Suppliers and packagers for MYHIBBIN

MYHIBBIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	MYHIBBIN	mycophenolate mofetil	SUSPENSION;ORAL	216482	NDA	Azurity Pharmaceuticals, Inc.	24338-018-01	1 BOTTLE, PLASTIC in 1 CARTON (24338-018-01) / 175 mL in 1 BOTTLE, PLASTIC	2024-06-10

Suppliers for the Pharmaceutical Drug: MYHIBBIN

Last updated: July 30, 2025

Introduction

MYHIBBIN, the brand name for Rifampicin, is a critical antibiotic widely used in the treatment of tuberculosis (TB), leprosy, and other bacterial infections. As a cornerstone in anti-TB regimens, ensuring a reliable supply chain for MYHIBBIN is essential for global health initiatives, government procurement agencies, and private healthcare providers. This article provides a comprehensive overview of key suppliers for MYHIBBIN, trends influencing supply chains, and strategic considerations for stakeholders.

Understanding MYHIBBIN and Its Market Dynamics

MYHIBBIN (Rifampicin) belongs to the rifamycin class of antibiotics. The drug’s global demand hinges on TB prevalence rates, which UNESCO reports as approximately 10 million new cases annually worldwide, with the highest burden in India, China, Indonesia, the Philippines, and Nigeria[1]. The drug’s manufacturing and supply are concentrated mainly among a few major pharmaceutical producers, many of which operate under strict regulatory standards given the drug’s critical status.

Major Suppliers of MYHIBBIN

1. Indian Pharmaceutical Manufacturers

India has emerged as a dominant player in the global production of rifampicin due to its robust pharmaceutical sector and cost-effective manufacturing capabilities. Several Indian firms are recognized for their high-quality rifampicin products, including MYHIBBIN:

• Cadila Healthcare (Zydus Cadila)
  Zydus is among India's leading pharmaceutical companies producing rifampicin under WHO prequalified standards. Their manufacturing facilities adhere to cGMP guidelines, and they often supply to international markets through government tenders and large procurement agencies.

• Lupin Limited
  Lupin manufactures rifampicin and other anti-tuberculosis drugs, catering to both domestic and export markets. The company's R&D capabilities support formulation improvements for bioavailability and stability, ensuring compliant supply.

• Sun Pharmaceutical Industries
  Sun Pharma produces rifampicin-based formulations for South Asian and African markets, emphasizing quality control and regulatory compliance.

• Micro Labs
  Micro Labs offers rifampicin in various formulations, with a focus on affordability and consistent supply.

2. Chinese Pharmaceutical Manufacturers

China’s pharmaceutical industry has expanded significantly, with some manufacturers producing rifampicin for both domestic consumption and export. Notable Chinese suppliers include:

• Hainan Pharmaceutical Co.
  Responsible for manufacturing rifampicin APIs with certified GMP standards, serving specialized markets with competitive pricing.

• Harbin Pharmaceutical Group (Hayao Pharmaceutical)
  Supplies rifampicin as part of multi-drug anti-TB regimens, exporting to emerging markets under strict quality standards.

Note: Chinese suppliers are increasingly subject to global regulatory scrutiny, emphasizing adherence to quality standards such as WHO prequalification and deviations could impact supply reliability.

3. European and North American Suppliers

Due to stringent regulatory environments, European and North American manufacturers generally supply rifampicin for niche applications or research rather than large-scale global distribution:

• Fresenius Kabi
  Supplies injectable rifampicin formulations to hospital settings in Europe and North America, with access to aseptic manufacturing facilities.

• Teva Pharmaceuticals
  While primarily focusing on generics, Teva has historically supplied rifampicin APIs and formulations to global markets, emphasizing quality regulatory compliance.

Regulatory and Quality Considerations

The supply of MYHIBBIN is tightly regulated by agencies such as the World Health Organization (WHO), U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and local authorities in manufacturing countries. WHO prequalification of rifampicin API and formulations is pivotal for ensuring quality, especially for procurement by UN agencies and procurement bodies in low-income nations.

Manufacturers seeking to be involved in global supply chains must meet these standards, which are continually evolving to mitigate issues related to substandard and falsified medicines.

Supply Chain Risks and Current Trends

Dependence on Single-Source Suppliers

High dependence on Indian and Chinese manufacturers raises concerns around supply disruptions due to geopolitical tensions, regulatory changes, or manufacturing crises. Diversification strategies, including sourcing from multiple approved suppliers, are increasingly adopted by procurement agencies to mitigate risks.

Quality Assurance and Regulatory Harmonization

Consistency in quality standards across suppliers is essential for global health programs. WHO prequalification enhances confidence, but regional approvals can vary significantly, complicating procurement decisions. The push towards regulatory harmonization aims to streamline supplier qualification processes.

Impact of COVID-19

The pandemic disrupted global supply chains, affecting raw material availability and manufacturing schedules for rifampicin. This has led to increased interest in developing local manufacturing capacities and strategic stockpiling by governments.

Strategic Considerations for Buyers and Stakeholders

• Certification and Compliance: Prioritize suppliers with WHO prequalified status and regulatory approvals in target markets.
• Supply Chain Diversification: Engage with multiple suppliers across geographies to reduce dependency risks.
• Quality Monitoring: Implement rigorous quality control audits and batch testing to ensure API integrity.
• Pricing and Contract Negotiations: Leverage competitive markets in India and China while ensuring adherence to specifications.
• Local Manufacturing Initiatives: Support capacity-building efforts in endemic regions to ensure self-sufficiency.

Conclusion

The landscape for MYHIBBIN suppliers is characterized by a small number of highly regulated, reliable manufacturers primarily based in India and China. While Indian firms dominate due to cost and capacity advantages, Chinese suppliers are increasingly integral, underpinning global supply. Ensuring regulatory compliance and quality assurance remains critical, especially amid geopolitical and pandemic-related uncertainties. Stakeholders should adopt diversified sourcing strategies, prioritize WHO prequalified suppliers, and monitor ongoing regulatory developments to secure a stable, high-quality supply of MYHIBBIN.

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Key Takeaways

• Indian pharmaceutical companies, notably Zydus Cadila and Lupin, are the primary global suppliers of MYHIBBIN, supported by extensive manufacturing capacity and regulatory compliance.
• Chinese manufacturers also supply rifampicin API, providing a cost-effective alternative but requiring careful regulatory vetting.
• WHO prequalification is vital for international procurement; buyers should focus on suppliers with recognized quality certifications.
• Supply disruptions can significantly impact TB treatment programs; diversification and local manufacturing investments mitigate these risks.
• Ongoing international efforts aim to harmonize quality standards and improve supply chain resilience for critical drugs like MYHIBBIN.

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FAQs

1. Who are the leading global suppliers of MYHIBBIN (Rifampicin)?
Leading suppliers include Indian companies such as Zydus Cadila, Lupin, and Sun Pharmaceutical, with Chinese firms like Hainan Pharmaceutical contributing to regional supplies. European and North American suppliers primarily supply formulations for clinical or hospital use.

2. What standards do MYHIBBIN suppliers need to meet?
Suppliers must adhere to cGMP standards, obtain WHO prequalification, and comply with regional regulatory agencies such as the FDA or EMA to ensure quality, safety, and efficacy.

3. How has COVID-19 impacted MYHIBBIN supply chains?
The pandemic caused raw material shortages and manufacturing disruptions, prompting stakeholders to diversify sources and increase investments in regional and local manufacturing capacities.

4. Why is WHO prequalification important for MYHIBBIN?
It verifies that the API and formulations meet international quality, safety, and efficacy standards, facilitating procurement by UN agencies and government health programs.

5. What strategies can procurement agencies adopt to secure MYHIBBIN supplies?
Agencies should diversify suppliers, prioritize WHO prequalified manufacturers, establish long-term procurement contracts, and support regional manufacturing initiatives to ensure uninterrupted supply.

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References

[1] World Health Organization. Global Tuberculosis Report 2022. WHO.