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Suppliers and packagers for generic pharmaceutical drug: RIFABUTIN
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RIFABUTIN
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 |
| Novitium Pharma | RIFABUTIN | rifabutin | CAPSULE;ORAL | 215041 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-738-01 | 100 CAPSULE in 1 BOTTLE (10135-738-01) | 2022-05-01 |
| Novitium Pharma | RIFABUTIN | rifabutin | CAPSULE;ORAL | 215041 | ANDA | ANI Pharmaceuticals, Inc. | 70954-041-10 | 100 CAPSULE in 1 BOTTLE (70954-041-10) | 2021-12-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Rifabutin
Introduction
Rifabutin, a semi-synthetic derivative of rifamycin, is an antibiotic primarily used in treating mycobacterial infections, notably tuberculosis and Mycobacterium avium complex (MAC) disease. As an alternative to rifampin, rifabutin exhibits potent antimicrobial activity and has become essential in certain clinical scenarios, especially for immunocompromised patients, such as those with HIV/AIDS.
Securing reliable sources of rifabutin is critical for pharmaceutical companies, healthcare providers, and regulatory agencies. The complex manufacturing process, regulatory hurdles, and intellectual property landscapes influence the availability and sourcing of rifabutin. This article provides an extensive overview of the key suppliers, manufacturing landscape, and considerations for sourcing rifabutin.
Manufacturers and Suppliers of Rifabutin
Leading Pharmaceutical Manufacturers
The production of rifabutin is concentrated among a handful of pharmaceutical companies, owing to its complex synthesis, regulatory requirements, and patented formulations.
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Tianjin Tianyao Pharmaceutical Co., Ltd. (China)
Tianjin Tianyao has established itself as one of the primary suppliers of generic rifabutin. The company is involved in R&D, manufacturing, and distribution, serving markets across Asia, Africa, and parts of Latin America. They have achieved approvals from certain regulatory agencies for generic formulations. -
Lupin Limited (India)
Lupin is a prominent generic pharmaceutical manufacturer with a broad portfolio. The company produces rifabutin in various formulations, including capsules, and has a significant presence in emerging markets. Lupin’s manufacturing facilities are cGMP-compliant, ensuring quality standards. -
Sandoz (Novartis) (Switzerland/Global)
As a division of Novartis, Sandoz produces and supplies various antibiotics, including rifabutin under its generic brand portfolio. Their global manufacturing network supports widespread distribution in Europe, North America, and Asia. -
Richmond Pharmacology (UK)
While primarily a research organization, Richmond Pharmacology supplies rifabutin for clinical trials and research purposes, positioning itself as a key vendor for non-commercial uses. -
Other regional manufacturers such as Hunan Top Pharm Chemical Co., Ltd. (China), Zhejiang Huahai Pharmaceutical Co., Ltd., and Aurobindo Pharma (India) are involved in manufacturing generic rifabutin, albeit in variable quantities and market presence.
Regulatory Status and Market Availability
Most manufacturers operate within the scope of regional approvals. The drug’s approval status varies:
- United States: Rifabutin is FDA-approved, with specific generic versions available from Sandoz and other manufacturers.
- European Union: Approved under the European Medicines Agency (EMA), with generic versions marketed by several suppliers.
- Asian and African Markets: Multiple local manufacturers produce rifabutin, often under WHO prequalification or national regulatory approval.
Supply Chain and Market Dynamics
Regulatory Challenges
Manufacturing rifabutin requires compliance with stringent quality standards, including Good Manufacturing Practices (GMP). Due to its complex synthesis process, regulatory approvals may entail significant documentation and validation. Companies must navigate patent landscapes, though generic manufacturing typically occurs post-patent expiry or under compulsory licensing in certain jurisdictions.
Patent Landscape
Originally patented by GlaxoSmithKline, the patent for rifabutin expired in key markets around the late 2000s or early 2010s, enabling generics to enter the market. Patent exclusivity in some regions continues, influencing pricing and supply options.
Pricing and Market Demand
Global demand for rifabutin is driven by tuberculosis and MAC treatment protocols, especially in HIV co-infected populations. Limited manufacturing players and high regulatory barriers result in relatively stable but potentially high pricing. However, generic manufacturers have gradually increased supply, lowering costs over time.
Key Considerations for Sourcing Rifabutin
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Quality Assurance
Ensure suppliers comply with WHO prequalification, FDA approval, or EMA certification. Verify batch-to-batch consistency and stability data. -
Regulatory Filings
Confirm that suppliers hold necessary regulatory approvals for targeted market distribution. -
Supply Reliability
Engage with manufacturers possessing robust production capacities and global distribution channels. -
Pricing and Contracts
Negotiate terms considering market demand, procurement volume, and long-term supply commitments. -
Logistical Expertise
Address Cold Chain and storage requirements due to rifabutin's chemical stability profile.
Emerging Trends and Future Outlook
The ongoing fight against tuberculosis and opportunistic infections sustains demand for rifabutin. Advances in synthetic methods and scale-up manufacturing, especially in China and India, are likely to expand supply options. However, regulatory complexities and patent landscapes would continue to influence global availability.
Furthermore, organizations such as WHO are advocating for wider adoption of quality-assured generics to reduce costs and increase access in low-income regions, encouraging more manufacturers to enter the rifabutin supply chain.
Key Takeaways
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Limited but Diverse Supplier Base: Major companies manufacturing rifabutin include Tianjin Tianyao, Lupin, Sandoz, and regional generics producers, with supply aligned with regional regulatory approvals.
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Regulatory and Patent Factors: Patents have largely expired in many regions, enabling generic production, but regulatory compliance remains a barrier for some manufacturers.
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Quality and Reliability: Sourcing should prioritize suppliers with WHO prequalification or equivalent certifications to ensure drug safety and efficacy.
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Market Trends: Increased manufacturing capacity in emerging markets coupled with global health initiatives suggest broader availability and reduced costs in the coming years.
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Strategic Sourcing: Industry stakeholders should establish long-term supply agreements and monitor regulatory developments to maintain product continuity.
FAQs
1. Is rifabutin available as a generic drug worldwide?
Yes, numerous generic manufacturers produce rifabutin, particularly in India and China. However, availability depends on regional regulatory approvals and patent status.
2. What factors influence the choice of a rifabutin supplier?
Quality assurance standards, regulatory approvals, manufacturing capacity, cost, and supply reliability are critical in selecting a supplier for rifabutin.
3. Are there concerns regarding the quality of rifabutin from emerging market manufacturers?
While many emerging market manufacturers comply with GMP standards and hold international certifications, due diligence including audits and documentation review is essential.
4. How does patent status affect rifabutin supply?
Patent expirations in many regions have allowed generic manufacturing, increasing supply options. In patent-protected markets, only licensed or branded versions are available.
5. What are the future prospects for rifabutin supply?
Growing global demand, especially in tuberculosis management, along with increased manufacturing capacity, is likely to enhance supply and reduce prices, improving access in resource-limited settings.
References
- World Health Organization. (2014). Consolidated Guidelines on Drug Resistance Mutations in Mycobacteria.
- U.S. Food and Drug Administration. Rifabutin Monograph.
- European Medicines Agency. Product information on rifabutin.
- Industry reports on global generic pharmaceutical manufacturing landscape.
- Patent and regulatory filings in key markets (publicly accessible).
This comprehensive review serves as an essential resource for pharmaceutical companies, procurement agencies, and healthcare providers aiming to understand the current landscape of rifabutin suppliers.
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