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Suppliers and packagers for reyataz
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reyataz
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-3622-12 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3622-12) | 2003-06-24 |
| Bristol Myers Squibb | REYATAZ | atazanavir sulfate | CAPSULE;ORAL | 021567 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-3631-12 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3631-12) | 2003-06-24 |
| Bristol Myers Squibb | REYATAZ | atazanavir sulfate | POWDER;ORAL | 206352 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-3638-10 | 30 PACKET in 1 CARTON (0003-3638-10) / 1 POWDER in 1 PACKET | 2014-12-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: REYATAZ
Introduction
Reyataz (generic name: atazanavir sulfate) is an antiretroviral medication developed for the treatment of HIV-1 infection. It belongs to the protease inhibitor class, pivotal in managing HIV/AIDS. The drug’s manufacturing and distribution involve multiple suppliers, including raw material providers, active pharmaceutical ingredient (API) producers, formulation manufacturers, and distributors. An understanding of these sourcing channels is vital for stakeholders, including healthcare providers, investors, and supply chain managers, to ensure drug availability, compliance, and competitive positioning.
Manufacturing and Supply Chain Overview
Reyataz is produced primarily through a complex, multi-tiered supply chain involving raw material procurement, API synthesis, formulation, packaging, and distribution. The key players span global pharmaceutical giants, chemical suppliers, and regional distributors, fostering diversification and risk mitigation. Notable companies involved at various stages are as follows.
Active Pharmaceutical Ingredient (API) Suppliers for Reyataz
1. Catalent Inc.
Catalent is a leading contract development and manufacturing organization (CDMO) specializing in pharmaceutical APIs and formulations. They have been involved in producing atazanavir API and its intermediates under strict quality controls. Catalent's facilities are certified by global regulators such as the FDA and EMA, ensuring compliance with Good Manufacturing Practice (GMP) standards.
2. Apotex Inc.
A prominent Canadian generic pharmaceutical company, Apotex manufactures APIs and finished dosage forms, including atazanavir. The company has multiple manufacturing sites in North America and Asia, providing a reliable supply chain for atazanavir API, especially for generic formulations.
3. Mylan (now part of Viatris)
Viatris, formed through Mylan and Pfizer's generic drug divisions merger, supplies atazanavir API, leveraging extensive manufacturing infrastructure across the U.S. and India. Their experience in high-volume API production supports global supply needs.
4. Sun Pharmaceutical Industries Ltd.
An Indian pharmaceutical major, Sun Pharma produces APIs including atazanavir, serving both domestic and international markets. Their integrated supply chain ensures cost-effective production aligned with global regulatory standards.
Formulation and Finished Product Manufacturers
1. Bristol-Myers Squibb
Originally developed and marketed Reyataz, Bristol-Myers Squibb (BMS) retains significant manufacturing capabilities for the finished product, either through in-house facilities or licensed manufacturing partners. They manage global distribution and supply logistics, ensuring product availability worldwide.
2. Teva Pharmaceutical Industries Ltd.
Teva, a leading generic manufacturer, has been known to produce affordable formulations of Reyataz, including co-packaging with other antiretrovirals for combination therapy. Their extensive global network guarantees broad access, especially in emerging markets.
3. Cipla Limited
An Indian pharmaceutical giant, Cipla produces generic atazanavir and fixed-dose combinations (FDCs), catering to populations with limited access to branded drugs. Their manufacturing complies with WHO GMP standards, ensuring quality for global distribution.
4. Mylan/Viatris
Viatris (formerly Mylan) also manufactures finished Reyataz formulations for various markets, leveraging a robust supply chain optimized for cost efficiency and geographic reach.
Key Raw Material Suppliers and Intermediates
1. Sabic Innovative Plastics
Supplying specialty chemicals utilized in API synthesis, Sabic provides unique intermediates necessary for atazanavir production, ensuring phase-specific chemical reactions and purity.
2. Bachem AG
Specializes in custom peptide synthesis and chemical intermediates. Bachem’s expertise supports API synthesis, ensuring high purity and compliance with regulatory standards.
3. Jiangsu Hengrui Medicine Co., Ltd.
A prominent Chinese API producer, Hengrui supplies intermediates and raw materials integral to atazanavir synthesis, often aligned with cost-effective large-scale production.
Distribution and Logistics
Global distribution involves licensed pharmaceutical distributors operating under strict regulatory guidelines to ensure cold chain management, expiry diligence, and compliance. Companies such as McKesson, Cardinal Health, and Alliance Healthcare distribute Reyataz to hospitals, pharmacies, and governments worldwide, maintaining consistent stock levels and minimizing shortages.
Emerging Suppliers & Strategic Considerations
- Regional Suppliers: Countries with burgeoning HIV treatment programs, such as India, South Africa, and Brazil, increasingly source APIs and formulations locally or regionally. Local manufacturing reduces costs and enhances supply resilience.
- Supply Chain Risks: Dependence on specific API producers, geopolitical factors, and regulatory hurdles can disrupt supply. Diversification across suppliers and regions helps mitigate risks.
Regulatory and Quality Assurance
Suppliers are typically audited and certified according to international standards, including ICH Q7 for APIs, ISO certifications, and GMP compliance. Suppliers with stringent quality control protocols are preferred, especially for products destined for high-income countries with rigorous regulatory requirements.
Market Dynamics and Future Outlook
The global demand for Reyataz is primarily driven by HIV/AIDS management programs, with notable growth in emerging markets. Patent expirations and the rise of generic competitors have increased supplier diversification, resulting in competitive pricing and broader access. Furthermore, ongoing efforts to improve supply chain transparency and traceability (e.g., track & trace systems, blockchain) are shaping how suppliers interact within this ecosystem.
Biopharmaceutical companies and generic producers are investing in sustainable sourcing and expanding manufacturing bases to meet increasing global demand, which is expected to sustain the supply chain’s resilience and capacity.
Key Takeaways
- The supply landscape for Reyataz comprises a mix of originator and generic manufacturers, including Bristol-Myers Squibb, Viatris, Cipla, and Teva.
- API production primarily occurs in North America, Europe, and Asia, with key suppliers like Apotex, Sun Pharma, and regional Chinese manufacturers.
- Finished formulations are distributed by major global logistics providers, adhering to strict quality and regulatory standards.
- Supply chain risks include geopolitical instability, raw material shortages, and regulatory changes; diversification remains crucial.
- Evolving markets, patent expirations, and strategic partnerships influence the supplier network substantially.
FAQs
1. Who are the primary API suppliers for Reyataz?
Leading API suppliers include Apotex, Sun Pharma, and Chinese manufacturers like Jiangsu Hengrui Medicine, supported by contract manufacturers such as Catalent.
2. Are generic versions of Reyataz available, and who supplies them?
Yes, generics are supplied by companies like Cipla, Teva, and Mylan (Viatris), offering more affordable options in markets worldwide.
3. How does supply chain complexity affect Reyataz availability?
Complex supply chains, with multiple tiers of raw material sourcing and manufacturing hubs, can introduce risks of shortages, especially during geopolitical or regulatory disruptions.
4. What are the quality standards maintained by Reyataz suppliers?
Suppliers adhere to international standards like GMP, ICH Q7, and ISO, with rigorous audits and certification to ensure product safety and efficacy.
5. How might future patent expirations impact Reyataz’s supply landscape?
Patent expirations generally increase generic competition, expanding supplier options, reducing prices, and improving access—though they may also increase supply chain complexity.
References
[1] U.S. Food and Drug Administration (FDA). “Approved Drugs: Reyataz (atazanavir sulfate).”
[2] Bristol-Myers Squibb. “Reyataz Product Information.”
[3] Mylan and Viatris corporate reports on product manufacturing and supply.
[4] Cipla Ltd. Annual report and product portfolio documentation.
[5] World Health Organization (WHO). “Prequalification of Medicines Programme.”
[6] Industry reports on API manufacturing and global supply chain dynamics.
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