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Suppliers and packagers for generic pharmaceutical drug: raltegravir potassium
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raltegravir potassium
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | ISENTRESS | raltegravir potassium | POWDER;ORAL | 205786 | NDA | Merck Sharp & Dohme LLC | 0006-3603-60 | 60 PACKET in 1 CARTON (0006-3603-60) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01) | 2013-12-20 |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | POWDER;ORAL | 205786 | NDA | Merck Sharp & Dohme LLC | 0006-3603-61 | 60 PACKET in 1 CARTON (0006-3603-61) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01) | 2013-12-20 |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET, CHEWABLE;ORAL | 203045 | NDA | Merck Sharp & Dohme LLC | 0006-0473-61 | 60 TABLET, CHEWABLE in 1 BOTTLE (0006-0473-61) | 2011-12-21 |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET, CHEWABLE;ORAL | 203045 | NDA | Merck Sharp & Dohme LLC | 0006-0477-61 | 60 TABLET, CHEWABLE in 1 BOTTLE (0006-0477-61) | 2011-12-21 |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET;ORAL | 022145 | NDA | Merck Sharp & Dohme LLC | 0006-0227-61 | 60 TABLET, FILM COATED in 1 BOTTLE (0006-0227-61) | 2007-10-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Raltegravir Potassium
Introduction
Raltegravir potassium, marketed primarily under the trade name Isentress®, is an antiretroviral agent belonging to the class of HIV integrase strand transfer inhibitors (INSTIs). It is a critical component in combination antiretroviral therapy (ART) for treating HIV-1 infections, effectively suppressing viral replication and delaying disease progression. The global demand for raltegravir potassium is driven by extensive HIV treatment programs, and a robust supply chain is essential to ensure consistent availability for patients worldwide. This article provides an in-depth analysis of key suppliers involved in the manufacturing and distribution of raltegravir potassium, highlighting their capabilities, market reach, and strategic significance.
Manufacturers of Raltegravir Potassium
1. Merck & Co., Inc.
Overview:
Merck & Co., Inc., known outside North America as MSD, is the original developer and patent holder of raltegravir. The company introduced Isentress® into the market in 2007, solidifying its position as a leading supplier. Merck’s extensive pharmaceutical manufacturing infrastructure ensures high-quality production and a reliable supply chain.
Capabilities:
- Global manufacturing footprint: Merck operates multiple manufacturing centers globally, primarily in the United States, Europe, and Asia.
- Quality assurance: Stringent adherence to Good Manufacturing Practices (GMP) guarantees product consistency and regulatory compliance.
- Supply commitments: Merck maintains strategic inventory levels to support global distribution under long-term licensing and supply agreements.
Market Reach:
Merck’s distribution network spans over 150 countries, with authorized manufacturers and authorized generic partners in various regions, ensuring broad access to raltegravir products.
2. Mylan (Viatris Inc.)
Overview:
Mylan, now part of Viatris following its merger with Pfizer’s Upjohn unit in 2020, has been a significant producer of generic antiretroviral medications, including raltegravir potassium. Mylan’s experience in sterile injectables and oral formulations positions it as a key secondary supplier.
Capabilities:
- Generic manufacturing: Focused on providing cost-effective equivalents of branded drugs, Mylan/Viatris leverages extensive manufacturing expertise.
- Regulatory approvals: Mylan’s global presence enables swift registration in multiple jurisdictions, expanding access.
- Scale: Large-scale production facilities dedicated to antiretroviral generics bolster supply security.
Market Reach:
Distributed extensively across Africa, Asia, and Latin America, Mylan’s generics are vital for low- and middle-income countries (LMICs).
3. Dr. Reddy’s Laboratories
Overview:
An Indian-based pharmaceutical company, Dr. Reddy’s Laboratories, manufactures and distributes raltegravir potassium as part of its antiretroviral portfolio. It has an established reputation for quality generics and biosimilars.
Capabilities:
- Cost efficiency: Focused on affordable medicines for emerging markets.
- Manufacturing: Facilities in India and global regulatory approvals facilitate large-volume production.
- Quality compliance: Adheres to international GMP standards, ensuring high-quality products.
Market Reach:
Primarily serving Asia, Latin America, and Africa, Dr. Reddy’s provides strategic alternatives for facilitating supply in resource-constrained settings.
4. Sun Pharmaceutical Industries Ltd.
Overview:
Another key Indian pharmaceutical producer, Sun Pharma, has expanded its portfolio to include antiretroviral agents such as raltegravir potassium, focusing on bridging supply gaps in underserved markets.
Capabilities:
- Manufacturing scale: Extensive plant capacity for active pharmaceutical ingredients (APIs) and finished formulations.
- Cost competitiveness: Emphasizes affordable pricing solutions.
- Regulatory network: Approved by major global agencies, including USFDA, EMA, and WHO.
Market Reach:
Active across Africa, Southeast Asia, and Latin America, with growing presence in other emerging economies.
API and Drug Substance Suppliers
The critical raw material—Raltegravir active pharmaceutical ingredient (API)—is sourced from specialized API manufacturers. These companies supply both branded and generic manufacturers with high-quality APIs, ensuring scalability and consistent supply.
Notable API Suppliers
- Hetero Labs Ltd. (India): One of the largest API producers for antiretroviral drugs, Hetero supplies raltegravir API for many generic manufacturers.
- Sun Pharma Advanced Research Company (SPARC): Produces high-grade raltegravir API for global markets.
- Alvogen: Partners with API developers to source quality raltegravir intermediates and raw materials.
Distribution and Logistics Partners
Effective distribution relies on logistics providers with expertise in handling sensitive pharmaceuticals. Leading logistics firms such as DHL, UPS, and McKesson play vital roles in ensuring timely delivery, especially in regions with limited infrastructure. These partnerships are crucial for maintaining the integrity and availability of raltegravir products.
Regulatory and Licensing Considerations
Most suppliers and manufacturers operate under strict GMP guidelines compliant with international regulatory standards—such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO). Licensing agreements, especially concerning patent rights, influence supply dynamics. For instance, Merck’s patent protections historically limited generic production until patent expiry, after which numerous generics entered the market, expanding supply options.
Market Dynamics and Supply Challenges
The supply landscape for raltegravir potassium reflects broader trends in HIV medication production:
- Patent expiration: Opened opportunities for generic manufacturers, increasing global supply capacity.
- Pricing pressures: As generics dominate, competition has driven prices downward, making comprehensive supplier networks necessary to maintain margins and supply stability.
- Supply chain disruptions: Factors such as manufacturing delays, regulatory hurdles, and geopolitical issues can impact availability, emphasizing the importance of diversified suppliers.
Key Players and Strategic Alliances
Large pharmaceutical companies, often engaged in licensing agreements or regional manufacturing partnerships, dominate the supply chain. For example, Merck's licensing agreements with generic manufacturers in India and China have facilitated broader access, particularly in LMICs.
Strategic alliances involving API producers, formulators, and distributors have been essential to meet the rising demand and to mitigate supply risks. These collaborations also foster innovation in formulation and manufacturing processes, further strengthening the supply chain resilience.
Conclusion
The supply of raltegravir potassium hinges on a complex network of originators, generic manufacturers, API producers, and logistics providers. Merck remains the primary manufacturer and patent holder, with a significant influence on global availability. Meanwhile, a diversified portfolio of generics from companies like Mylan/Viatris, Dr. Reddy’s, and Sun Pharma ensures broader access, especially in resource-limited settings. The evolving landscape, characterized by patent expirations and increased competition, offers opportunities for cost reduction, yet poses challenges related to supply security.
A resilient and transparent supply chain, supported by international regulatory compliance and strategic partnerships, underpins the sustained availability of raltegravir potassium for millions living with HIV worldwide.
Key Takeaways
- Major Manufacturers: Merck & Co. remains the primary patent holder, with secondary supplies from Mylan/Viatris, Dr. Reddy’s, and Sun Pharma.
- API Supply: Indian and global API producers like Hetero and Sun Pharma are pivotal in ensuring production scale and quality.
- Global Reach: Suppliers serve diverse markets, with generics playing a vital role in expanding access in LMICs.
- Regulatory Compliance: International standards influence manufacturing and distribution resilience.
- Supply Risks: Patent status, geopolitical factors, and manufacturing logistics require continuous management to prevent shortages.
FAQs
1. Who is the patent holder of raltegravir potassium?
Merck & Co., Inc. holds the original patent rights for raltegravir, under the brand name Isentress®. Patent expiration has facilitated increased generic manufacturing.
2. Are there generic alternatives available for raltegravir potassium?
Yes, multiple generic manufacturers, including Mylan/Viatris, Dr. Reddy’s, and Sun Pharma, produce raltegravir potassium at reduced costs, expanding access, particularly in low-income countries.
3. What are the primary regions sourcing raltegravir API?
India is the leading supplier of raltegravir API, supported by companies like Hetero and Sun Pharma, with additional contributions from other Asian producers.
4. How do supply chain disruptions affect raltegravir availability?
Manufacturing delays, regulatory hurdles, and geopolitical issues can lead to shortages, underscoring the importance of diversified suppliers and strategic inventory management.
5. What regulatory standards govern the production of raltegravir?
Production must comply with GMP standards set by authorities like the FDA, EMA, and WHO to ensure safety, quality, and efficacy of the pharmaceutical product.
Sources:
- Merck Official Website
- Viatris Official Website
- Dr. Reddy's Laboratories
- Sun Pharma Official Website
- World Health Organization, WHO Prequalification of Medicines Programme
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