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Suppliers and packagers for NEXICLON XR
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NEXICLON XR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Athena | NEXICLON XR | clonidine | TABLET, EXTENDED RELEASE;ORAL | 022500 | NDA AUTHORIZED GENERIC | TruPharma, LLC | 52817-375-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52817-375-30) | 2024-01-11 |
| Athena | NEXICLON XR | clonidine | TABLET, EXTENDED RELEASE;ORAL | 022500 | NDA AUTHORIZED GENERIC | PALMETTO PHARMACEUTICALS INC. | 68134-603-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68134-603-30) | 2022-03-01 |
| Athena | NEXICLON XR | clonidine | TABLET, EXTENDED RELEASE;ORAL | 022500 | NDA | Athena Bioscience, LLC | 71511-503-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71511-503-30) | 2022-03-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NEXICLON XR
Introduction
NEXICLON XR is a pharmaceutical formulation belonging to the class of extended-release medications primarily containing the active ingredient clarithromycin. It is used to treat various bacterial infections, including respiratory tract infections, skin infections, and certain types of diarrhea, due to its broad-spectrum antimicrobial properties. As with many branded pharmaceuticals, NEXICLON XR's supply chain involves multiple stakeholders, including original manufacturers and generic producers, ensuring availability across markets. Understanding its suppliers provides insights into supply stability, manufacturing capacities, and competitive dynamics within the antibiotic sector.
Manufacturers and Original Equipment Suppliers
The initial and principal supplier of NEXICLON XR is Abbott Laboratories, a global pharmaceutical and health care giant. Abbott developed the extended-release formulation to enhance patient compliance and optimize pharmacokinetic profiles. The company's manufacturing facilities, primarily located in the United States, Ireland, and other strategic locations, produce the active pharmaceutical ingredient (API) and the finished dosage forms.
The NEXICLON XR tablets utilize proprietary controlled-release technologies, such as multiparticulate matrix systems and sophisticated coating techniques. Abbott's R&D and manufacturing divisions are responsible for developing these formulations, sourcing their APIs through integrated supply chains or external vendors complying with Good Manufacturing Practices (GMP).
API Suppliers for Clarithromycin
Clarithromycin itself has a complex synthesis pathway, often sourced from multiple API suppliers worldwide to ensure reliability and pricing competitiveness. Major suppliers for clarithromycin API include:
- Cipla Limited (India): one of the leading API producers, offering high-quality clarithromycin API globally.
- Zhejiang Hisun Pharmaceutical Co., Ltd. (China): a significant supplier for API components used in various antibiotics.
- Unichem Laboratories (India): providing APIs for both domestic and export markets.
- Teva Pharmaceutical Industries (Israel): offers APIs and finished dosage forms, including clarithromycin.
The API supply chain's robustness is critical, given potential disruptions like raw material shortages, regulatory changes, or geopolitical factors.
Excipient and Coating Material Suppliers
The extended-release technology relies on specialized excipients, including:
- Polymer coatings: such as ethyl cellulose, hydroxypropyl methylcellulose (HPMC), or enteric coatings, supplied by companies like Colorcon (USA) and Degussa (Evonik) (Germany).
- Particulate carriers: such as microcrystalline cellulose, provided by FMC (USA) and JRS Pharma (Germany).
- Binders, lubricants, and disintegrants: sourced from global excipient manufacturers.
These excipients are essential for ensuring the consistent release profile and stability of NEXICLON XR.
Contract Manufacturing and Packaging Partners
Abbott often outsources manufacturing to Contract Manufacturing Organizations (CMOs) to scale production efficiently. Notable CMOs involved in oral solid dosage forms include:
- Patheon (a part of Thermo Fisher Scientific): with facilities equipped for controlled-release formulations.
- Suven Life Sciences (India): involved in generic drug manufacturing.
Packaging materials, including blister packs, bottles, and tamper-evident seals, are sourced from specialized packaging suppliers like Essentra (UK) and Amcor (Australia).
Distribution and Logistics
Once manufactured, NEXICLON XR is distributed through a complex logistics network involving:
- Wholesalers and distributors in different regions (e.g., McKesson, AmerisourceBergen).
- Pharmaceutical importers and local distributors in target markets such as India, the U.S., Europe, and emerging economies.
Efficient logistics, quality compliance, and inventory management ensure steady supply and drug availability.
Market Dynamics and Supplier Relationships
The competitive landscape for NEXICLON XR's supply chain is characterized by:
- Patent protections: Abbott’s original patent grants exclusivity, limiting generic competition initially; however, patent expirations open markets for generics.
- Generic manufacturers: Once patent barriers lift, multiple companies—such as Mylan, Teva, and Cipla—enter the market with their versions, sourcing APIs from the same or alternative suppliers.
- Supply chain diversification: Companies increasingly diversify API and excipient sources to mitigate risks associated with geopolitical tensions, natural disasters, or regulatory crackdowns.
Regulatory Oversight and Quality Assurance
Suppliers involved in NEXICLON XR’s production must adhere to stringent regulatory standards defined by agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others. GMP compliance, validated manufacturing processes, and regular audits are mandatory to ensure consistent product quality.
Conclusion
The supply chain of NEXICLON XR encompasses complex interactions among API suppliers, excipient manufacturers, contract manufacturers, and logistics providers. Abbott Laboratories remains the original developer and primary supplier, but the broader ecosystem includes numerous global players, especially when considering generic alternatives. Ensuring supply stability involves strategic sourcing, diversified supplier relationships, and adherence to quality standards. As patent exclusivity periods evolve, the landscape may shift, impacting pricing, availability, and competitive positioning.
Key Takeaways
- Supply chain complexity: NEXICLON XR relies on a multi-tiered network of API suppliers, excipient manufacturers, and contract manufacturers.
- Primary stakeholders: Abbott Laboratories oversees the original formulation, utilizing globally sourced APIs and excipients.
- API sourcing: Major API suppliers include Cipla, Zhejiang Hisun, and Teva, with supply chain resilience crucial for consistent drug availability.
- Market dynamics: Patent protections influence supply exclusivity; post-expiry, increased generic manufacturing heightens competition.
- Regulatory compliance: Suppliers must meet strict GMP standards, impacting sourcing decisions and supply stability.
FAQs
-
Who are the main manufacturers of NEXICLON XR?
Abbott Laboratories is the primary manufacturer, responsible for production and formulation development of NEXICLON XR. -
What are the key raw material suppliers for NEXICLON XR?
Major suppliers include global API producers like Cipla, Zhejiang Hisun, and Teva for clarithromycin, along with excipient manufacturers such as Colorcon and FMC. -
How does patent expiry impact the supply of NEXICLON XR?
Patent expiration opens markets for generic competitors, increasing the number of suppliers, potentially reducing prices, and improving access. -
What role do contract manufacturing organizations play in NEXICLON XR’s supply chain?
CMOs handle scaled production, especially for generic versions, ensuring quality and capacity flexibility while Abbott manages core formulation and distribution. -
What are the risks associated with the supply chain of NEXICLON XR?
Risks include raw material shortages, geopolitical tensions affecting API sourcing, regulatory changes, and supply disruptions during crises like natural disasters or pandemics.
References
- Abbott Laboratories. (2022). NEXICLON XR Product Overview.
- U.S. Food and Drug Administration. (2023). Good Manufacturing Practices (GMP) Guidelines.
- GlobalData. (2022). Pharmaceutical Market and Drug Supply Chain Analysis.
- ChemSpider, Royal Society of Chemistry. (2023). API Synthesis Pathways.
- PatentDatabases and Market Reports on Clarithromycin and Extended-Release Antibiotics.
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