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Suppliers and packagers for AUGMENTIN XR
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AUGMENTIN 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 |
|---|---|---|---|---|---|---|---|---|---|
| Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785 | NDA AUTHORIZED GENERIC | USAntibiotics, LLC | 81964-220-28 | 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-28) | 2025-12-15 |
| Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785 | NDA AUTHORIZED GENERIC | USAntibiotics, LLC | 81964-220-40 | 40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-40) | 2025-12-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AUGMENTIN XR
Executive Summary
Augmentin XR (Extended Release) is a combination antibiotic containing amoxicillin and clavulanic acid, used to treat various bacterial infections. As a high-demand, branded pharmaceutical with extensive clinical indications, Augmentin XR relies on a complex global supply chain involving multiple API (Active Pharmaceutical Ingredient) producers, excipient providers, and finished drug manufacturers. This article offers a comprehensive analysis of suppliers involved in the production of Augmentin XR, including key API manufacturers, formulation specialists, and distribution channels. It examines the supply landscape, regulatory implications, and strategic considerations for stakeholders in the pharmaceutical supply chain.
What Is Augmentin XR and Why Is Its Supply Chain Critical?
Augmentin XR combines amoxicillin with clavulanic acid in an extended-release formulation to overcome bacterial resistance and improve patient compliance. Its success hinges on a robust, compliant supply chain that ensures consistent quality, regulatory adherence, and global distribution.
Key attributes:
- API Content: Amoxicillin and clavulanic acid
- Formulation: Extended-release tablet
- Patent/Trademark: Belongs to GlaxoSmithKline (GSK), with generic versions available post-patent expiry
- Clinical Uses: Respiratory, urinary tract, skin infections
Demand drivers include increased prevalence of bacterial infections and antibiotic stewardship initiatives, making reliable supply vital.
Who Are the Major API Suppliers for Augmentin XR?
The API supply chain's backbone comprises several global manufacturers, many located in China, India, and Europe. These suppliers must adhere to strict regulatory standards, including Good Manufacturing Practices (GMP), to meet international quality demands.
Table 1: Key API Suppliers for Amoxicillin and Clavulanic Acid
| Supplier Name | Location | API Focus | Market Share (Estimated) | Regulatory Certifications | Notes |
|---|---|---|---|---|---|
| Zhejiang Huahai Pharmaceutical | China | Amoxicillin | ~35% | USFDA, EMA, China NMPA | Major supplier, faced recall issues in 2018-19 |
| Zhejiang Hisun Pharmaceuticals | China | Clavulanic Acid | 20-25% | GMP, USFDA, EMA | Key supplier for European and North American markets |
| Aurobindo Pharma | India | Amoxicillin | 10-15% | USFDA, EDQM, WHO-GMP | Supplies both API and finished dosage formulations |
| Sandoz (Novartis) | Switzerland / India | Clavulanic Acid | 5-10% | USFDA, EUGMP | Focuses on high-quality API production |
| TEVA Pharmaceuticals | Israel / India | Amoxicillin | 5-8% | USFDA, EMA | Major generic manufacturer, involved in supply stabilization |
Notes:
- API raw material synthesis involves complex processes, especially for clavulanic acid, which requires fermentation and purification.
- Suppliers face geopolitical and regulatory challenges, affecting global supply stability.
Formulation and Finished Goods Manufacturers
While API production is crucial, finished dosage form manufacturing involves specialized pharmaceutical companies.
Major Pharmaceutical Companies Producing Augmentin XR
| Manufacturer | Location | Market Focus | Notable Fact | Regulatory Status |
|---|---|---|---|---|
| GlaxoSmithKline (GSK) | UK / Global | Original patent holder, branded product | Developed the XR formulation | EMA, USFDA, MHRA, WHO |
| Teva Pharmaceuticals | Israel / India | Generics | Significant generic Augmentin production | USFDA, EMA, Health Canada |
| Sandoz (Novartis) | Switzerland / India | Generic versions | Dosed in multiple markets | USFDA, EMA |
| Mylan / Pfizer / Others | Various | Regional generic manufacturing | Diverse supply chain partners | Regional approvals |
Regulatory Landscape and Impact on Suppliers
API manufacturers and finished drug producers must navigate regulatory frameworks:
- USFDA: Inspects APIs and FDF (Finished Dosage Form) manufacturing facilities; issues Drug Master Files (DMFs).
- EMA (European Medicines Agency): Approves manufacturing sites serving the EU.
- NMPA (China): Regulates Chinese API suppliers; recent reforms aim to improve GMP standards.
- WHO-GMP: International compliance necessary for export to developing markets.
Notably, Zhejiang Huahai’s recall in 2018-19 highlighted the importance of regulatory adherence, affecting global supply chains and spurring quality improvements.
Supply Chain Challenges and Risks
- Raw Material Shortages: Fluctuations in the availability of key precursor chemicals, especially for clavulanic acid fermentation.
- Manufacturing Disruptions: Plant shutdowns, quality issues, or geopolitical tensions impacting China and India-based suppliers.
- Regulatory Barriers: Revocation or delay of certifications affecting API exports.
- Patent and Exclusivity: While GSK retains rights, generic competition depends on patent expiry timelines.
- Pricing Pressures: Competition from generics influences supplier margins and capacity investments.
Why Are Strategic Supplier Relationships Critical?
- Quality Assurance: Consistent API purity and potency to ensure efficacy.
- Regulatory Compliance: Meeting differing certifications across markets.
- Supply Continuity: Buffer stock, multiple sourcing, and risk mitigation.
- Cost Management: Navigating geopolitical tariffs, exchange rates, and economies of scale.
Table 2: Supply Chain Best Practices for Augmentin XR Stakeholders
| Practice | Description | Benefit |
|---|---|---|
| Multiple Sourcing | Engaging several API suppliers to mitigate risk | Ensures supply continuity |
| Vertical Integration | Partnering with API manufacturers with integrated facilities | Enhanced quality control |
| Regulatory Vigilance | Continuous monitoring of compliance status | Avoids sanctions or recalls |
| Inventory Buffering | Maintaining safety stock levels | Reduces stockouts |
| Supply Chain Transparency | Real-time tracking and auditing | Greater risk management |
Comparison: Branded vs. Generic Suppliers
| Aspect | Branded (GSK) | Generic Suppliers |
|---|---|---|
| Brand Recognition | High | Variable |
| Regulatory Stringency | High (due to patent) | Varies, often through DMFs |
| Price and Cost | Typically higher | Competitive, lower margins |
| Supply Stability | Generally robust (large scale) | Risk-dependent, capacity constraints |
| Innovation & Formulation | Proprietary XR formulations | Replicate existing formulations |
Conclusion: Global Outlook and Strategic Implications
The supply chain for Augmentin XR exemplifies the complexity inherent in producing a reliable, high-quality antibiotic. Suppliers from China, India, and Switzerland dominate API manufacturing, with a continually evolving regulatory landscape shaping supplier viability. Pharmaceutical companies must cultivate diversified, compliant supplier networks to ensure consistent patient access and maintain market competitiveness.
Key Takeaways
- The API supply landscape for Augmentin XR is concentrated primarily in China and India, with Chinese manufacturers holding significant market share.
- API quality and regulatory compliance are vital; past incidents have prompted stricter oversight.
- Multiple suppliers and strategic partnerships diminish risks related to manufacturing disruptions, geopolitical influences, and regulatory non-compliance.
- Finished drug formulations depend on both original patent holders like GSK and generic manufacturers, with pricing, quality, and supply being critical considerations.
- Continuous monitoring of global regulatory developments and supply chain resilience strategies are essential for market stakeholders.
FAQs
1. Who are the leading API suppliers for Augmentin XR?
The primary API suppliers include Zhejiang Huahai Pharmaceutical and Zhejiang Hisun Pharmaceuticals from China, with additional contributions from Aurobindo Pharma and TEVA from India.
2. What are the main risks facing Augmentin XR’s supply chain?
Risks encompass raw material shortages, regulatory non-compliance, geopolitical tensions, manufacturing disruptions, and patent expiries affecting generic market entry.
3. How does regulatory compliance impact API suppliers?
Regulatory standards such as USFDA, EMA, and WHO-GMP dictate quality requirements, influencing supplier approval, export capability, and market access.
4. Are there significant differences between branded and generic Augmentin XR?
Yes. Branded versions (GSK) typically have guaranteed supply and advanced formulations, whereas generics may vary in quality, formulation, and supply stability but generally offer cost advantages.
5. What strategic measures can pharmaceutical companies adopt to secure Augmentin XR supply?
Implementing multiple sourcing, engaging in long-term partnerships, maintaining safety stock, and monitoring regulatory landscapes are key strategies to mitigate supply chain risks.
References
[1] USFDA Drug Master Files Database, 2023.
[2] European Medicines Agency (EMA), 2023. Regulatory overview of API manufacturing standards.
[3] Zhejiang Huahai Pharmaceutical Annual Report, 2022.
[4] "Global API Market Report," IQVIA, 2022.
[5] World Health Organization (WHO), GMP guidelines, 2022.
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