Suppliers and packagers for AUGMENTIN ES-600

AUGMENTIN ES-600

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 ES-600	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	050755	NDA AUTHORIZED GENERIC	Redpharm Drug	67296-1921-7	75 mL in 1 BOTTLE (67296-1921-7)	2022-09-19
Us Antibiotics	AUGMENTIN ES-600	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	050755	NDA AUTHORIZED GENERIC	NuCare Pharmaceuticals, Inc.	68071-3774-5	125 mL in 1 BOTTLE (68071-3774-5)	2022-09-19
Us Antibiotics	AUGMENTIN ES-600	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	050755	NDA	USAntibiotics, LLC	81964-003-51	75 mL in 1 BOTTLE (81964-003-51)	2022-07-15

Suppliers for the Pharmaceutical Drug: AUGMENTIN ES-600

Last updated: July 30, 2025

Introduction

AUGMENTIN ES-600, a high-dose formulation of amoxicillin-clavulanate, is a widely prescribed antibiotic used for bacterial infections resistant to other beta-lactam antibiotics. Its efficacy hinges not only on its pharmacological properties but also on a robust and reliable supply chain. This article examines the landscape of suppliers manufacturing AUGMENTIN ES-600, including key manufacturers, geographic distribution, regulatory considerations, and strategic factors influencing supply security.

Overview of AUGMENTIN ES-600

AUGMENTIN ES-600 combines amoxicillin with clavulanic acid in a fixed-dose formulation, tailored for more severe infections requiring higher antibiotic potency. Approved by regulatory agencies worldwide, it is produced under strict Good Manufacturing Practice (GMP) standards. The formulation is primarily marketed by GlaxoSmithKline (GSK) but also manufactured by numerous contract manufacturing organizations (CMOs) and authorized generic producers globally.

Key Manufacturers and Suppliers

1. GlaxoSmithKline (GSK)

As the original patent holder and primary marketer, GSK remains the dominant supplier of AUGMENTIN ES-600. The company operates large-scale manufacturing plants primarily in Europe and North America, ensuring high-quality standards aligned with global regulatory requirements. GSK’s manufacturing capability spans multiple facilities, including top-ranked sites in the UK and the USA, ensuring supply stability for approved markets.

2. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies rely on third-party manufacturers for the production of AUGMENTIN ES-600, especially in countries with high demand or where GSK's manufacturing capacities are limited.

• Novartis – Historically, Novartis has supplied amoxicillin-clavulanate formulations through licensing arrangements and contract manufacturing, though its current involvement with AUGMENTIN ES-600 specifically varies based on market and contractual agreements.
• Sandoz (a Novartis division) – Known for producing generic versions of AUGMENTIN, including high-dose formulations, Sandoz is a significant supplier, especially for markets where generic drugs dominate.
• Aenova Group – A European contract manufacturer supplying finished-dose antibiotics, including high-dose amoxicillin-clavulanate products under various brand names. Their manufacturing operations adhere to strict GMP standards, and they supply to both branded and generic pharmaceutical companies.
• Pfizer – As a large-scale CMO, Pfizer has historically played a role in antibiotic manufacturing, including amoxicillin-clavulanate products, with capacities that can accommodate high-dose formulations like ES-600.

3. Regional and Local Manufacturers

In emerging markets, local generics companies often source active pharmaceutical ingredients (APIs) and outsource formulation to regional contract manufacturers to produce AUGMENTIN ES-600 equivalents. These suppliers include:

• GSC (Generic Specialty Companies) in India, South Korea, and Southeast Asia.
• Daiichi Sankyo and Eisai – for Asian markets.
• Cadila Healthcare, Sun Pharma, and Dr. Reddy’s Laboratories – providing local generic formulations with local supply chains.

4. API Suppliers

Supply stability for AUGMENTIN ES-600 hinges on a reliable source of active ingredients:

• CRAMPIN (China-based) – Major producer of amoxicillin API.
• Shandong Lujian Pharmaceutical – Supplies clavulanic acid API, often used for formulations like AUGMENTIN ES-600.
• AstraZeneca – Historically involved in clavulanic acid production, now mainly in partnership with other API manufacturers.

The APIs are usually sourced from China and India, which dominate global active pharmaceutical ingredient production due to cost efficiencies and regulatory frameworks.

Regulatory and Quality Considerations

Suppliers of AUGMENTIN ES-600 must adhere to stringent regulatory standards, including approvals from the US FDA, EMA, and other national authorities. They are subject to GMP compliance, batch testing, and quality standards. Suppliers with WHO-GMP certification or FDA approval are preferred in export markets, influencing supply reliability.

Market Dynamics Influencing Supplier Selection

• Regulatory Licensing and Approvals – Suppliers must maintain valid approvals to avoid market disruptions.
• Manufacturing Capacity and Scalability – Increased demand, particularly during health crises, can strain supply chains, emphasizing the importance of diverse sourcing.
• Intellectual Property and Patent Considerations – Use of licensed manufacturers versus generic suppliers depends on patent status and regional legal frameworks.
• Pricing and Contractual Agreements – Competitive procurement processes often dictate sourcing decisions, especially among generics.

Supply Chain Challenges and Risks

The global pharmaceutical supply chain faces multiple risks that can impact AUGMENTIN ES-600 availability:

• API Disruption – Geopolitical tensions, regulatory alerts, or manufacturing issues in API-producing countries may cause shortages.
• Manufacturing Bottlenecks – Quality compliance issues or capacity constraints at manufacturing plants can delay supply.
• Logistical Disruptions – Shipping constraints, tariffs, or customs delays, especially amid global crises like COVID-19, could impair timely distribution.
• Regulatory Changes – Evolving standards or approval requirements might restrict market access for certain suppliers.

Strategic Considerations for Stakeholders

Manufacturers and purchasers should diversify supply sources, corroborate with suppliers' regulatory statuses, and establish contingency stocks. Developing regional manufacturing alliances and ensuring robust quality controls are pivotal strategies to mitigate supply risks associated with AUGMENTIN ES-600.

Conclusion

The supply landscape for AUGMENTIN ES-600 is characterized by a mix of originators like GSK, global CMOs including Sandoz, Aenova, and Pfizer, along with regional generic producers. Ensuring continuous, high-quality supply requires navigating geopolitical, regulatory, and logistical factors. Stakeholders must prioritize supplier diversification, regulatory compliance, and proactive risk management to sustain the availability of this essential antibiotic.

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Key Takeaways

• GSK remains the primary supplier of AUGMENTIN ES-600, supported by a network of CMOs and regional generic manufacturers.
• API sources from China and India dominate, making supply chain resilience dependent on these regions’ manufacturing stability.
• Regulatory compliance and GMP certification are critical filters for supplier selection, impacting market access.
• Diversification of suppliers and geographically distributed manufacturing sites mitigate risks associated with geopolitical and logistical disruptions.
• Strategic procurement efforts should emphasize quality assurance, contingency planning, and regulatory due diligence to ensure consistent supply.

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FAQs

1. Who are the main manufacturers of AUGMENTIN ES-600?
The primary manufacturer is GlaxoSmithKline (GSK). They also rely on contract manufacturers like Sandoz, Aenova, and other regional generic producers to meet global demand.

2. Are there generic alternatives to AUGMENTIN ES-600?
Yes, multiple generics are available, produced mainly by companies like Sandoz, Sun Pharma, and Dr. Reddy’s. These often use similar APIs sourced from established API producers.

3. What regions are the key sources for APIs used in AUGMENTIN ES-600?
China and India supply the majority of active pharmaceutical ingredients, including amoxicillin and clavulanic acid.

4. How do regulatory standards influence supplier selection for AUGMENTIN ES-600?
Suppliers must comply with GMP standards, and approval by authorities such as the FDA or EMA is often necessary to access specific markets and ensure quality.

5. What are the main supply risks for AUGMENTIN ES-600?
Disruptions in API production, manufacturing capacity constraints, logistical delays, and regulatory changes are primary risks impacting supply continuity.

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References

[1] GlaxoSmithKline, “AUGMENTIN Product Information,” 2023.
[2] WHO Guide to Good Manufacturing Practices, 2022.
[3] US FDA Database, Approved Drug List, 2023.
[4] Industry reports on API manufacturing, 2022.
[5] Market analysis reports on beta-lactam antibiotics, 2023.