Last updated: June 2, 2026
AUGMENTIN ES-600 suppliers: Which manufacturers make the antibiotic suspension and who supplies ingredients?
Who manufactures AUGMENTIN ES-600 (amoxicillin/clavulanate) suspension?
AUGMENTIN ES-600 is an amoxicillin/clavulanate oral suspension product line marketed in the US by GlaxoSmithKline (GSK) (brand ownership). The specific finished-dose manufacturer(s) and site-level suppliers vary by lot and distribution channel, and are typically reflected on the product label, package insert, and regulatory listing materials submitted to FDA.
What is the active ingredient and what ingredient suppliers supply amoxicillin and clavulanate?
AUGMENTIN ES-600 contains:
- Amoxicillin (API): β-lactam antibiotic
- Clavulanic acid (API): β-lactamase inhibitor
API supply chains for amoxicillin and clavulanic acid are global and generally involve:
- Bulk API producers (amoxicillin trihydrate or other specified form, and clavulanic acid or its defined stabilized form)
- Custom synthesis and fermentation-derived intermediates upstream
- Contract manufacturing organizations that formulate and fill oral suspensions under GMP
Finished-dose supplier and API supplier identification for AUGMENTIN ES-600 at the level of named companies is determined by the FDA facility and label manufacturing information tied to the specific dosage form and strength, plus the current Orange Book listing for the reference listed drug and related FDA assignment records. Without the specific Orange Book/RLD reference entry and the FDA label/manufacturing data for ES-600, supplier names cannot be stated accurately at the level of named suppliers.
Which contract manufacturers (CMOs) make AUGMENTIN ES-600 for GSK or distributors?
For oral suspension products in the Augmentin ES line, the manufacturing model commonly splits into:
- Drug product manufacturing and sterile-free fill-finish (suspension compounding, filling, packaging)
- Relabeling/distribution through regional wholesalers
- Lot release by the sponsor or its quality unit
The exact CMO(s) and site(s) for AUGMENTIN ES-600 can be identified only from the current US label “Manufactured for/Distributed by” and “Manufactured by” facility statements and corresponding FDA listing records.
How to identify AUGMENTIN ES-600 suppliers from FDA and labeling?
What Orange Book record maps to AUGMENTIN ES-600 for supplier tracking?
To determine supplier identity with legal and sourcing accuracy, the workflow uses:
- FDA Orange Book listing for the reference listed drug (RLD) corresponding to the specific ES-600 suspension strength and dosage form
- FDA “Application” and “Labeler” mapping to the sponsor and listed manufacturing sites
- Labeling statements for “Manufactured for” / “Manufactured by” and the facility address
This yields the named manufacturer(s) for the finished product and links to facility identifiers.
Where are supplier names embedded on AUGMENTIN ES-600 packaging and inserts?
Supplier naming is typically found in:
- “Manufactured for” and “Distributed by” lines on the carton and bottle
- “Manufactured by” line(s) on the bottle label
- Package insert section listing manufacturer/labeler and address
- FDA drug listing tied to the National Drug Code (NDC)
What suppliers matter most for AUGMENTIN ES-600 sourcing: API, excipients, and fill-finish?
API suppliers: What is the supply risk profile for amoxicillin/clavulanate?
Key supply constraints for the class include:
- Fermentation and penicillin-derived feedstock availability
- Clavulanic acid stabilization and yield variability in fermentation processes
- Controlled intermediates for β-lactam synthesis
- Regulatory scrutiny for quality and residual impurities
In practice, sourcing risk is managed through:
- Multi-source qualification for APIs
- Dual-source excipients and suspension stabilizers
- Qualified CMO redundancy for compounding and filling
Excipients and suspension components that drive CMO capability
Oral suspension manufacture requires suppliers and specifications for:
- Buffering system
- Viscosity agents and suspending agents
- Sweeteners and flavorants (often multiple licensed flavor systems)
- Stabilizers for β-lactams in suspension
- Packaging compatibility (bottle type, closure system, and protection from moisture/light)
Supplier selection is reflected in the formulation and the quality system, even when the APIs are identical across lots.
Does AUGMENTIN ES-600 have direct generic or AB-rated alternatives that compete on supplier?
How do generic entry risks affect supplier landscape?
Supplier landscape shifts when:
- Competitors launch generics or authorized generics using different CMOs
- API market prices move due to fermentation capacity or regulatory actions
- Product availability constraints lead to substitution of equivalent strengths and dosage forms
But the specific supplier mapping for ES-600 depends on the RLD labeling and current manufacturing sites, which are not determinable from the prompt alone.
Key Takeaways
- AUGMENTIN ES-600 is a GSK marketed product line with amoxicillin/clavulanate active ingredients.
- Supplier identification at the level of named finished-dose manufacturers and API producers requires the current US FDA labeler/manufacturing-site and Orange Book-linked RLD entry for the ES-600 suspension.
- Without the exact FDA-linked RLD record and current label manufacturing statements for ES-600, supplier names cannot be stated accurately.
FAQs
- What is the reference listed drug (RLD) for AUGMENTIN ES-600 in the Orange Book?
- How can I confirm the finished-dose manufacturing site for AUGMENTIN ES-600 on the bottle label?
- Who supplies amoxicillin trihydrate and clavulanic acid for US oral suspension markets?
- What excipients are critical for stable amoxicillin/clavulanate suspensions?
- How do manufacturing-site changes affect AUGMENTIN ES-600 supply continuity and lot availability?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
- FDA. Drug Registration and Listing (DRLS). US FDA.
- GSK. AUGMENTIN ES-600 prescribing information and US labeling (manufacturer/labeler statements).
