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Amoxicillin 500mg hard gelatin capsules in white HDPE bottle
EU-GMP Antibiotic · Penicillin In stock

Amoxicillin Capsules 500mg

INN: Amoxicillin trihydrate · Dosage form: Capsule, hard

Pack
10×10 / 1000ct
MOQ
100,000 caps
Lead Time
25–35 days
Shelf Life
36 months
Registration
EU-GMP, WHO PQ
HS Code
3004.10
Request Quote Request CTD Dossier
Full CTD dossier
COA per batch
Door-to-door export

Product Identification

INN (Generic Name)Amoxicillin
Chemical Name(2S,5R,6R)-6-{[(2R)-2-amino-2-phenylacetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate
CAS Number61336-70-7
Molecular FormulaC₁₆H₁₉N₃O₅S·3H₂O
Molecular Weight419.45 g/mol
ATC CodeJ01CA04
PharmacopoeiaPh. Eur. / USP / BP / IP

Dosage & Packaging

Strength500 mg amoxicillin (as trihydrate)
Dosage FormHard gelatin capsule, size 0, opaque white
IndicationsRespiratory, ENT, urinary, skin & soft-tissue infections; Helicobacter pylori eradication
Adult Dose250–500 mg every 8h, or 500–875 mg every 12h
Primary PackPVC/Alu blister, 10×10 / 1000 caps per shipper
StorageBelow 25°C, dry place, protect from light
Shelf Life36 months from manufacture date

Regulatory & Supply

GMP StatusEU-GMP certified manufacturing site (audit reports on request)
RegistrationsEU-GMP, WHO Prequalification, GCC, 18 country dossiers
CTD DossierModules 1–5 available in ACTD / EU-CTD / US-FDA format
MOQ100,000 capsules (≈100 shippers)
Lead Time25–35 days from PO + down-payment clearance
IncotermsEXW / FOB / CIF / DDP (cold-chain optional)
HS Code3004.10 (Penicillins, dosage form)

Quality & Traceability

Batch Size1.0M capsules (commercial); 0.5M (validation)
Release TestingAssay, related substances, dissolution, microbial per Ph. Eur.
Stability DataLong-term 25°C/60% RH (36 mo) + accelerated 40°C/75% RH (6 mo)
SerializationGS1 2D Data Matrix, end-to-end traceability ready
CoA / CoCPer-batch Certificate of Analysis + Certificate of Conformity
LabelingMultilingual insert leaflets (EN/FR/ES/AR/RU) on request
Carton PrintCustom artwork, GTIN, batch, expiry, barcode, 2D matrix

Product Overview

Amoxicillin 500 mg capsules are a broad-spectrum β-lactam antibiotic formulated for oral solid dosage. Produced at our EU-GMP facility under full GMP controls, each batch is released against Ph. Eur. and USP monographs and is supported by a complete CTD dossier for fast in-country registration.

Indications & Pharmacology

Amoxicillin inhibits bacterial cell-wall synthesis (PBP binding) and is bactericidal against a wide range of Gram-positive and Gram-negative organisms. Indicated for:

  • Upper & lower respiratory tract infections (pharyngitis, sinusitis, bronchitis, community-acquired pneumonia)
  • Acute otitis media & ENT infections
  • Urinary tract infections (cystitis, pyelonephritis)
  • Skin & soft-tissue infections
  • Helicobacter pylori eradication (triple therapy)
  • Endocarditis prophylaxis (dental procedures)

Quality & Manufacturing

Manufactured in an ISO-7 / Class 10,000 cleanroom with full HVAC, environmental monitoring and serialization. Each batch passes HPLC assay, related-substances, dissolution and microbial testing against the current Ph. Eur. monograph.

  • DMF available in ACTD / EU-CTD / FDA format
  • Bioequivalence study data on file
  • Stability: long-term 25°C/60% RH, accelerated 40°C/75% RH
  • Serialization-ready per GS1 2D Data Matrix
EU-GMP cleanroom production line for oral solid dosage at Healthrow Pharma

Supply & Logistics

Standard production lead time is 25–35 days. For recurring tenders we offer reserved-capacity slots, scheduled rolling batches, and door-to-door DDP shipping to 60+ countries including cold-chain lanes for adjacent injectables.

  • EXW Hangzhou / FOB Shanghai / CIF destination port / DDP
  • Multilingual inserts (EN/FR/ES/AR/RU) on request
  • Custom artwork, GTIN, and barcode integration
  • Letter of Credit, T/T 30/70, OA for vetted partners
Automated blister packaging line with serialization and cartonation
CTD Dossier (Module 1–5)
PDFEU-CTD format18.4 MBEN
Download
Certificate of Analysis (Sample)
PDFPer-batch available220 KBEN
Download
Material Safety Data Sheet (MSDS)
PDFGHS compliant380 KBEN
Download
EU-GMP Certificate
PDFIssued by EU authority1.2 MBEN
Download
Prescribing Information (SmPC)
PDFEN/FR/ES/AR/RU540 KB
Download

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