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Amoxicillin Trihydrate API Supplier Germany — WHO GMP Certified | Aarise Pharmaceuticals

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Aarise Pharmaceuticals supplies Amoxicillin Trihydrate (CAS 61336-70-7) to pharmaceutical manufacturers, distributors, and importers in Germany. Our WHO GMP certified facility in Haridwar, India produces Amoxicillin Trihydrate in USP / BP / IP grade at ≥95.0% purity with full batch documentation.

Germany is Europe’s largest pharmaceutical market and a key entry point for EU-wide API distribution.

Request Amoxicillin Trihydrate pricing for Germany — 24 hour response:
Call: +91 9899783330 | +91 9289410333
Send Inquiry →


Amoxicillin Trihydrate — Technical Specifications

Parameter Specification
CAS Number 61336-70-7
Purity ≥95.0%
Grade USP / BP / IP
Category Antibiotic / Beta-Lactam
Molecular Weight 419.45 g/mol
Therapeutic Use Treatment of bacterial infections
Available Forms capsules, tablets, oral suspensions, dispersible tablets
Storage Store below 25°C, protect from moisture
Minimum Order 1 kg
Lead Time 7–10 days

Regulatory Documentation for Germany (EMA / BfArM)

EU API imports require compliance with EU GMP Directive 2001/83/EC. Aarise provides EU-CTD format dossiers and EDQM CEP support.

Aarise provides the following documentation for Germany importers:

  • Batch-specific Certificate of Analysis (COA) — HPLC purity confirmed, NABL-accredited lab
  • MSDS / SDS in GHS format
  • WHO GMP Certificate (facility)
  • Certificate of Pharmaceutical Product (COPP)
  • Drug Master File (DMF) support — EMA / BfArM format
  • Impurity profile and residual solvents data
  • Stability data and shelf-life documentation
  • Certificate of Origin

Regulatory authority: European Medicines Agency (EMA) and Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Documentation provided: EU GMP-equivalent COA, EDQM CEP support where applicable, EMA-format MSDS, DMF (EU-CTD format)


Why Germany Buyers Source Amoxicillin Trihydrate from Aarise

Factor Aarise Advantage
Certification WHO GMP certified facility, NABL-accredited QC lab
Purity ≥95.0% — pharmacopeial specification (USP / BP / IP)
Documentation Full EMA / BfArM-compliant dossier provided with every order
Minimum Order From 1 kg — sample orders welcome
Lead Time 7–10 days standard — expedited available
Pricing Direct manufacturer pricing — no middlemen
Shipping Air and sea freight to Germany — full export documentation

Frequently Asked Questions

Can I get a COA and MSDS before placing a bulk order?
Yes. Aarise provides batch-specific COA and MSDS before any order commitment. Sample quantity available from 50–100g.

Do you provide EMA / BfArM-compliant documentation?
Yes. All Amoxicillin Trihydrate orders for Germany include EMA / BfArM-format COA, WHO GMP certificate, COPP, and MSDS. DMF support available on request.

What is the minimum order quantity for Amoxicillin Trihydrate?
Minimum order is 1 kg. Sample orders from 50–100g for qualification purposes. Contact us for bulk pricing above 10 kg.

How long does delivery to Germany take?
Air freight: 3–5 business days from dispatch. Sea freight: 18–25 days. Standard lead time from order to dispatch is 7–10 days.

Is your Amoxicillin Trihydrate suitable for finished dosage form manufacturing?
Yes. Our Amoxicillin Trihydrate is USP / BP / IP grade at ≥95.0% purity — suitable for capsules, tablets, oral suspensions, dispersible tablets and all standard finished dosage form manufacturing.


Request Amoxicillin Trihydrate Quote for Germany

Specify: quantity required, grade (USP / BP / IP), target delivery timeline, and any EMA / BfArM-specific documentation requirements.

Call: +91 9899783330 | +91 9289410333
Send Inquiry Form →
Aarise Pharmaceuticals | WHO GMP Certified Amoxicillin Trihydrate Supplier | Haridwar, India | aarisepharma.com