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Amoxicillin Trihydrate API Supplier USA — 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 USA. Our WHO GMP certified facility in Haridwar, India produces Amoxicillin Trihydrate in USP / BP / IP grade at ≥95.0% purity with full batch documentation.

The USA is the world’s largest pharmaceutical market. Generic API demand exceeds $50B annually.

Request Amoxicillin Trihydrate pricing for USA — 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 USA (FDA)

US API imports require FDA registration and cGMP compliance. Aarise provides DMF support for ANDA and NDA submissions.

Aarise provides the following documentation for USA 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 — FDA format
  • Impurity profile and residual solvents data
  • Stability data and shelf-life documentation
  • Certificate of Origin

Regulatory authority: U.S. Food and Drug Administration (FDA)

Documentation provided: cGMP-format COA, DMF (Drug Master File) support, FDA-format stability data, MSDS in GHS format


Why USA 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 FDA-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 USA — 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 FDA-compliant documentation?
Yes. All Amoxicillin Trihydrate orders for USA include FDA-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 USA 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 USA

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

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