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Montelukast Sodium API Supplier Brazil — WHO GMP Certified | Aarise Pharmaceuticals

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Aarise Pharmaceuticals supplies Montelukast Sodium (CAS 151767-02-1) to pharmaceutical manufacturers, distributors, and importers in Brazil. Our WHO GMP certified facility in Haridwar, India produces Montelukast Sodium in USP / BP grade at ≥98.0% purity with full batch documentation.

Brazil is Latin America’s largest pharmaceutical market with over 90,000 pharmacies and a growing generics sector.

Request Montelukast Sodium pricing for Brazil — 24 hour response:
Call: +91 9899783330 | +91 9289410333
Send Inquiry →


Montelukast Sodium — Technical Specifications

Parameter Specification
CAS Number 151767-02-1
Purity ≥98.0%
Grade USP / BP
Category Leukotriene Receptor Antagonist
Molecular Weight 608.18 g/mol
Therapeutic Use Prevention and treatment of asthma and allergic rhinitis
Available Forms tablets, chewable tablets, granules
Storage Store below 30°C, protect from light and moisture
Minimum Order 500 g
Lead Time 7–10 days

Regulatory Documentation for Brazil (ANVISA)

Brazil requires ANVISA API registration (CBPF) for imported APIs. Aarise provides full ANVISA dossier support.

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

Regulatory authority: Agência Nacional de Vigilância Sanitária (ANVISA)

Documentation provided: ANVISA-format COA, IFA supplier documentation in Portuguese, WHO GMP certificate with apostille


Why Brazil Buyers Source Montelukast Sodium from Aarise

Factor Aarise Advantage
Certification WHO GMP certified facility, NABL-accredited QC lab
Purity ≥98.0% — pharmacopeial specification (USP / BP)
Documentation Full ANVISA-compliant dossier provided with every order
Minimum Order From 500 g — sample orders welcome
Lead Time 7–10 days standard — expedited available
Pricing Direct manufacturer pricing — no middlemen
Shipping Air and sea freight to Brazil — 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 ANVISA-compliant documentation?
Yes. All Montelukast Sodium orders for Brazil include ANVISA-format COA, WHO GMP certificate, COPP, and MSDS. DMF support available on request.

What is the minimum order quantity for Montelukast Sodium?
Minimum order is 500 g. Sample orders from 50–100g for qualification purposes. Contact us for bulk pricing above 10 kg.

How long does delivery to Brazil 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 Montelukast Sodium suitable for finished dosage form manufacturing?
Yes. Our Montelukast Sodium is USP / BP grade at ≥98.0% purity — suitable for tablets, chewable tablets, granules and all standard finished dosage form manufacturing.


Request Montelukast Sodium Quote for Brazil

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

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