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Montelukast Sodium API Supplier Netherlands — 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 Netherlands. Our WHO GMP certified facility in Haridwar, India produces Montelukast Sodium in USP / BP grade at ≥98.0% purity with full batch documentation.

Netherlands is a major European pharma hub — home to leading generic manufacturers and a key distribution centre for EU markets.

Request Montelukast Sodium pricing for Netherlands — 24 hour response:
Call: +91 9899783330 | +91 9289410333
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Montelukast Sodium — Technical Specifications

ParameterSpecification
CAS Number151767-02-1
Purity≥98.0%
GradeUSP / BP
CategoryLeukotriene Receptor Antagonist
Molecular Weight608.18 g/mol
Therapeutic UsePrevention and treatment of asthma and allergic rhinitis
Available Formstablets, chewable tablets, granules
StorageStore below 30°C, protect from light and moisture
Minimum Order500 g
Lead Time7–10 days

Regulatory Documentation for Netherlands (EMA / CBG-MEB)

As an EU member, Netherlands follows EMA GMP Directive. Rotterdam port is Europe’s largest API import hub.

Aarise provides the following documentation for Netherlands 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 / CBG-MEB format
  • Impurity profile and residual solvents data
  • Stability data and shelf-life documentation
  • Certificate of Origin

Regulatory authority: European Medicines Agency (EMA) and Medicines Evaluation Board (CBG-MEB)

Documentation provided: EU GMP COA, EDQM CEP support, EU-CTD format DMF, MSDS in English and Dutch


Why Netherlands Buyers Source Montelukast Sodium from Aarise

FactorAarise Advantage
CertificationWHO GMP certified facility, NABL-accredited QC lab
Purity≥98.0% — pharmacopeial specification (USP / BP)
DocumentationFull EMA / CBG-MEB-compliant dossier provided with every order
Minimum OrderFrom 500 g — sample orders welcome
Lead Time7–10 days standard — expedited available
PricingDirect manufacturer pricing — no middlemen
ShippingAir and sea freight to Netherlands — 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 / CBG-MEB-compliant documentation?
Yes. All Montelukast Sodium orders for Netherlands include EMA / CBG-MEB-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 Netherlands 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 Netherlands

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

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