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Montelukast Sodium API Supplier Germany — WHO GMP Certified | Aarise Pharmaceuticals
Aarise Pharmaceuticals supplies Montelukast Sodium (CAS 151767-02-1) to pharmaceutical manufacturers, distributors, and importers in Germany. Our WHO GMP certified facility in Haridwar, India produces Montelukast Sodium in USP / BP grade at ≥98.0% purity with full batch documentation.
Germany is Europe’s largest pharmaceutical market and a key entry point for EU-wide API distribution.
Request Montelukast Sodium pricing for Germany — 24 hour response:
Call: +91 9899783330 | +91 9289410333
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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 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 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 EMA / BfArM-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 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 Montelukast Sodium 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 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 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 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 Germany
Specify: quantity required, grade (USP / BP), target delivery timeline, and any EMA / BfArM-specific documentation requirements.
Call: +91 9899783330 | +91 9289410333
Send Inquiry Form →
Aarise Pharmaceuticals | WHO GMP Certified Montelukast Sodium Supplier | Haridwar, India | aarisepharma.com