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Buy Montelukast Sodium API in Poland | WHO GMP Certified India Supplier
Buy Montelukast Sodium API in Poland — WHO GMP Certified India Supplier
Looking to buy Montelukast Sodium API in Poland? Aarise Pharmaceuticals is a WHO GMP certified Montelukast Sodium API manufacturer based in Haridwar, India, supplying 98.5% purity USP/BP grade Montelukast Sodium (CAS 151767-02-1) to pharmaceutical buyers in Poland with full URPL/EMA-compliant documentation.
Why Buy Montelukast Sodium API from Aarise for Poland?
- WHO GMP Certified — our Haridwar facility is WHO GMP certified, accepted by URPL/EMA
- Pharmacopeial Grade — USP/BP grade, 98.5% purity, NABL-accredited QC testing
- Full URPL/EMA Documentation — COA, MSDS, COPP, DMF support, Certificate of Origin
- Competitive Pricing — direct manufacturer, no middlemen, best ex-works rates
- Fast Delivery — air freight 3-7 days to Poland; 7-10 days lead time
- Small MOQ — from 500 g; samples from 10g available
Montelukast Sodium API Specifications
| Parameter | Specification |
|---|---|
| Chemical Name | Montelukast Sodium |
| CAS Number | 151767-02-1 |
| Purity | 98.5% (USP/BP) |
| Therapeutic Category | Respiratory / Leukotriene Antagonist |
| Primary Use | Asthma and allergic rhinitis management |
| Dosage Forms | tablets, chewable tablets, granules |
| MOQ | 500 g |
| Lead Time | 7-10 days |
| Packaging | HDPE drums / double polylined fibre drums |
Buying Montelukast Sodium API in Poland — Regulatory Requirements
To import Montelukast Sodium API into Poland, buyers must comply with URPL (Office for Registration of Medicinal Products) under EMA framework requirements: EU GMP or EMA-recognised WHO GMP, EU qualified person for import, Poland is a major generic drug manufacturing hub in Central Europe. Aarise Pharmaceuticals provides all required documentation to support your URPL/EMA import clearance.
Documentation Provided with Every Order
- Batch-specific Certificate of Analysis (COA) — signed by QC head
- MSDS / SDS in GHS format (English)
- WHO GMP Certificate (current)
- Certificate of Pharmaceutical Product (COPP)
- DMF support for URPL/EMA
- Certificate of Origin
- Stability data and shelf-life documentation
- Packing list and commercial invoice
How to Place an Order
- Contact Aarise Pharmaceuticals at +91 9899783330 or submit an inquiry online
- Receive a proforma invoice with pricing and delivery terms
- Request a free sample (10-50g) for your QC team evaluation
- Confirm the order and receive complete regulatory documentation
- Shipment dispatched within 7-10 days — air freight to Poland in 3-7 days
Ready to buy Montelukast Sodium API for Poland? Contact us at +91 9899783330 or +91 9289410333 for pricing, samples, and a URPL/EMA-compliant documentation pack. We respond within 24 hours.
Frequently Asked Questions
Where can I buy Montelukast Sodium API in Poland?
You can buy Montelukast Sodium API (CAS 151767-02-1) for Poland directly from Aarise Pharmaceuticals, a WHO GMP certified manufacturer in Haridwar, India. We supply URPL/EMA-compliant Montelukast Sodium API with full COA, MSDS, and DMF documentation. Contact us at +91 9899783330.
What is the price of Montelukast Sodium API in Poland?
The price of Montelukast Sodium API for Poland depends on quantity, grade (USP/BP/IP), and delivery terms. MOQ starts from 500 g. Contact Aarise Pharmaceuticals for an ex-works price and CIF Poland quote.
Is Montelukast Sodium API available for import into Poland?
Yes. Aarise Pharmaceuticals exports Montelukast Sodium API to Poland with full URPL/EMA-compliant documentation including WHO GMP certificate, COA, MSDS, COPP, and DMF support. We have experience with URPL/EMA import requirements.
What documentation is provided when buying Montelukast Sodium API for Poland?
Every order includes: batch-specific COA, WHO GMP certificate, MSDS/SDS (GHS format), COPP, Certificate of Origin, DMF support for URPL/EMA, and stability data. All documents are provided in English and formatted for URPL/EMA submission.
What is the minimum order quantity to buy Montelukast Sodium API?
Minimum order quantity for Montelukast Sodium API is 500 g. Samples from 10-50g are available for QC evaluation and regulatory filing. Lead time is 7-10 days from order confirmation.