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Montelukast Sodium API Supplier Mexico — WHO GMP Certified | Aarise Pharmaceuticals
Aarise Pharmaceuticals supplies Montelukast Sodium (CAS 151767-02-1) to pharmaceutical manufacturers, distributors, and importers in Mexico. Our WHO GMP certified facility in Haridwar, India produces Montelukast Sodium in USP / BP grade at ≥98.0% purity with full batch documentation.
Mexico has one of the most active generic drug markets in LATAM with over 200 pharmaceutical manufacturers.
Request Montelukast Sodium pricing for Mexico — 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 Mexico (COFEPRIS)
Mexico requires COFEPRIS API authorization. Aarise provides Spanish-language documentation and COFEPRIS dossier support.
Aarise provides the following documentation for Mexico 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 — COFEPRIS format
- Impurity profile and residual solvents data
- Stability data and shelf-life documentation
- Certificate of Origin
Regulatory authority: Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
Documentation provided: COFEPRIS-compatible COA and MSDS in Spanish, WHO GMP certificate, DMF support
Why Mexico 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 COFEPRIS-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 Mexico — 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 COFEPRIS-compliant documentation?
Yes. All Montelukast Sodium orders for Mexico include COFEPRIS-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 Mexico 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 Mexico
Specify: quantity required, grade (USP / BP), target delivery timeline, and any COFEPRIS-specific documentation requirements.
Call: +91 9899783330 | +91 9289410333
Send Inquiry Form →
Aarise Pharmaceuticals | WHO GMP Certified Montelukast Sodium Supplier | Haridwar, India | aarisepharma.com