Montelukast Sodium API Manufacturer for Brazil — WHO GMP Certified India

Aarise Pharmaceuticals is a WHO GMP certified Montelukast Sodium API manufacturer in Haridwar, India, supplying USP/BP grade Montelukast Sodium (CAS 151767-02-1) to pharmaceutical companies in Brazil. We are a direct manufacturer — not a trader — with a NABL-accredited QC laboratory and full ANVISA-ready documentation.

About Our Montelukast Sodium API Manufacturing

• Manufacturing Site: SIDCUL Industrial Area, Haridwar, Uttarakhand, India
• Certification: WHO GMP (current), ISO 9001:2015
• QC Lab: NABL-accredited — all testing done in-house
• Grade: USP/BP pharmacopeial grade at 98.5% purity
• Capacity: 100g samples to multi-tonne commercial batches
• Lead Time: 7-10 days standard

Why Choose Aarise as Your Montelukast Sodium API Manufacturer for Brazil?

• Direct manufacturer pricing — no broker or agent markup
• WHO GMP certified — accepted by ANVISA
• NABL-accredited QC — batch-specific COA from certified analysts
• ANVISA-ready documentation — COA, MSDS, COPP, DMF support, COO
• Dedicated export team — experienced in Brazil import compliance
• Fast delivery — air freight to Brazil in 3-7 days

Manufacturing Compliance for Brazil Market

Our Montelukast Sodium API manufacturing complies with ANVISA (Agencia Nacional de Vigilancia Sanitaria) requirements. ANVISA GMP certification or WHO GMP acceptance, local importer registration, ANVISA product registration for finished goods. We provide all documentation needed for ANVISA import clearance, including DMF filing support.

Quality Control — Montelukast Sodium API

• HPLC purity testing — 98.5% minimum
• Impurity profiling per USP/BP pharmacopeial specification
• Residual solvents — ICH Q3C compliant
• Heavy metals — ICH Q3D compliant
• Stability testing — ICH Q1A compliant
• Microbial testing where applicable

To qualify Aarise Pharmaceuticals as your Montelukast Sodium API manufacturer for Brazil, contact us at +91 9899783330. We provide GMP certificates, facility information, audit-ready documentation, and free samples within 24 hours of request.

Frequently Asked Questions

Which is the best Montelukast Sodium API manufacturer for Brazil?

Aarise Pharmaceuticals is a WHO GMP certified Montelukast Sodium API manufacturer in Haridwar, India, supplying 98.5% USP/BP grade Montelukast Sodium (CAS 151767-02-1) to buyers in Brazil with full ANVISA-compliant documentation. We are a direct manufacturer with NABL-accredited QC — no intermediaries.

Are Indian Montelukast Sodium API manufacturers ANVISA approved?

WHO GMP certified Indian manufacturers like Aarise Pharmaceuticals are recognised by ANVISA for API imports. ANVISA GMP certification or WHO GMP acceptance, local importer registration, ANVISA product registration for finished goods. We provide all required documentation for smooth ANVISA import clearance.

How do I verify a Montelukast Sodium API manufacturer in India?

Verify a Montelukast Sodium API manufacturer by: 1) Checking their WHO GMP certificate (current, from Central Drugs Standard Control Organisation India). 2) Requesting a facility audit or inspection report. 3) Verifying NABL accreditation for QC laboratory. 4) Checking COA against pharmacopeial specifications (USP/BP). Aarise Pharmaceuticals provides all verification documents on request.

What is the manufacturing capacity for Montelukast Sodium API at Aarise?

Aarise Pharmaceuticals has dedicated manufacturing capacity for Montelukast Sodium API at our Haridwar facility. We can supply from 100g sample quantities to multi-tonne commercial batches. Lead time is 7-10 days for standard orders. Contact us for capacity confirmation for large-volume requirements.

Can I visit the Montelukast Sodium API manufacturing facility before ordering?

Yes. Aarise Pharmaceuticals welcomes facility audits and pre-qualification visits at our Haridwar, Uttarakhand facility. We can also provide an audit-ready documentation pack (GMP certificate, facility layout, QC SOP list, batch records) for remote quality assessment. Contact us at +91 9899783330 to schedule a visit.