How to Import Amlodipine Besylate API from India to Colombia — Complete Guide

This guide explains the complete process of importing Amlodipine Besylate API (CAS 111470-99-6) from India to Colombia, including INVIMA regulatory requirements, documentation, shipping options, and how to find a WHO GMP certified Indian supplier.

Why Import Amlodipine Besylate API from India?

India is the world’s largest supplier of generic pharmaceutical APIs, accounting for over 20% of global API exports. Indian manufacturers offer:

• Significantly lower manufacturing costs vs. European and Chinese suppliers
• WHO GMP, US FDA, and EMA-recognised quality standards
• Full pharmacopeial grade supply (USP, BP, IP) with NABL-accredited QC
• Complete regulatory documentation for all major markets including INVIMA
• Fast air freight delivery — 3-7 days to Colombia

Regulatory Requirements for Importing Amlodipine Besylate API into Colombia

To import Amlodipine Besylate API into Colombia, you must comply with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) regulations. The key requirements are: INVIMA sanitary registration, WHO GMP certificate acceptance for bulk APIs, local importer or distributor required.

Aarise Pharmaceuticals is WHO GMP certified and provides all documentation needed for INVIMA import compliance.

Step-by-Step Import Process

1. Identify a WHO GMP certified supplier — Aarise Pharmaceuticals (Haridwar, India) supplies 99.0% USP/BP grade Amlodipine Besylate API with full INVIMA-compliant documentation
2. Request samples and documentation — COA, MSDS, WHO GMP certificate, COPP for QC evaluation and regulatory pre-screening
3. Register with INVIMA or engage a local importer — INVIMA sanitary registration, WHO GMP certificate acceptance for bulk APIs, local importer or distributor required
4. Submit regulatory dossier — Aarise provides DMF support, stability data, and all required documentation
5. Place order and arrange shipping — air freight (3-7 days) or sea freight for bulk orders
6. Clear customs in Colombia — use the COA, COPP, and Certificate of Origin provided by Aarise

Shipping Amlodipine Besylate API from India to Colombia

• Air freight: 3-7 business days. Suitable for 1kg-100kg shipments. Temperature-controlled available.
• Sea freight: 18-30 days. Cost-effective for 100kg+ bulk orders. Full container or LCL available.
• Courier (DHL/FedEx): 2-5 days for sample quantities (10g-1kg)
• Incoterms: Ex-Works, FOB Mumbai, CIF Colombia — available on request

Documentation Aarise Provides for Colombia Import

• Batch Certificate of Analysis (COA)
• MSDS/SDS in GHS format
• WHO GMP Certificate (current)
• COPP (Certificate of Pharmaceutical Product)
• DMF filing support for INVIMA
• Certificate of Origin (for customs)
• Commercial invoice and packing list
• Stability data and shelf-life documentation

Ready to import Amlodipine Besylate API from India to Colombia? Contact Aarise Pharmaceuticals at +91 9899783330 for a quote, samples, and complete INVIMA documentation pack.

Frequently Asked Questions

How do I import Amlodipine Besylate API from India to Colombia?

To import Amlodipine Besylate API from India to Colombia: 1) Find a WHO GMP certified Indian supplier like Aarise Pharmaceuticals. 2) Request COA, MSDS, WHO GMP certificate, and COPP. 3) Register with INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) or work through a licensed local importer. 4) Submit the required dossier: INVIMA sanitary registration, WHO GMP certificate acceptance for bulk APIs, local importer or distributor required. 5) Arrange shipping via air freight (3-7 days) or sea freight.

What documents are needed to import Amlodipine Besylate API from India to Colombia?

Required documents: WHO GMP certificate from the Indian supplier, batch COA, MSDS/SDS, COPP (Certificate of Pharmaceutical Product), Certificate of Origin, commercial invoice, packing list, and DMF submission for INVIMA. Aarise Pharmaceuticals provides all of these with every order.

What is the import duty on Amlodipine Besylate API in Colombia?

Import duties on pharmaceutical APIs in Colombia vary by HS code. Amlodipine Besylate API typically falls under HS 2934 or 2936. Consult a Colombia-based customs broker for the current tariff rate. Aarise provides the correct HS code and country of origin documentation with every shipment.

How long does it take to import Amlodipine Besylate API from India to Colombia?

Air freight from Haridwar, India to Colombia takes 3-7 business days. Sea freight for bulk orders takes 18-30 days depending on the port. Aarise Pharmaceuticals dispatches within 7-10 days of order confirmation. Customs clearance in Colombia typically adds 2-5 business days.

Can I import Amlodipine Besylate API directly from India or do I need a local importer?

In most cases, INVIMA sanitary registration, WHO GMP certificate acceptance for bulk APIs, local importer or distributor required. Aarise Pharmaceuticals can connect you with established Colombia-based importers or distributors who have existing INVIMA registrations. Contact us at +91 9899783330 for introductions.