Pharmaceutical API Supplier for US — Complete Import & Sourcing Guide

India — America’s Largest API Supplier

India supplies over 40% of generic drugs consumed in the United States, making it the single largest source of pharmaceutical APIs for American manufacturers. Aarise Pharmaceuticals is a trusted pharmaceutical API supplier for the US, offering a comprehensive range of bulk drug substances with FDA-ready documentation.

API Categories for US Market

Analgesic & Anti-inflammatory

• Acetaminophen (Paracetamol) — #1 OTC analgesic in the US
• Ibuprofen — Leading NSAID API
• Naproxen Sodium — Long-acting anti-inflammatory
• Diclofenac — Prescription NSAID API

Gastrointestinal

• Omeprazole — OTC and prescription PPI
• Esomeprazole Magnesium — Next-gen PPI API
• Pantoprazole Sodium — Prescription PPI

Cardiovascular & Metabolic

• Metformin HCl — First-line diabetes API (#4 most prescribed drug in US)
• Atorvastatin Calcium — #1 statin API
• Lisinopril — ACE inhibitor API
• Amlodipine Besylate — Calcium channel blocker

Respiratory

• Montelukast Sodium — Asthma/allergy management
• Cetirizine HCl — OTC antihistamine API
• Fluticasone Propionate — Inhaled corticosteroid

FDA Import Requirements

1. Drug Master File (DMF) — Type II DMF filed with FDA
2. cGMP Compliance — 21 CFR Parts 210/211
3. FDA Facility Registration — Biennial registration required
4. Prior Notice — Electronic filing before shipment
5. FDA Import Alert Check — Ensure no active alerts on supplier
6. CBP Entry — Customs declaration at port of entry

Why Source APIs from India for US Market?

• Cost savings of 40-70% compared to US/European manufacturing
• FDA-inspected facilities — India has 600+ FDA-approved API plants
• Proven supply chain — decades of India-US pharmaceutical trade
• Scale flexibility — kg to multi-ton quantities

Logistics

• Air freight 4-6 days to East/West Coast
• Sea freight 18-30 days depending on port
• FOB/CIF/DDP pricing options
• Temperature-controlled shipping available

Contact Aarise — APIs for the US

Get a quote for pharmaceutical APIs for the US from India. DMF, COA, cGMP documentation — all within 24 hours.