Steroid API Supplier for US — Import Guide & Sourcing from India

US Market Demand for Steroid APIs from India

The United States is the world’s largest pharmaceutical market, and India supplies over 40% of its generic drug needs. Demand for steroid APIs in the US spans corticosteroids, anti-inflammatory formulations, and hormone therapies. Aarise Pharmaceuticals is a trusted steroid API supplier for the US, exporting pharmaceutical-grade steroid raw materials from India with FDA-ready documentation.

Steroid APIs for the US Market

Corticosteroid APIs

• Prednisolone — Anti-inflammatory and immunosuppressive formulations
• Dexamethasone — Emergency medicine and respiratory care
• Hydrocortisone — OTC topical and prescription formulations
• Betamethasone Dipropionate — Prescription topical steroid
• Budesonide — Inhaled corticosteroid for asthma
• Fluticasone Propionate — Nasal and inhaled steroid

Anabolic Steroid APIs (Schedule III)

• Testosterone Enanthate — FDA-approved HRT API
• Nandrolone Decanoate — Prescription therapeutic API
• Oxandrolone — FDA-approved for weight gain after surgery/infection

Steroid Intermediates

• DHEA — Steroid synthesis intermediate (dietary supplement grade available)
• Pregnenolone — Precursor for pharmaceutical steroid production

FDA Compliance & Documentation

Exporting steroid APIs to the US requires stringent compliance:

• Drug Master File (DMF) — Filed with FDA for each API
• cGMP Compliance — Manufacturing per 21 CFR Parts 210/211
• Certificate of Analysis — USP/EP methodology testing
• FDA Facility Registration — Manufacturing site registered with FDA
• DEA Compliance — Required for Schedule III anabolic steroid APIs

Import Process for Steroid APIs into the US

1. FDA Prior Notice — Submit electronic prior notice before shipment
2. Customs Entry — File FDA entry with CBP at port of arrival
3. FDA Examination — Possible physical inspection or sampling
4. DEA Import Permit — Required for controlled steroid substances
5. Release — FDA releases shipment for domestic distribution

Pricing & Logistics

• Competitive pricing — India’s manufacturing cost advantage
• Air freight to major US ports (5-7 days)
• Sea freight for bulk (18-22 days to East Coast, 25-30 to West Coast)
• Sample orders from 100g with full COA
• Annual supply contracts with price stability

Contact Aarise — Steroid APIs for the US

Request a quote for steroid APIs for the US from India. FDA-ready documentation, competitive pricing, and reliable supply.