API Suppliers in USA from India — WHO GMP Certified

Looking for Indian API suppliers for USA? Aarise Pharmaceuticals is a WHO GMP certified active pharmaceutical ingredient (API) manufacturer in Haridwar, India, supplying 100+ molecules to pharmaceutical buyers in USA with full FDA-compliant documentation. The world’s largest pharmaceutical market worth over $500 billion annually.

Why Source APIs from India for USA?

• India exports APIs to 200+ countries and is the world’s largest generic API manufacturer
• 30-60% cost advantage over European API suppliers
• WHO GMP certification accepted by FDA
• Full pharmacopeial grade (USP/BP/IP) with NABL-accredited QC
• Complete FDA-ready documentation with every order
• Air freight delivery to USA in 3-7 days

APIs Available for USA

Aarise Pharmaceuticals supplies the following categories of APIs to USA:

• Antidiabetics: Metformin HCl, Glimepiride
• Corticosteroids: Dexamethasone, Prednisolone, Hydrocortisone, Betamethasone
• Antibiotics: Amoxicillin, Ciprofloxacin, Azithromycin, Metronidazole
• Cardiovascular: Atorvastatin, Rosuvastatin, Amlodipine, Losartan
• Hormones: Testosterone Enanthate, Progesterone, Estradiol
• NSAIDs: Ibuprofen, Diclofenac Sodium
• PPIs: Omeprazole, Pantoprazole
• Respiratory: Montelukast Sodium

Regulatory Compliance for USA

All Aarise APIs are supplied with full FDA import documentation: FDA Drug Master File (Type II DMF) submission, facility registration with FDA, prior notice for imports, US agent appointment. Our WHO GMP certificate is current and accepted by FDA (Food and Drug Administration).

Documentation for USA Import

• Batch Certificate of Analysis (COA)
• MSDS / SDS (GHS format)
• WHO GMP Certificate
• COPP (Certificate of Pharmaceutical Product)
• DMF support for FDA
• Certificate of Origin

To source APIs from India for USA, contact Aarise Pharmaceuticals at +91 9899783330. We respond within 24 hours with product list, pricing, and a documentation sample.

Frequently Asked Questions

Which Indian API suppliers export to USA?

Aarise Pharmaceuticals is a WHO GMP certified API supplier exporting to USA with FDA-compliant documentation. We supply 100+ API molecules including Metformin, Dexamethasone, Atorvastatin, Amoxicillin, Ciprofloxacin, Testosterone Enanthate, and more. Contact us at +91 9899783330.

How do I find a reliable API supplier for USA?

To find a reliable Indian API supplier for USA: 1) Verify WHO GMP certification from CDSCO India. 2) Check NABL accreditation for QC lab. 3) Request COA, MSDS, and COPP for your required molecules. 4) Confirm FDA export experience and documentation capability. Aarise Pharmaceuticals meets all these criteria.

What APIs can I source from India for USA?

India manufactures over 500 API molecules. From Aarise Pharmaceuticals, you can source: Metformin HCl, Atorvastatin, Dexamethasone, Prednisolone, Amoxicillin, Ciprofloxacin, Azithromycin, Testosterone Enanthate, Progesterone, Omeprazole, Ibuprofen, Losartan, Pantoprazole, Diclofenac, Hydrocortisone, Estradiol, Amlodipine, Rosuvastatin, Montelukast, Metronidazole — and additional molecules on request.

Do Indian API suppliers provide FDA-compliant documentation?

Yes. WHO GMP certified Indian API suppliers like Aarise Pharmaceuticals provide full FDA-compliant documentation: COA, MSDS, WHO GMP certificate, COPP, DMF support, and Certificate of Origin. FDA Drug Master File (Type II DMF) submission, facility registration with FDA, prior notice for imports, US agent appointment.

What is the minimum order when buying API from Indian suppliers for USA?

MOQ varies by molecule. Most APIs start from 1 kg. Corticosteroids and hormones from 100-500g. Samples from 10g available for QC evaluation. Contact Aarise Pharmaceuticals at +91 9899783330 for specific molecule MOQs and pricing for USA.