FDA Approved API Suppliers from India — WHO GMP Certified

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer supplying pharmacopeial grade APIs that meet FDA (Food and Drug Administration) import requirements for USA. We provide complete FDA-ready documentation with every order.

Our FDA Compliance

FDA Type II Drug Master File and facility registration. Aarise Pharmaceuticals satisfies all these requirements:

• WHO GMP Certificate: Current, CDSCO India — accepted by FDA
• NABL-Accredited QC Lab: All analytical testing done in-house to pharmacopeial standards
• DMF Support: Full Drug Master File preparation and submission support for FDA
• Complete Documentation: COA, MSDS, COPP, COO, stability data — all FDA-formatted
• Export Experience: Active supply to USA with FDA import clearance track record

APIs Available for FDA-Regulated Markets

100+ molecules available including: Metformin HCl, Dexamethasone, Prednisolone, Atorvastatin, Rosuvastatin, Amoxicillin, Ciprofloxacin, Azithromycin, Metronidazole, Testosterone Enanthate, Progesterone, Estradiol, Omeprazole, Pantoprazole, Ibuprofen, Diclofenac, Hydrocortisone, Amlodipine, Losartan, Montelukast — all in USP/BP/IP grade with full FDA-ready documentation.

FDA Documentation Package

• WHO GMP Certificate (CDSCO India) — accepted by FDA
• Batch Certificate of Analysis (COA) — per FDA specification
• MSDS / SDS in GHS format
• COPP (Certificate of Pharmaceutical Product)
• Drug Master File (DMF) support for FDA submission
• Certificate of Origin (India)
• Stability data (ICH Q1A) and shelf-life documentation

For a FDA-ready documentation pack and API quotation, contact Aarise Pharmaceuticals at +91 9899783330. We respond within 24 hours.

Frequently Asked Questions

Which Indian API suppliers are FDA approved?

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer whose products meet FDA (Food and Drug Administration) import requirements for USA. FDA Type II Drug Master File and facility registration. Contact us at +91 9899783330 for our FDA-ready documentation pack.

What documentation does FDA require for API imports from India?

FDA requires: FDA Type II Drug Master File and facility registration. Aarise Pharmaceuticals provides: WHO GMP certificate (CDSCO India), batch COA, MSDS/SDS, COPP, DMF support, Certificate of Origin, and stability data — all formatted for FDA submission.

Is Indian API acceptable for FDA registration?

Yes. FDA accepts APIs from WHO GMP certified Indian manufacturers. India is one of the top API-supplying countries for USA and FDA has established processes for Indian API import clearance. Aarise Pharmaceuticals has experience with FDA documentation requirements.

How do I submit a DMF to FDA for an Indian API?

Aarise Pharmaceuticals provides Drug Master File (DMF) support for FDA submissions, including technical dossier preparation, API characterisation data, manufacturing process details, and QC specifications. Our regulatory team guides you through the FDA DMF submission process. Contact us at +91 9899783330.

How long does FDA approval take for API imports from India?

FDA approval timelines vary by registration pathway. In many cases, WHO GMP certified Indian APIs can be imported immediately under a simplified notification process while full registration is pending. Contact Aarise Pharmaceuticals for FDA-specific guidance on your required molecule.