ANVISA Approved API Suppliers from India — WHO GMP Certified

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer supplying pharmacopeial grade APIs that meet ANVISA (Agencia Nacional de Vigilancia Sanitaria) import requirements for Brazil. We provide complete ANVISA-ready documentation with every order.

Our ANVISA Compliance

ANVISA GMP certification or WHO GMP acceptance for API imports. Aarise Pharmaceuticals satisfies all these requirements:

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

APIs Available for ANVISA-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 ANVISA-ready documentation.

ANVISA Documentation Package

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

For a ANVISA-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 ANVISA approved?

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer whose products meet ANVISA (Agencia Nacional de Vigilancia Sanitaria) import requirements for Brazil. ANVISA GMP certification or WHO GMP acceptance for API imports. Contact us at +91 9899783330 for our ANVISA-ready documentation pack.

What documentation does ANVISA require for API imports from India?

ANVISA requires: ANVISA GMP certification or WHO GMP acceptance for API imports. Aarise Pharmaceuticals provides: WHO GMP certificate (CDSCO India), batch COA, MSDS/SDS, COPP, DMF support, Certificate of Origin, and stability data — all formatted for ANVISA submission.

Is Indian API acceptable for ANVISA registration?

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

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

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

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

ANVISA 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 ANVISA-specific guidance on your required molecule.