INVIMA Approved API Suppliers from India — WHO GMP Certified

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer supplying pharmacopeial grade APIs that meet INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) import requirements for Colombia. We provide complete INVIMA-ready documentation with every order.

Our INVIMA Compliance

INVIMA sanitary registration and WHO GMP certificate for API imports. Aarise Pharmaceuticals satisfies all these requirements:

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

APIs Available for INVIMA-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 INVIMA-ready documentation.

INVIMA Documentation Package

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

For a INVIMA-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 INVIMA approved?

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer whose products meet INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) import requirements for Colombia. INVIMA sanitary registration and WHO GMP certificate for API imports. Contact us at +91 9899783330 for our INVIMA-ready documentation pack.

What documentation does INVIMA require for API imports from India?

INVIMA requires: INVIMA sanitary registration and WHO GMP certificate 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 INVIMA submission.

Is Indian API acceptable for INVIMA registration?

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

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

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

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

INVIMA 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 INVIMA-specific guidance on your required molecule.