COFEPRIS Approved API Suppliers from India — WHO GMP Certified

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer supplying pharmacopeial grade APIs that meet COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios) import requirements for Mexico. We provide complete COFEPRIS-ready documentation with every order.

Our COFEPRIS Compliance

COFEPRIS API import permit and WHO GMP certificate. Aarise Pharmaceuticals satisfies all these requirements:

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

APIs Available for COFEPRIS-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 COFEPRIS-ready documentation.

COFEPRIS Documentation Package

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

For a COFEPRIS-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 COFEPRIS approved?

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer whose products meet COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios) import requirements for Mexico. COFEPRIS API import permit and WHO GMP certificate. Contact us at +91 9899783330 for our COFEPRIS-ready documentation pack.

What documentation does COFEPRIS require for API imports from India?

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

Is Indian API acceptable for COFEPRIS registration?

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

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

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

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

COFEPRIS 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 COFEPRIS-specific guidance on your required molecule.