MFDS Approved API Suppliers from India — WHO GMP Certified

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer supplying pharmacopeial grade APIs that meet MFDS (Ministry of Food and Drug Safety) import requirements for South Korea. We provide complete MFDS-ready documentation with every order.

Our MFDS Compliance

MFDS API import notification and WHO GMP certificate. Aarise Pharmaceuticals satisfies all these requirements:

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

APIs Available for MFDS-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 MFDS-ready documentation.

MFDS Documentation Package

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

For a MFDS-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 MFDS approved?

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer whose products meet MFDS (Ministry of Food and Drug Safety) import requirements for South Korea. MFDS API import notification and WHO GMP certificate. Contact us at +91 9899783330 for our MFDS-ready documentation pack.

What documentation does MFDS require for API imports from India?

MFDS requires: MFDS API import notification 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 MFDS submission.

Is Indian API acceptable for MFDS registration?

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

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

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

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

MFDS 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 MFDS-specific guidance on your required molecule.