EMA Approved API Suppliers from India — WHO GMP Certified

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer supplying pharmacopeial grade APIs that meet EMA (European Medicines Agency) import requirements for EU (Germany, Netherlands, Poland). We provide complete EMA-ready documentation with every order.

Our EMA Compliance

EU GMP or EMA-recognised WHO GMP certificate, qualified person for import. Aarise Pharmaceuticals satisfies all these requirements:

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

APIs Available for EMA-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 EMA-ready documentation.

EMA Documentation Package

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

For a EMA-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 EMA approved?

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer whose products meet EMA (European Medicines Agency) import requirements for EU (Germany, Netherlands, Poland). EU GMP or EMA-recognised WHO GMP certificate, qualified person for import. Contact us at +91 9899783330 for our EMA-ready documentation pack.

What documentation does EMA require for API imports from India?

EMA requires: EU GMP or EMA-recognised WHO GMP certificate, qualified person for import. Aarise Pharmaceuticals provides: WHO GMP certificate (CDSCO India), batch COA, MSDS/SDS, COPP, DMF support, Certificate of Origin, and stability data — all formatted for EMA submission.

Is Indian API acceptable for EMA registration?

Yes. EMA accepts APIs from WHO GMP certified Indian manufacturers. India is one of the top API-supplying countries for EU (Germany, Netherlands, Poland) and EMA has established processes for Indian API import clearance. Aarise Pharmaceuticals has experience with EMA documentation requirements.

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

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

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

EMA 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 EMA-specific guidance on your required molecule.