WHO GMP Certified API Supplier for Thailand — Aarise Pharmaceuticals India

Aarise Pharmaceuticals is a WHO GMP certified API supplier in Haridwar, India, exporting 100+ pharmacopeial grade APIs to pharmaceutical buyers in Thailand. Our WHO GMP certificate is issued by CDSCO India and accepted by FDA Thailand (Food and Drug Administration Thailand) for API import approval.

Our WHO GMP Certification

• Issuing Authority: CDSCO (Central Drugs Standard Control Organisation, India)
• Manufacturing Site: SIDCUL Industrial Area, Haridwar, Uttarakhand, India
• Scope: API manufacturing across all therapeutic categories
• Additional Certification: ISO 9001:2015, NABL-accredited QC Laboratory
• Accepted by: FDA Thailand, FDA, EMA, ANVISA, COFEPRIS, INVIMA, MFDS, SAHPRA, TGA

Why Thailand Buyers Require WHO GMP Certified APIs

FDA Thailand (Food and Drug Administration Thailand) requires: Thai FDA API import notification, GMP certificate, local Thai importer or agent required. A current WHO GMP certificate from the Indian manufacturer is a core document for FDA Thailand import clearance. Without it, customs clearance for pharmaceutical APIs in Thailand will be rejected.

WHO GMP Certified APIs for Thailand

All APIs from Aarise Pharmaceuticals are manufactured under WHO GMP conditions and supplied with a current GMP certificate. Key molecules include: Metformin HCl (USP/BP/IP), Dexamethasone (USP/BP/IP), Prednisolone (USP/BP/IP), Atorvastatin (USP/BP), Amoxicillin (USP/BP/IP), Ciprofloxacin (USP/BP), Testosterone Enanthate (USP/BP), Progesterone (USP/BP/IP), Omeprazole (USP/BP), Ibuprofen (USP/BP/IP), and 90+ more.

Documentation Package for Thailand

• WHO GMP Certificate (current, CDSCO India)
• Batch Certificate of Analysis (COA)
• MSDS / SDS (GHS format)
• COPP (Certificate of Pharmaceutical Product)
• DMF support for FDA Thailand
• Certificate of Origin
• Stability data and shelf-life documentation

To receive our WHO GMP certificate and a product list for Thailand, contact Aarise Pharmaceuticals at +91 9899783330. We send all pre-qualification documents within 24 hours.

Frequently Asked Questions

Is WHO GMP certification accepted for API imports in Thailand?

Yes. FDA Thailand (Food and Drug Administration Thailand) accepts WHO GMP certification from Indian API manufacturers as a basis for import approval. Thai FDA API import notification, GMP certificate, local Thai importer or agent required. Aarise Pharmaceuticals holds a current WHO GMP certificate issued by CDSCO India.

How do I verify a WHO GMP certificate from an Indian API supplier?

To verify a WHO GMP certificate from an Indian manufacturer: 1) Check the issuing authority — must be CDSCO (Central Drugs Standard Control Organisation, India). 2) Verify the certificate is current and covers the specific manufacturing site. 3) Confirm the scope covers the APIs you are purchasing. Aarise Pharmaceuticals provides GMP certificate copies and can facilitate verification through CDSCO records.

What WHO GMP certified APIs does Aarise Pharmaceuticals supply to Thailand?

Aarise Pharmaceuticals supplies 100+ WHO GMP certified APIs to Thailand including: Metformin HCl, Dexamethasone, Prednisolone, Atorvastatin, Amoxicillin, Ciprofloxacin, Azithromycin, Testosterone Enanthate, Progesterone, Omeprazole, Ibuprofen, Diclofenac, and more. All molecules available with full FDA Thailand-compliant documentation.

What documentation comes with WHO GMP certified APIs for Thailand?

Every WHO GMP certified API shipment to Thailand from Aarise includes: WHO GMP Certificate (current), batch COA per FDA Thailand specification, MSDS/SDS in GHS format, COPP, DMF support for FDA Thailand, Certificate of Origin, and stability data.

How long is a WHO GMP certificate valid for API supply to Thailand?

WHO GMP certificates issued by CDSCO India are typically valid for 3 years. Aarise Pharmaceuticals maintains a current WHO GMP certificate and provides copies with every export. Contact us to receive the current certificate and validity date for your FDA Thailand records.