WHO GMP Certified API Supplier for Australia — Aarise Pharmaceuticals India

Aarise Pharmaceuticals is a WHO GMP certified API supplier in Haridwar, India, exporting 100+ pharmacopeial grade APIs to pharmaceutical buyers in Australia. Our WHO GMP certificate is issued by CDSCO India and accepted by TGA (Therapeutic Goods Administration) 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: TGA, FDA, EMA, ANVISA, COFEPRIS, INVIMA, MFDS, SAHPRA, TGA

Why Australia Buyers Require WHO GMP Certified APIs

TGA (Therapeutic Goods Administration) requires: TGA API import permit, TGA-recognised GMP certificate or overseas GMP clearance (OGC), Australian sponsor required. A current WHO GMP certificate from the Indian manufacturer is a core document for TGA import clearance. Without it, customs clearance for pharmaceutical APIs in Australia will be rejected.

WHO GMP Certified APIs for Australia

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 Australia

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

To receive our WHO GMP certificate and a product list for Australia, 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 Australia?

Yes. TGA (Therapeutic Goods Administration) accepts WHO GMP certification from Indian API manufacturers as a basis for import approval. TGA API import permit, TGA-recognised GMP certificate or overseas GMP clearance (OGC), Australian sponsor 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 Australia?

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

What documentation comes with WHO GMP certified APIs for Australia?

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

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

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 TGA records.