TGA Approved API Suppliers from India — WHO GMP Certified

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer supplying pharmacopeial grade APIs that meet TGA (Therapeutic Goods Administration) import requirements for Australia. We provide complete TGA-ready documentation with every order.

Our TGA Compliance

TGA overseas GMP clearance (OGC) and Australian sponsor. Aarise Pharmaceuticals satisfies all these requirements:

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

APIs Available for TGA-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 TGA-ready documentation.

TGA Documentation Package

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

For a TGA-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 TGA approved?

Aarise Pharmaceuticals is a WHO GMP certified Indian API manufacturer whose products meet TGA (Therapeutic Goods Administration) import requirements for Australia. TGA overseas GMP clearance (OGC) and Australian sponsor. Contact us at +91 9899783330 for our TGA-ready documentation pack.

What documentation does TGA require for API imports from India?

TGA requires: TGA overseas GMP clearance (OGC) and Australian sponsor. Aarise Pharmaceuticals provides: WHO GMP certificate (CDSCO India), batch COA, MSDS/SDS, COPP, DMF support, Certificate of Origin, and stability data — all formatted for TGA submission.

Is Indian API acceptable for TGA registration?

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

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

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

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

TGA 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 TGA-specific guidance on your required molecule.