Atorvastatin Calcium API Manufacturer for Australia — WHO GMP Certified India

Aarise Pharmaceuticals is a WHO GMP certified Atorvastatin Calcium API manufacturer in Haridwar, India, supplying USP/BP grade Atorvastatin Calcium (CAS 134523-03-8) to pharmaceutical companies in Australia. We are a direct manufacturer — not a trader — with a NABL-accredited QC laboratory and full TGA-ready documentation.

About Our Atorvastatin Calcium API Manufacturing

• Manufacturing Site: SIDCUL Industrial Area, Haridwar, Uttarakhand, India
• Certification: WHO GMP (current), ISO 9001:2015
• QC Lab: NABL-accredited — all testing done in-house
• Grade: USP/BP pharmacopeial grade at 98.0% purity
• Capacity: 100g samples to multi-tonne commercial batches
• Lead Time: 7-10 days standard

Why Choose Aarise as Your Atorvastatin Calcium API Manufacturer for Australia?

• Direct manufacturer pricing — no broker or agent markup
• WHO GMP certified — accepted by TGA
• NABL-accredited QC — batch-specific COA from certified analysts
• TGA-ready documentation — COA, MSDS, COPP, DMF support, COO
• Dedicated export team — experienced in Australia import compliance
• Fast delivery — air freight to Australia in 3-7 days

Manufacturing Compliance for Australia Market

Our Atorvastatin Calcium API manufacturing complies with TGA (Therapeutic Goods Administration) requirements. TGA API import permit, TGA-recognised GMP certificate or overseas GMP clearance (OGC), Australian sponsor required. We provide all documentation needed for TGA import clearance, including DMF filing support.

Quality Control — Atorvastatin Calcium API

• HPLC purity testing — 98.0% minimum
• Impurity profiling per USP/BP pharmacopeial specification
• Residual solvents — ICH Q3C compliant
• Heavy metals — ICH Q3D compliant
• Stability testing — ICH Q1A compliant
• Microbial testing where applicable

To qualify Aarise Pharmaceuticals as your Atorvastatin Calcium API manufacturer for Australia, contact us at +91 9899783330. We provide GMP certificates, facility information, audit-ready documentation, and free samples within 24 hours of request.

Frequently Asked Questions

Which is the best Atorvastatin Calcium API manufacturer for Australia?

Aarise Pharmaceuticals is a WHO GMP certified Atorvastatin Calcium API manufacturer in Haridwar, India, supplying 98.0% USP/BP grade Atorvastatin Calcium (CAS 134523-03-8) to buyers in Australia with full TGA-compliant documentation. We are a direct manufacturer with NABL-accredited QC — no intermediaries.

Are Indian Atorvastatin Calcium API manufacturers TGA approved?

WHO GMP certified Indian manufacturers like Aarise Pharmaceuticals are recognised by TGA for API imports. TGA API import permit, TGA-recognised GMP certificate or overseas GMP clearance (OGC), Australian sponsor required. We provide all required documentation for smooth TGA import clearance.

How do I verify a Atorvastatin Calcium API manufacturer in India?

Verify a Atorvastatin Calcium API manufacturer by: 1) Checking their WHO GMP certificate (current, from Central Drugs Standard Control Organisation India). 2) Requesting a facility audit or inspection report. 3) Verifying NABL accreditation for QC laboratory. 4) Checking COA against pharmacopeial specifications (USP/BP). Aarise Pharmaceuticals provides all verification documents on request.

What is the manufacturing capacity for Atorvastatin Calcium API at Aarise?

Aarise Pharmaceuticals has dedicated manufacturing capacity for Atorvastatin Calcium API at our Haridwar facility. We can supply from 100g sample quantities to multi-tonne commercial batches. Lead time is 7-10 days for standard orders. Contact us for capacity confirmation for large-volume requirements.

Can I visit the Atorvastatin Calcium API manufacturing facility before ordering?

Yes. Aarise Pharmaceuticals welcomes facility audits and pre-qualification visits at our Haridwar, Uttarakhand facility. We can also provide an audit-ready documentation pack (GMP certificate, facility layout, QC SOP list, batch records) for remote quality assessment. Contact us at +91 9899783330 to schedule a visit.