Metformin HCl API Manufacturer for USA — WHO GMP Certified India

Aarise Pharmaceuticals is a WHO GMP certified Metformin HCl API manufacturer in Haridwar, India, supplying USP/BP/IP grade Metformin HCl (CAS 1115-70-4) to pharmaceutical companies in USA. We are a direct manufacturer — not a trader — with a NABL-accredited QC laboratory and full FDA-ready documentation.

About Our Metformin HCl 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/IP pharmacopeial grade at 99.0% purity
• Capacity: 100g samples to multi-tonne commercial batches
• Lead Time: 7-10 days standard

Why Choose Aarise as Your Metformin HCl API Manufacturer for USA?

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

Manufacturing Compliance for USA Market

Our Metformin HCl API manufacturing complies with FDA (Food and Drug Administration) requirements. FDA Drug Master File (Type II DMF) submission, facility registration with FDA, prior notice for imports, US agent appointment. We provide all documentation needed for FDA import clearance, including DMF filing support.

Quality Control — Metformin HCl API

• HPLC purity testing — 99.0% minimum
• Impurity profiling per USP/BP/IP 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 Metformin HCl API manufacturer for USA, 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 Metformin HCl API manufacturer for USA?

Aarise Pharmaceuticals is a WHO GMP certified Metformin HCl API manufacturer in Haridwar, India, supplying 99.0% USP/BP/IP grade Metformin HCl (CAS 1115-70-4) to buyers in USA with full FDA-compliant documentation. We are a direct manufacturer with NABL-accredited QC — no intermediaries.

Are Indian Metformin HCl API manufacturers FDA approved?

WHO GMP certified Indian manufacturers like Aarise Pharmaceuticals are recognised by FDA for API imports. FDA Drug Master File (Type II DMF) submission, facility registration with FDA, prior notice for imports, US agent appointment. We provide all required documentation for smooth FDA import clearance.

How do I verify a Metformin HCl API manufacturer in India?

Verify a Metformin HCl 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 Metformin HCl API at Aarise?

Aarise Pharmaceuticals has dedicated manufacturing capacity for Metformin HCl 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 Metformin HCl 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.