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Amlodipine Besylate API Manufacturer for UK | WHO GMP Certified India
Amlodipine Besylate API Manufacturer for UK — WHO GMP Certified India
Aarise Pharmaceuticals is a WHO GMP certified Amlodipine Besylate API manufacturer in Haridwar, India, supplying USP/BP grade Amlodipine Besylate (CAS 111470-99-6) to pharmaceutical companies in UK. We are a direct manufacturer — not a trader — with a NABL-accredited QC laboratory and full MHRA-ready documentation.
About Our Amlodipine Besylate 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 99.0% purity
- Capacity: 100g samples to multi-tonne commercial batches
- Lead Time: 7-10 days standard
Why Choose Aarise as Your Amlodipine Besylate API Manufacturer for UK?
- Direct manufacturer pricing — no broker or agent markup
- WHO GMP certified — accepted by MHRA
- NABL-accredited QC — batch-specific COA from certified analysts
- MHRA-ready documentation — COA, MSDS, COPP, DMF support, COO
- Dedicated export team — experienced in UK import compliance
- Fast delivery — air freight to UK in 3-7 days
Manufacturing Compliance for UK Market
Our Amlodipine Besylate API manufacturing complies with MHRA (Medicines and Healthcare products Regulatory Agency) requirements. MHRA API registration, UK GMP certificate (post-Brexit separate from EU GMP), UK Responsible Person (RP) required for import. We provide all documentation needed for MHRA import clearance, including DMF filing support.
Quality Control — Amlodipine Besylate API
- HPLC purity testing — 99.0% 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 Amlodipine Besylate API manufacturer for UK, 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 Amlodipine Besylate API manufacturer for UK?
Aarise Pharmaceuticals is a WHO GMP certified Amlodipine Besylate API manufacturer in Haridwar, India, supplying 99.0% USP/BP grade Amlodipine Besylate (CAS 111470-99-6) to buyers in UK with full MHRA-compliant documentation. We are a direct manufacturer with NABL-accredited QC — no intermediaries.
Are Indian Amlodipine Besylate API manufacturers MHRA approved?
WHO GMP certified Indian manufacturers like Aarise Pharmaceuticals are recognised by MHRA for API imports. MHRA API registration, UK GMP certificate (post-Brexit separate from EU GMP), UK Responsible Person (RP) required for import. We provide all required documentation for smooth MHRA import clearance.
How do I verify a Amlodipine Besylate API manufacturer in India?
Verify a Amlodipine Besylate 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 Amlodipine Besylate API at Aarise?
Aarise Pharmaceuticals has dedicated manufacturing capacity for Amlodipine Besylate 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 Amlodipine Besylate 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.