Dihydropyridine Calcium Channel Blocker for Hypertension and Angina – High-Volume API
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Amlodipine Besylate API (CAS 111470-99-6) is an Active Pharmaceutical Ingredient used in the formulation of prescription and/or over-the-counter pharmaceutical products. Swapnroop Drugs and Pharmaceuticals manufactures and supplies Amlodipine Besylate API with pharmacopeial compliance (IP/BP/EP/USP as applicable) from our WHO-GMP certified facility in Aurangabad (MIDC Shendra), Maharashtra — one of India's premier pharmaceutical manufacturing zones with robust regulatory infrastructure.
Pharmaceutical formulation companies sourcing Amlodipine Besylate API require consistent polymorphic or salt form characterisation, batch-to-batch HPLC purity ≥98% (or per specific pharmacopeial monograph), validated residual solvent control per ICH Q3C, and full impurity profiling against pharmacopeial limits. Our quality control laboratory performs complete pharmacopeial testing with USP/EP/IP validated analytical methods before every batch release.
Swapnroop's Amlodipine Besylate API supply is backed by WHO-GMP certified manufacturing, a qualified vendor documentation package (CoA, MSDS, Certificate of Origin, stability data), and dedicated technical support for domestic formulation companies and international export customers. We maintain inventory for rapid order fulfilment across 25+ countries served from our Aurangabad facility.
Amlodipine Besylate API is supplied in double-polyethylene-lined HDPE drums or fiber drums (25 kg net) with desiccant and nitrogen head-space. Smaller quantities (1 kg, 5 kg) in sealed HDPE jars for R&D programs. All packaging labelled with batch, grade, and pharmacopeial standard.
Get Bulk QuoteThe CAS number for Amlodipine Besylate is 111470-99-6. It is the benzenesulfonate salt form of Amlodipine, the preferred commercial salt for tablet manufacture.
Amlodipine Besylate offers superior aqueous solubility, lower hygroscopicity than the maleate salt, better palatability in tablet formulations, and wider regulatory market acceptance in USFDA and EMA approved products.
The primary quality concerns are dehydro-Amlodipine (an oxidative degradation product, limit <0.1%) and R-enantiomeric impurity (chiral purity, limit <0.5%). Both are controlled and certified on every Swapnroop batch.
MOQ is 25 kg with competitive pricing for 100 kg, 500 kg, and full-drum orders. We supply to major Indian formulation manufacturers and export customers with consistent monthly availability.
Yes. We supply Amlodipine Besylate for all FDC development programs including Amlodipine + Atorvastatin, Amlodipine + Olmesartan, Amlodipine + Valsartan, and other antihypertensive combinations.
Swapnroop Drugs and Pharmaceuticals is a trusted Amlodipine Besylate API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Amlodipine Besylate API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Amlodipine Besylate API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Amlodipine Besylate API pricing, samples, and sourcing support.