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Valsartan is a selective angiotensin II type 1 (AT1) receptor antagonist (ARB) indicated for the treatment of hypertension, heart failure, and renal protection in diabetic nephropathy. It lowers blood pressure by blocking the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation and reduced cardiac workload. Our Valsartan API is manufactured under WHO-GMP / cGMP conditions and is suitable for tablet and capsule formulations.
Therapeutic Uses
- Hypertension (first-line or combination therapy)
- Heart failure (to reduce morbidity and mortality)
- Renal protection in diabetic nephropathy (to reduce progression of kidney damage)
- Fixed-dose combinations with HCTZ or amlodipine are commonly formulated.
Mechanism of Action
Valsartan selectively blocks AT1 receptors, preventing angiotensin II-mediated vasoconstriction and aldosterone release. The result is systemic vasodilation, decreased sodium and water retention, and lowered blood pressure with minimal effect on bradykinin (so lower cough incidence vs ACE inhibitors).
Pharmacological & Chemical Information
- IUPAC / Chemical Name (short): N-(1-Oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-valine (commonly referenced form).
- Molecular Formula: C24H29N5O3.
- Molecular Weight: 435.52 g·mol⁻¹.
- CAS Number: 137862-53-4.
- Therapeutic Class: Angiotensin II Receptor Blocker (ARB).
Physical & Chemical Properties (Typical)
| Property | Typical |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Practically insoluble in water; soluble in methanol, ethanol |
| Melting Point | ~213°C – 217°C (manufacturer dependent) |
| Storage | Store in a cool, dry place; protect from light and moisture |
Technical Specifications (Example / Export Grade)
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, HPLC — Positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.3% (individual) |
| Bulk Density | 0.35 – 0.55 g/mL |
(Analytical methods, COA and release specifications provided per batch.)
Applications
- Primary raw material for oral solid dosage forms (tablets, capsules) for hypertension and heart-failure indications
- Fixed-dose combinations: valsartan/hydrochlorothiazide, valsartan/amlodipine, valsartan/sacubitril (for manufacturer of combination products)
- Suitable for both generic and branded pharmaceutical production.
Advantages of Bluepill Express Valsartan
- Manufactured in WHO-GMP / cGMP certified facilities
- High assay purity and low impurity profile for stable formulations
- Consistent particle size and flow for reliable tableting/compression
- Full regulatory documentation (COA, MSDS, TDS, stability data) and DMF support on request
- Export-ready packaging and labeling for regulated and semi-regulated markets.
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (ICH guidelines)
- Regulatory Dossier / DMF (available on request)
Packaging & Export Details
- Available Packs: 1 kg / 5 kg / 10 kg / 25 kg HDPE drums with double poly liners (custom packaging available)
- Labeling: Product name, batch number, MFG/EXP, net weight, storage instructions
- Shelf Life: 36–60 months depending on storage and regulatory requirements
- Export Markets: Worldwide (EU, UK, USA — subject to regulatory approvals for finished products)
