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Valsartan
API

To guarantee the highest purity and efficacy, we adhere to strict global standards

HUMAN API

Valsartan

Valsartan is a core Active Pharmaceutical Ingredient (API) belonging to the class of Angiotensin II Receptor Blockers (ARBs). It is widely and effectively used in the management of hypertension (high blood pressure) and heart failure. It works by blocking the effects of Angiotensin II, leading to vasodilation and improved blood flow. We supply Valsartan with high quality and optimal purity to support the production of various tablet formulations, including complex fixed-dose combinations..

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).
A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.
A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.
Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).
Therapeutic Class:
Angiotensin II Receptor Blocker (ARB).
Mechanism of Action:
Selectively and competitively prevents Angiotensin II from binding to the $AT_1$ receptors in various tissues, thereby inhibiting the vasoconstricting and blood-pressure raising effects of Angiotensin II..
Clinical Application:
Treatment of Hypertension, Heart Failure, and post-Myocardial Infarction (heart attack) treatment.
Competitive Advantage:
A crucial cardiovascular API with a favorable safety profile, known for not inducing the dry cough typically associated with ACE inhibitors.
Oral Tablets

Immediate-release tablets and capsules.

API powder offers uniform flow and compressibility characteristics, essential for high-speed tableting and encapsulation processes.

Fixed-Dose Combinations (FDCs)

Tablets combining Valsartan with diuretics (e.g., Hydrochlorothiazide) or Calcium Channel Blockers.

Excellent compatibility with a wide range of other APIs for complex, single-pill combination formulations.

Packaging Protocol

Requires strict procedures to mitigate Nitrosamine impurities.

We ensure stringent control over the synthesis and processing route to guarantee volatile impurities meet strict global regulatory standards.

Regulatory Compliance

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).

Certificate of Analysis (CoA)

A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.

Drug Master File (DMF)

A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.

Manufacturing Operations

Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).

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