Spironolactone Tablets 25mg

Summary:

API as well defined in ICH Q7A: Any substance or mixture of substances intended for use in the manufacture of a pharmaceuticalproduct and which, when used in a pharmaceutical product, becomes an active ingredient of the drug. This substance has a pharmacological activity or other direct effect in the diagnosis, treatment, symptom relief, management or prevention of disease, or can affect the function or structure of the organism.

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diagnosis symptom

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Details

API as well defined in ICH Q7A: Any substance or mixture of substances intended for use in the manufacture of a pharmaceuticalproduct and which, when used in a pharmaceutical product, becomes an active ingredient of the drug. This substance has a pharmacological activity or other direct effect in the diagnosis, treatment, symptom relief, management or prevention of disease, or can affect the function or structure of the organism.

The active ingredient in a pharmaceutical preparation. Raw materials are only processed into pharmaceutical preparations before they become available for clinical use.

APIs are divided into two categories according to their origin: chemically synthesised drugs and natural chemical drugs.

Chemical synthetics can be divided into inorganic and organic synthetics. Inorganic synthetic drugs are inorganic compounds (individually elemental), such as aluminium hydroxide and magnesium trisilicate used to treat stomach and duodenal ulcers; organic synthetic drugs are mainly drugs made from basic organic chemical raw materials, through a series of organic chemical reactions (such as aspirin, chloramphenicol, caffeine, etc.).

Natural chemical drugs can also be divided into two categories: biochemical drugs and phytochemical drugs, according to their origin. Antibiotics are generally produced by microbial fermentation and belong to the biochemical category. In recent years, a variety of semi-synthetic antibiotics have emerged, which are a combination of biosynthesis and chemical synthesis. Among the raw materials, organic synthesis of the varieties of drugs, production and output value of a large proportion, is the main pillar of the chemical pharmaceutical industry. The quality of the API determines the quality of the preparation, so its quality standards are very strict, the world for its widely used API have developed a strict national pharmacopoeia standards and quality control methods.

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Product name dapuling
Common name Spironolactone Tablets
Specification

25mg

Package 100tablets/bottle
Approval Number

State Medicine Standard H20213667

Indications And Usage • The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1) 
• Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2) 
• The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3).
 • Treatment of primary hyperaldosternism for: (1.4). Short-term preoperative treatment ; Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia
Merchants Tel

13738589090 Manager Wang

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