What is a Chemical API? Is an API a drug?

Chemically synthesized

Powders, crystals, extracts, etc., which are extracted from plants or prepared by biotechnology for medicinal purposes, but cannot be taken directly by patients.

And from this powder, crystallization,

Drugs in the extract state are processed into patient-friendly forms of administration (e.g., tablets, capsules, injections, pills, ointments, etc.), which are called dosage forms of the drug.

Specific API after processing – pharmaceutical preparation.

The term "API" is mainly relative to the preparation.

Based on raw materials obtained by chemical processing, the raw materials for the production of finished drugs, such as cefpirol sulfate for injection, are medicines, so cefpir sulfate is an API.

Chemical raw materials are raw materials that are produced using chemical methods. Including inorganic chemical products other than fertilizers, inorganic pesticides, inorganic pigments, etc., and various products mainly made of polymer materials in the organic synthesis industry. Specifically, it is divided into:

1) Basic chemical raw materials, including triacids (hydrochloric acid, sulfuric acid, nitric acid), two alkalis (soda ash, caustic soda) and various inorganic salts. They are important raw materials in various industrial sectors, in addition to being widely used in the chemical industry, mining, metallurgy, machinery, light industry and all walks of life need to use. (2) The three major organic synthetic materials (plastics, synthetic fibers and synthetic rubber) and the new three synthetic materials such as synthetic leather, synthetic paper and synthetic wood.

Shanghai Ziyi Reagent Factory has chemical raw materials s h u o

In recent years, the state has implemented preferential tariff policies for imported anti-cancer drugs and raw materials for rare diseases, reducing the tax burden on importing enterprises, encouraging pharmaceutical companies to independently develop domestic drugs for rare diseases, providing consumers with more diversified choices, and promoting the development of domestic drug industry. So how to standardize the declaration of the import of these anti-cancer and rare disease drug APIs, let's take a look.

What is an active pharmaceutical substance?

Active pharmaceutical ingredients (API), also known as active pharmaceutical ingredients, are substances prepared by chemical synthesis, plant extraction or biotechnology, but cannot be taken directly by patients, and are generally made into pharmaceutical preparations that can be used directly after adding excipients and processing.

What is the difference between an API and a common pharmaceutical formulation?

API refers to the pharmaceutical raw materials for the production of pharmaceutical preparations, which are divided into chemical APIs, biochemical APIs, and natural APIs, which are the active ingredients or active ingredients in pharmaceutical preparations, which patients cannot take directly, usually powders, crystals and extracts.

Pharmaceutical preparations are made in accordance with certain dosage form requirements for the purpose of ** or prevention, and can be finally provided to the drug object, usually tablets, capsules and injections. The API is processed into a pharmaceutical formulation that can be used for clinical application.

Interpretation of tax policies for anti-cancer and rare disease drug APIs.

In order to encourage the development of the anti-cancer and rare disease pharmaceutical industry, reduce the cost of drug use for patients, and reduce the economic burden of the people, the Ministry of Finance, the General Administration of Customs, the State Administration of Taxation and the State Medical Products Administration jointly issued the Notice of the Ministry of Finance, the General Administration of Customs, the State Administration of Taxation and the State Administration for Market Regulation on the VAT Policy for Anti-cancer Drugs (CS 2018 No. 47) and the Notice of the Ministry of Finance, the General Administration of Customs, the State Administration of Taxation and the Food and Drug Administration on the VAT Policy for Drugs for Rare Diseases (CS 2019 No. 24) (hereinafter referred to as the "Notice") ), and has successively published two batches of anti-cancer and rare disease drug API lists. In accordance with the relevant regulations, the import value-added tax will be levied at a reduced rate of 3% for the anti-cancer and rare disease drug APIs in the import list.

The term "anti-cancer and rare disease drug APIs" in the Notice refers to anti-cancer and rare disease drug APIs approved and registered by the State Drug Administration. Enterprises importing APIs in the list shall go through import customs clearance procedures with the approval documents of the State Drug Administration.

How to declare accurately?

The chemical name and molecular structure of anti-cancer and rare disease drug APIs are complex, and enterprises need to declare the generic name of the active ingredient in accordance with the API when importing the API in the list, and declare the specific use (API, laboratory reagent or other use) in the specification and model column. In order to facilitate the declaration of enterprises, the customs has split the 10-digit customs commodity code for the anti-cancer and rare disease drug APIs in the list. Illustrate.

API & Preparation: API refers to the API used in the production of various preparations, which is the active ingredient in the preparation, which is divided into chemical synthesis and natural chemistry, but patients generally cannot take it directly, and it needs to be processed into preparations before it can be taken. The term "API" is mainly relative to the preparation.

Example 1: Vitamin AD drops. The active ingredient is vitamin AD, which is an API, processed into a small gourd capsule, which is the preparation;

Example 2: Amoxicillin capsules. The active ingredient is amoxicillin, which is the API, processed into capsules, which is the preparation.

Drug Administration Law of the People's Republic of China (Drug Administration Law of the People's Republic of China (2019 Revision): The term "drugs" in this Law refers to substances used to prevent, diagnose human diseases, purposefully regulate human physiological functions, and stipulate indications or functional indications, usage, and dosage, including traditional Chinese medicine, chemical drugs, and biological products.

APIs are not drugs, but they are managed as drugs.

Chemical raw materials are the raw materials for the production of various reagents, which are relatively pure and relatively small in quantity. Chemical raw materials refer to various raw materials used in chemical industry, which may be composite raw materials, raw materials used to process chemical products, and the purity is not so high.

Chemical raw materials refer to the raw materials used in the production of various preparations, chemical synthesis, plant extraction or biotechnology preparation process.

There are many types of chemical raw materials and they are used in a wide range of applications. There are as many as 500,700,000 chemicals worldwide, more than 100,000 are in circulation**, and more than 1,000 new chemicals are introduced every year, of which 150,200 are considered carcinogenic.

1. Different definitions.

1. Chemical raw drug Youmo: refers to the raw materials used in the production of various preparations, which are the active ingredients in the preparations, and are prepared by chemical synthesis, plant extraction or biotechnology for various powders, crystals, extracts, extracts, etc., which are used for medicinal purposes, but cannot be taken directly by patients.

2. Chemical preparations: The process of processing APIs and excipients (starch, glucose, etc.) is called preparations (made into agents). After the preparation process, the API becomes a fibrillated capsule, injection, etc., which is the so-called pharmaceutical preparation.

Second, the composition is different.

1. Chemical raw drug: It is intended to be used in the manufacture of any substance or mixture of substances, and when used in medicine, it becomes an active ingredient of the drug. This substance has pharmacological activity or other direct effects in the diagnosis, alleviation, treatment or prevention of diseases, or can affect the function or structure of the body.

2. Chemical preparations: Before the stability test of pharmaceutical preparations, the content of reactants or decomposition products should be selected, but the method of determining the drug is usually selected, because the content of the decomposition product can be distinguished by reactants or decomposition products, but the method of determining the drug is usually selected.

Because the decomposition products are often complex, sometimes the decomposition products may immediately decompose again, making it difficult to accurately measure them.

Third, the regulatory requirements are different.

1. Chemical raw materials: the active ingredients of the drug. Only when APIs are processed into pharmaceutical preparations can they become medicines for clinical application.

2. Chemical preparations: medicines that can be directly used for clinical application.

Chemical APIs.

It is a variety of powders, crystals, extracts, etc., which are used as medicinal substances prepared by chemical synthesis, plant extraction or biotechnology, but patients cannot talk about taking them directly. The drug in the form of this powder, crystal, and extract is processed into a form of administration that is convenient for patients to take (such as tablets, capsules, injections, pills, ointments, etc.), and these forms of medicine are called dosage forms of drugs.

Specific API after processing – pharmaceutical preparation.

The term "API" is mainly relative to the preparation.

Mainly based on the raw materials obtained by chemical plus air dispatch, the raw materials for the production of finished drugs.

For example, cefpiro-sulfate for injection is a drug, so cefpiro-sulfate is an API.

Summary. The original chemical drug is a pure product, which does not contain excipients, and is mainly used as a raw material for the production of chemical preparations, etc., and cannot be used in clinical practice. Chemical preparations are chemical raw materials and excipients, in accordance with the national drug standards, produced for clinical prevention, **, diagnosis of human diseases pharmaceutical dosage form.

The original chemical drug is a pure product, which does not contain excipients, and is mainly used as a raw material for the production of chemical preparations, and cannot be used in clinical practice. Chemical preparations are chemical raw materials and excipients, which are produced in accordance with national drug standards and are suitable for clinical prevention, diagnosis and diagnosis of human diseases.

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Mind map of technical specifications for procurement and quality inspection of injectable ampoules.

There are no relatives here.

<> API is not a drug, it can be simply understood that the material made into the drug cannot be directly taken or used externally.

API: refers to the API used in the production of various preparations, which are the active ingredients in the preparations, and are various powders, crystals, extracts, etc. prepared by chemical synthesis, plant extraction or biotechnology for medicinal purposes, but cannot be taken directly by patients.

API refers to the raw materials used in the production of various preparations, drugs are the active ingredients in the preparations, including chemical synthesis, plant extraction or biotechnology prepared for various crop drugs, crystallization ointment, etc.

The production process of an API has its own characteristics compared to a pharmaceutical formulation, and the production of an API often involves complex chemical changes and.

The change process of raw bistone has a more complex intermediate control process, and the production process often produces by-products, so that the purification process is usually required, no.

The production equipment and operation process of the same variety are very different, and the same reaction equipment is usually used for different reactions. With the development of science and technology, automation is born.

The mechanism of response has not yet been fully understood.

The process of API is complex and diverse, some of which are very long, such as steroid hormones, and some are relatively short, such as extraction. Generally speaking, the original.

There is a refining process in the production process of raw materials, and the main purpose of the process is to remove impurities in the raw materials.

The production process of APIs is based on chemical unit reactions and unit chemical operations.

Generally speaking, in the production process of the preparation, there is little change in the chemical structure of the material, but in the production process of the API, the chemical formation of the material.

Structural changes are frequent.