Human APIs
In healthcare, Human API usually refers to a data platform that connects medical information across different sources.
Why Choose Us
Production market
Henan Medscience's products are at the forefront of the domestic market. At the same time, the company's products are regularly exported to Europe, North America, South America, the Middle East and Asia, winning unanimous praise from domestic and foreign customers.
Customized service
In addition to existing products, we also provide customized products and new product R&D services according to customer needs.
Our R&D
Henan Medscience insists on driving high-level development with technological innovation, continuously increasing R&D investment, and establishing a R&D innovation system around human API and intermediate business.
An active pharmaceutical ingredient (API) is the component of an over-the-counter (OTC) or prescription medication that produces its intended health effects. If a prescription drug has a generic, its name is the same as its API. Combination therapies have more than one active ingredient, each of which may act differently or treat different symptoms.
Human APIs and Excipient Examples
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Raw Materials |
Examples |
API/ Excipient |
|
Organic Substances(Synthetic) |
Ibuprofen |
API |
|
Mixture Of organic Substance |
Polyethylene glycol, Soya Oil |
Excipients |
|
Mixture Of Inorganic Substance |
Bentonite |
Excipient |
|
Gases & Liquids |
Oxygen, Water |
Excipients |
|
Radio Active Substance |
Technetium |
API |
|
Biological Macromolecules |
Insulin |
API |
|
Products of Human and Animal Origin |
Human Plasma |
Excipient |
|
Plant Materials |
Herbal Drugs |
API |
APIs are broadly categorised into two types – synthetic and natural. Synthetic APIs are further classified into innovative and generic synthetic APIs, based on the type of synthesis used.
Synthetic chemical APIs, also known as small molecules, constitute a large part of the pharmaceutical market, with many small molecule drugs commercially available in the market.
Natural APIs are used in making biologics, which are increasingly becoming the top-selling drugs in the market. Despite the growing demand, biologics are currently significantly fewer in number compared to small molecule drugs.
Based on the solubility, APIs are categorised into insoluble and soluble drugs.
The term "drug substance" refers to the pure, active ingredient in its raw form before it undergoes formulation into a final dosage form. In contrast, an API, or active pharmaceutical ingredient, refers to the same active ingredient but within the context of a formulated drug product, encapsulated or combined with other components such as excipients, binders, and coatings.
Application of Human APIs
A substance used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the cure, diagnosis, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in humans.
Manufacturing Process of Human APIs
Raw material selection: The initial stage involves the meticulous choice of raw materials, taking into account their quality, purity, and suitability for the desired chemical synthesis.
Chemical reactions: Specialised chemical reactions are conducted with the purpose of converting the chosen raw materials into the appropriate active pharmaceutical ingredient (api). The aforementioned reactions are carefully regulated in order to guarantee the precise development of the desired molecular configuration.
Purification: Purification involves subjecting the initial product derived from chemical reactions to a series of processes, namely crystallisation, filtering, and chromatography, with the aim of isolating the active pharmaceutical ingredient (api) and eliminating any impurities present.
Fermentation: Microbial fermentation procedures employing certain microorganisms are utilised for the production of certain active pharmaceutical ingredients (apis). Nutrient-rich conditions are established with the purpose of promoting the growth and metabolic processes of these microorganisms, ultimately leading to the synthesis of the required (api) active pharmaceutical ingredient.
Isolation and refinement: Following the process of synthesis or fermentation, the active pharmaceutical ingredient (api) undergoes a procedure of isolation and subsequent refinement in order to get the desired level of purity and quality.
Formulation and finalization: Formulation and finalisation involve the incorporation of suitable excipients into the separated api, resulting in the production of the ultimate dosage forms. These forms are subsequently prepared for packaging and distribution to pharmaceutical businesses, where additional processing takes place.
Quality assurance and control measures are implemented throughout the API manufacturing process to maintain stringent quality standards and meet regulatory requirements.
This involves establishing robust quality management systems, conducting risk assessments, and implementing preventive measures to mitigate potential quality deviations.
Assays provide critical data and insights into the quality attributes of raw materials, intermediates, and finished products. These assays involve a variety of analytical techniques, including chromatography, spectroscopy, and titration, to quantify the concentration of active ingredients, assess purity levels, and detect impurities or contaminants.
Customizable Human APIs
The utilisation of APIs allows we to engage in the design and development of drugs that possess the ability to be customised and modified in order to effectively address the unique requirements of individual patients. Healthcare practitioners have the ability to optimise treatment outcomes by modifying the concentration and combination of active pharmaceutical ingredients, thereby tailoring treatment programmes to suit specific patients.
Packing and Shipping of Human APIs
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packing |
Box/bag |
|
Shipping |
Shipped by road, sea, rail |
FAQ
We're professional human apis manufacturers and suppliers in China, specialized in providing high quality human and veterinary APIs and intermediates. We warmly welcome you to buy high-grade human apis from our factory.
