Your Professional Active Pharmaceutical Ingredients Supplier in China!
Xi'an Prius biological Engineering Co.Ltd is a high-tech export-oriented enterprise which is the combination of research, development, production and sales, it has been devoted to providing high quality health care raw material, cosmetic raw material, herbal extract and food additives.
- Quality Raw Material: To ensure the product quality, we have our own raw material planting base, located deep in the qinling mountains, which provides us with pure natural plant raw materials without pollution and pesticide residues. This helps us ensure supply security and ensure high-quality raw material quality in the long term.
- Advance Equipment: We have set up a state-of-the-art Analytical Laboratory to carry out various types of analysis as well as R&D work related to Herbal products. It is equipped with the latest high-performance instruments such as HPLC, UV visible spectrophotometer and Gas chromatography (GC) to keep control on solvent residuals to meet customer’s satisfactions.
- Complete Qualifications:We are an ISO9001, GMP, FDA, HALAL, KOSHER and food production license certified company, can process min 3000 MT of raw herbs per year with finishing the product in clean rooms under class 1,00,000 to deliver quality products.
- Professional Technical Team: We employs a professional staff of natural product chemists, pharmacognosists, microbiologists and herbalists. Whether you are looking for health care raw material, cosmetic raw material, herbal extract and food additives, we can provide you with high-quality one-stop product services.
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![4,4'-Dimethoxychalcone]()
4,4'-DimethoxychalconeCAS:2373-89-9view more
Purity (GC):98%
Formula:C17H16O3
MW:268.32
MP:100.6-102.2°C
Purity: >99%
In Stock
Appearance:Light yellow shining powder... -
![Albendazole Powder]()
Albendazole PowderPurity:99.5%view more
CAS:54965-21-8
Molecular formula: C₁₂H₁₅N₃O₂S
Molecular weight: 265.33 -
![Sinomenine Powder]()
Sinomenine PowderSinomenine≥97%view more
CAS number: 115-53-7
Molecular formula: C19H23NO4
Molecular weight: 329.39 -
![IDRA21]()
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![Taxifolin Dihydroquercetin]()
Taxifolin DihydroquercetinCAS: 480-18-2view more
Molecular formula: C₁₅H₁₂Oₐ
Molecular weight: 304.25
OEM OEM available -
![Palmitoylethanolamide PEA]()
Palmitoylethanolamide PEACAS No.:544-31-0view more
Molecular Formula:C18H37NO2
Molecular Weight:299.49
Product customization is available.
OEM ODM Available -
![CAS 56296-78-7]()
CAS 56296-78-7CAS Number:56296-78-7view more
Assay:99%
Molecular formula: C₁ₐH₁₉ClF₃NO
Molecular weight: 345.79
OEM ODM Available
Custom Service Available -
![Anwuligan]()
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![Oxytocin]()
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![Equol]()
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![BAM15]()
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![Slu-PP-332]()
Slu-PP-332CAS No.:303760-60-3view more
Assay:≥99% (HPLC)
Molecular formula:C18H14N2O2
Molecular weight:290.32
What are Active Pharmaceutical Ingredients?
An active ingredient is any ingredient that provides biologically active or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans or animals. The similar terms active pharmaceutical ingredient (abbreviated as API) and bulk active are also used in medicine. The term active substance may be used for natural products.
Some medication products can contain more than one active ingredient. The traditional word for the active pharmaceutical agent is pharmacon or pharmakon which originally denoted a magical substance or drug. The terms active constituent or active principle are often chosen when referring to the active substance of interest in a plant (such as salicylic acid in willow bark or arecoline in areca nuts), since the word "ingredient" can be taken to connote a sense of human agency (that is, something that a person combines with other substances), whereas the natural products present in plants were not added by any human agency but rather occurred naturally ("a plant doesn't have ingredients").
How Active Pharmaceutical Ingredients are Made?
API and raw material are often confused due to the similar usage of the two terms. What is the difference? Raw material refers to chemical compounds that are used as a base to make an API. We purchase the raw materials from raw material or chemical product manufacturers both in Japan and internationally. When using the raw materials, as an API manufacturer we produce API in the large reactor in our plant. The API is not made by only one reaction from the raw materials but rather it becomes an API via several chemical compounds. The chemical compound which is in the process of becoming an API from a raw material is called an intermediate. Among the APIs we produce, there is an API which passes through over ten kinds of intermediates in a process when it changes from being a raw material into an API. After this long manufacturing process, it is purified until it reaches a very high degree of purity and finally becomes an API.
Benefits of Active Pharmaceutical Ingredient
The therapeutic action of pharmaceutical drugs is generated primarily by Activated Pharmaceutical Ingredients during their production. They provide many advantages in the medical field.
Efficacy
APIs are responsible for the therapeutic effect of a medication. They are carefully selected and tested to ensure that they have the desired effect on the patient's condition.
Safety
APIs are subjected to rigorous safety testing to ensure that they do not cause harm to the patient. They are carefully dosed and monitored to ensure that the patient receives the appropriate amount of the medication.
Quality
APIs are manufactured according to strict quality standards to ensure that they meet the required specifications for purity, potency, and identity.
Versatility
APIs can be used to treat a wide range of medical conditions, from common ailments like pain and inflammation to complex diseases like cancer and autoimmune disorders.
Innovation
APIs are constantly being researched and developed to create new medications that can treat previously untreatable conditions or improve the effectiveness of existing treatments.
Cost-effectiveness
APIs are often available in generic forms, which can be significantly cheaper than brand-name medications. This allows patients to receive effective treatment at a lower cost.
Accessibility
APIs can be manufactured in large quantities, making them readily available to patients who need them. They can be distributed worldwide to ensure that patients in all parts of the world have access to effective treatments.
What are the Common Sources of Active Pharmaceutical Ingredients?
On the basis of origin, active pharmaceutical ingredients can be divided into four main categories as follows
This group mainly includes small chemical substances, typically with a molecular weight of under 500 Daltons. The largest category of drug substances in use today are synthetic organic substances. Examples of APIs obtained via synthetic organic chemistry include paracetamol and artovastatin. With better technology, it is also now possible to synthesise peptides having up to 20 amino acid residues in the laboratory for use as drug substances. Synthetic peptides include Somatostatin, Calcitonin and Vasopressin.
From the time immemorial, humans have resorted to the nature as a source of therapeutic substances. This remains the case today. For example, many antibiotics such as erythromycin and anticancer agents like paclitaxel are isolated from nature.
Simply put, recombinant DNA technology is the process of altering gene of an organism and using the change to produce a biological molecule such as a large protein or chemical compound. In just over a period of 40 years, recombinant DNA technology has grown to become one of the main sources of new drug substances today. Many important actives such as Human Insulin, Human Albumin, Erythropoietin and Human Growth Hormone are obtained this way, as are many vaccines and monoclonal antibodies.
There are still many therapeutic substances that can only be obtained from natural sources either as whole organisms or extracts from organisms. Examples of these include blood and plasma, attenuated or live viruses used in vaccines and human immunoglobulins. The same applies to cells, tissues and organs used various in biotechnology modalities.
Types of Active Pharmaceutical Ingredients
Each type of API has its own unique properties and requires specific manufacturing and quality control processes to ensure its safety and efficacy in pharmaceutical products. There are several types of active pharmaceutical ingredients (APIs), which can be broadly classified into the following categories
Synthetic APIs
These are chemically synthesized compounds that are produced through various chemical reactions. Examples include aspirin, paracetamol, and many antibiotics.
Natural APIs
These are active ingredients that are obtained from natural sources such as plants, animals, or microorganisms. Examples include morphine, insulin, and penicillin.
Biologic APIs
These are large, complex molecules that are produced using biotechnology methods such as recombinant DNA technology, gene editing, or cell culture. Examples include monoclonal antibodies, vaccines, and gene therapies.
Highly Potent APIs
These are APIs that are used in very small quantities but have very high potency, such as certain hormones or anticancer drugs.
Radiopharmaceutical APIs
These are APIs that contain radioactive isotopes, which are used in nuclear medicine for the diagnosis or treatment of diseases such as cancer.
Combination APIs
These are APIs that combine two or more active ingredients into a single dosage form, such as combination therapies for HIV/AIDS, hypertension, or diabetes.
The Role of Active Pharmaceutical Ingredients in Drug Manufacturing
Therapeutic Effect
The primary role of an API is to provide the therapeutic effect of a drug. The API interacts with the body in a specific way to treat a disease or condition. The effectiveness of a drug depends largely on the quality and potency of its API.
Drug Formulation
APIs are combined with excipients (inactive ingredients) to create the final drug product. The excipients serve several functions, such as helping to deliver the API to the right part of the body, enhancing the absorption of the API, and improving the taste or appearance of the drug. The formulation process must be carefully controlled to ensure that the API is evenly distributed throughout the drug product.
Quality Control
Quality control is a critical aspect of drug manufacturing, and APIs are a key focus of quality control efforts. The quality of an API can affect the safety and efficacy of a drug, so it’s essential to ensure that APIs meet strict quality standards. This involves testing the API for purity, potency, and stability, and ensuring that it has been manufactured in compliance with Good Manufacturing Practices (GMP).
Regulatory Compliance
APIs are subject to stringent regulatory requirements. Regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require detailed information about the API, including its properties, how it’s synthesized, and how it’s controlled during the manufacturing process. Meeting these regulatory requirements is a crucial part of drug manufacturing.
Manufacture of Active Pharmaceutical Ingredients
The manufacture of active pharmaceutical ingredients (APIs) is a complex process. It involves many steps, including
Synthesis
The API is synthesized from raw materials using chemical reactions. The synthesis process is carefully controlled to ensure the purity and quality of the API.
Purification
The API is purified to remove any impurities. This is typically done using a variety of techniques. This includes crystallization, filtration, and chromatography.
Drying
The API is dried to remove any moisture. This is important to prevent the API from degrading.
Packaging
The API is packed in a way that protects it from moisture, light, and other contaminants.
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Our company is a young team composed of people born in the 1990s. The working atmosphere is relaxed and harmonious, and colleagues are united and friendly. We look forward to your cooperation with us to realize our dreams together!
Common Problem of Active Pharmaceutical Ingredients
Q: What are APIs?
Q: Why regulate active ingredients?
Q: What is an API in Pharmaceuticals?
Q: How do APIs work?
Q: How is API quality ensured?
Q: What is a Nonproprietary Name in API?
Q: How are active pharmaceutical ingredients regulated?
Q: What is an Active Pharmaceutical Ingredient (API) in pharma?
Q: Why are APIs important?
Q: How are APIs produced?
Q: What is the difference between an API and Excipient?
Q: What are excipients in pharmaceuticals?
Q: What is API in pharmaceuticals?
Q: What is an active ingredient in a pharmaceutical?
Q: What do active ingredients mean?
Q: What is active pharmaceutical ingredient process?
Q: What is pharmaceutical active ingredient formulation?
Q: What is the difference between an ingredient and an active ingredient?
Q: What is the difference between drugs and API?
Q: What is API in pharma?
Q: What is the difference between active pharmaceutical ingredient and formulation?
As one of leading active pharmaceutical ingredients manufacturers and suppliers in China, we warmly welcome you to buy high quality active pharmaceutical ingredients at cheap price from our factory. Good wholesale and customized service are available for bulk products in stock.
