Your Professional Active Pharmaceutical Ingredients Manufacturer!
Located in Xiasha Economic Development Park of Hangzhou city (capital of Zhejiang province in the southeast coastal region of China), Hangzhou Dingyan Chem Co.,Ltd is a modern private enterprise; The company was founded in 2013 and has more than ten years of experience in this industry. we are mainly engaged in the development, trade and independent import and export business of hi-tech products such as pharmaceutical materials (APIs), pharmaceutical intermediates, fine chemicals and biochemical reagents, etc.
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Why Choose Us
Rich Experience
The company was founded in 2013 and has more than ten years of experience in this industry.
High Quality
Our products are manufactured or executed to very high standards, using the finest materials and manufacturing processes.
Research And Development
Insisting on the development path of "scientific and technological innovation" since our foundation, dingyan-chemical has laid great stresses on the research and development of scientific and technological innovation.
Production Market
Dingyan's products are well sold in more than 60 countries and regions in North America, Western Europe, Southeast Asia, Central and South America, and then established long-term and steady relations of cooperation with many pharmaceutical enterprises in Europe, USA, Greece, Germany, South Korea and India, etc.
Advantages of Active Pharmaceutical Ingredients
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.
Types of Active Pharmaceutical Ingredients
Small Molecule APIs
Small molecule APIs are organic compounds with a low molecular weight. They are chemically synthesized and account for a significant portion of the API market. These APIs are typically well-defined, stable, and have a high level of purity. Small molecule APIs are widely used in various therapeutic areas, including cardiovascular diseases, infectious diseases, oncology, and central nervous system disorders.
Biologic APIs
Biologic APIs, also known as large molecule APIs, are complex molecules derived from living organisms or manufactured through biotechnological processes. They include proteins, peptides, antibodies, and nucleic acids. Biologic APIs exhibit high specificity and are used in advanced therapies such as monoclonal antibodies, recombinant proteins, and gene therapies. They require specialized manufacturing processes and stringent quality control measures.
Synthetic APIs
Synthetic APIs are chemically synthesized compounds that are manufactured through organic synthesis. These APIs are created by assembling and modifying chemical structures using various reactions and techniques. Synthetic APIs offer advantages such as scalability, cost-effectiveness, and consistent quality. They are widely used in the pharmaceutical industry and have applications in diverse therapeutic areas.
Natural Product APIs
Natural product APIs are derived from natural sources such as plants, animals, or microorganisms. These APIs are obtained through extraction or isolation processes from natural materials. Natural product APIs have a long history of use in traditional medicine and continue to be valuable sources of therapeutic compounds. They often possess complex chemical structures and exhibit diverse pharmacological activities.
Product Specifications
|
Color |
White or yellow white |
|
Appearance |
Fine Powder |
|
Analytical Quality |
|
|
Identification |
Identical to R.S. sample |
|
Assay |
≥98.0% |
|
Sieve analysis |
100 % through 80 mesh |
|
Water(KF) |
≤1.0 % |
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Total Ash |
≤1.0 % |
|
Contaminants |
|
|
Lead (Pb) |
≤3.0 mg/kg |
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Arsenic (As) |
≤2.0 mg/kg |
|
Cadmium (Cd) |
≤1.0 mg/kg |
|
Mercury (Hg) |
≤0.1 mg/kg |
|
Solvents Residue |
Meet Eur.Ph.7.0 <5.4> |
|
Pesticides Residue |
Meet USP Requirements |
|
Microbiological |
|
|
Total Plate Count |
≤10000 cfu/g |
|
Yeast &Mold |
≤1000 cfu/g |
|
E.Coli. |
Negative |
|
Salmonella |
Negative |
Uses of Active Pharmaceutical Ingredients in the Pharmaceutical Industry
Drug Manufacturing
APIs are the foundation of pharmaceutical formulations. They are used to manufacture medicines in various forms, including tablets, capsules, syrups, and injectables. The pharmaceutical industry relies on APIs to create drugs for treating diseases such as diabetes, cardiovascular disorders, and infections.
Treatment of Diseases
APIs target specific biological pathways to treat illnesses. Different APIs are designed for different therapeutic areas, such as:
• Analgesics: APIs like ibuprofen relieve pain.
• Antidepressants: APIs like help manage mental health conditions.
• Anticancer Drugs: APIs like combat cancer cells.
By tailoring APIs to specific medical conditions, pharmaceutical companies ensure that patients receive effective treatment.
Customized Medicine Development
APIs enable the development of personalized medicine, which tailors treatments to individual patients based on their genetic makeup. This is particularly useful in oncology and rare disease treatment, where one-size-fits-all solutions may not be effective.
Research and Development (R&D)
APIs are essential for pharmaceutical research. Scientists and researchers use APIs in preclinical and clinical trials to evaluate their safety, efficacy, and dosage. APIs play a significant role in discovering and testing new drugs to address emerging health challenges like COVID-19.
Production of Generic Drugs
Generic drugs, which are cost-effective alternatives to branded medications, rely on APIs. After the patent of a branded drug expires, other manufacturers can produce generic versions using the same API. This ensures affordable healthcare access without compromising quality.
Combination Therapies
APIs are often combined to create combination drugs that treat multiple symptoms or diseases simultaneously. These therapies are widely used in conditions like hypertension, diabetes, and HIV/AIDS.
Vaccines and Biologics
APIs are crucial in the production of vaccines and biologics, which are complex medicines derived from living organisms. They stimulate the immune system to prevent or treat diseases.
The Active Pharmaceutical Ingredients Manufacturing Process
The production of APIs is a multi-step process that encompasses synthesis, purification, and formulation stages.
The manufacturing process begins with the synthesis of the active ingredient, where chemical reactions are carefully controlled to produce the desired compound. This synthesis step involves selecting appropriate starting materials, applying specific reaction conditions, and optimizing process parameters to achieve high yields and purity levels.
Following synthesis, the API undergoes purification processes, such as crystallization, distillation, or chromatography, to isolate and remove impurities, ensuring the final product meets stringent quality standards.
Once purified, the API is formulated into dosage forms, such as tablets, capsules, or injections, using excipients and other additives as necessary to enhance stability, solubility, and patient acceptability.
Storage and transportation
Our Certificates
FAQ
We're professional active pharmaceutical ingredients manufacturers and suppliers in China, specialized in providing high quality customized service. If you're going to wholesale discount pharmaceutical and chemical raw materials, welcome to get free sample from our factory.
103-90-2, 147098-20-2, 58-63-9