Trastuzumab API Manufacturers

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Produced in:

United States

Established in: 2005

MOQ: -

Employees: 200+

Portfolio of over 2,000 APIs

Precise quality control

End-to-end global regulatory support

  • CoA

  • GMP

  • CEP

  • FDA

  • DMF

  • + 0

All certificates

  • CoA

  • DMF

  • GMP

  • WHO-GMP

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Produced in:

China

Established in: 2019

MOQ: 1 g

Employees: 10+

Focused on pharmaceutical industry

Reasonable price for the customers

Full service from R&D stage to commercial stage

  • CoA

  • GMP

  • CEP

  • FDA

  • DMF

  • + 0

All certificates

  • CoA

  • GMP

  • DMF

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Located in:

China

Produced in:

China

Established in: 1987

MOQ: 100 g

Employees: 50+

Passed ISO9001:2015 and SGS audit

Provide one-stop CDMO service from R&D to production

Specialized in APIs & Pharmaceutical Intermediates for 37 years

  • CoA

  • GMP

  • CEP

  • FDA

  • DMF

  • + 0

All certificates

  • CoA

  • ISO9001

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Located in:

Austria

Producer

Produced in:

Austria

MOQ: -

  • CoA

  • GMP

  • CEP

  • FDA

  • DMF

  • + 0

All certificates

  • GMP

  • CoA

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Replies slower than most

Located in:

South Korea

Producer

Produced in:

South Korea

MOQ: -

  • CoA

  • GMP

  • CEP

  • FDA

  • DMF

  • + 0

All certificates

  • JDMF

  • CoA

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Replies slower than most

Producer

Produced in:

India

Established in: 1995

MOQ: -

Employees: 10000

Fermentation technology Experts

Partnerships with 1200 pharma companies in 100+ countries

US FDA, EMA, COFEPRIES, ANVISA, PMDA accreditations

  • CoA

  • GMP

  • CEP

  • FDA

  • DMF

  • + 0

All certificates

  • GMP

  • CoA

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Looking for Trastuzumab API 180288-69-1?

Description:
Here you will find a list of producers, manufacturers and distributors of Trastuzumab. You can filter on certificates such as GMP, FDA, CEP, Written Confirmation and more. Send inquiries for free and get in direct contact with the supplier of your choice.
API | Excipient name:
Trastuzumab 
Synonyms:
 
Cas Number:
180288-69-1 
DrugBank number:
DB00072 
Unique Ingredient Identifier:
P188ANX8CK

About Trastuzumab

So, what does it do? Produced in CHO cell cultures, trastuzumab is a recombinant IgG1 kappa, humanized monoclonal antibody 6 that selectively binds with high affinity in a cell-based assay (Kd = 5 nM) to the extracellular domain of the human epidermal growth factor receptor protein (HER2). It is used as a treatment of human epidermal growth factor receptor (HER)-2+ metastatic breast cancer, where there is a proven amplification of the HER-2 oncogene or over-expression of the HER-2 protein in tumours. It is suggested that the overexpression or gene amplification of HER2 has been found in about 20–30% of breast cancers and elevated activation of HER2 triggers multiple downstream pathways leading to abnormal proliferation of cancer cells Trastuzumab binds to HER2 and suppresses cancer cells growth, proliferation, and survival directly and indirectly In December 2017, FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). It displays biosimilar properties as Herceptin according to clinical data.

While Ogivri is the first biosimilar approved in the USA for the treatment of breast cancer or stomach cancer, it is the second biosimilar approved in the USA for the treatment of cancer. Herzuma (trastuzumab-pkrb) is a biosimilar drug approved in December 2018 for the treatment of HER2-overexpressing breast cancer. KANJINTI (trastuzumab-anns) is another biosimilar approved by the FDA in June 2019.

You can ask the supplier about all relevant certificates for the product such as CoA, Safety Data Sheet and DMF.

Trastuzumab is a type of Monoclonal antibodies


Monoclonal antibodies are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the field of biopharmaceuticals. These antibodies are produced by cloning a single type of immune cell to create identical copies, allowing for targeted treatment of various diseases.

Monoclonal antibodies have gained significant attention in recent years due to their potential in treating a wide range of conditions, including cancer, autoimmune disorders, and infectious diseases. Their specificity and ability to bind to specific antigens make them highly effective therapeutic agents.

These pharmaceutical APIs are typically developed using hybridoma technology or recombinant DNA technology. Hybridoma technology involves fusing antibody-producing cells with immortalized cells to create hybrid cells that produce large quantities of monoclonal antibodies. Recombinant DNA technology, on the other hand, utilizes genetically engineered organisms such as bacteria or mammalian cells to produce monoclonal antibodies.

The production of monoclonal antibodies requires stringent quality control measures to ensure purity, potency, and safety. Extensive characterization and validation tests are conducted to assess their binding specificity, stability, and absence of contaminants.

Monoclonal antibodies have revolutionized the pharmaceutical industry, offering personalized treatment options and improving patient outcomes. They provide targeted therapy with fewer side effects compared to traditional treatments. The development and use of monoclonal antibodies continue to expand, with ongoing research aiming to enhance their effectiveness and broaden their applications.

In summary, monoclonal antibodies represent a significant advancement in the field of biopharmaceuticals, offering targeted therapy for a variety of diseases. Their precise mechanism of action and potential for personalized treatment make them a promising class of pharmaceutical APIs.


Trastuzumab (Monoclonal antibodies), classified under Immunomodulators


Immunomodulators, a category of pharmaceutical active pharmaceutical ingredients (APIs), are substances that help regulate and modify the immune response of an individual. These compounds play a crucial role in treating various immune-related disorders and diseases. Immunomodulators work by either enhancing or suppressing the immune system, depending on the specific condition being treated.

Immunomodulators are used in the treatment of autoimmune disorders, such as rheumatoid arthritis, multiple sclerosis, and psoriasis. By suppressing the immune system, these APIs help reduce the overactive immune response associated with these conditions, thereby alleviating symptoms and preventing further damage to the body's tissues.

On the other hand, immunomodulators are also employed to boost the immune system in cases of immunodeficiency disorders. These APIs stimulate the immune response, enabling the body to better fight off infections and diseases. Additionally, immunomodulators are utilized in the prevention and treatment of organ transplant rejection, where they help modulate the immune system to accept the transplanted organ.

The development and production of immunomodulators require rigorous testing and quality control to ensure their safety and efficacy. Pharmaceutical companies carefully formulate these APIs into various dosage forms, including tablets, capsules, injections, and topical preparations, to cater to different patient needs.

In summary, immunomodulators form a vital category of pharmaceutical APIs that regulate and modify the immune system. With their ability to modulate immune responses, these compounds contribute significantly to the management and treatment of various immune-related disorders and diseases, improving the quality of life for many patients.



Trastuzumab manufacturers | traders | suppliers

We have 6 companies offering Trastuzumab produced in 5 different countries.

Get in contact with the supplier of your choice:

  • LGM Pharma from United States, product country of origin United States
  • Apino Pharma Co., Ltd. from China, product country of origin China
  • Sinoway industrial Co.,Ltd from China, product country of origin China
  • Sandoz from Austria, product country of origin Austria
  • Celltrion from South Korea, product country of origin South Korea
  • Biocon from India, product country of origin India

Let the supplier know whether you are looking for a product with a specific monograph such as EP (Ph. Eur.), USP, JP, BP or another quality. Or, whether you are looking for hydrochloride (HCl), anhydricum, base, micronisatum or a specific purity.

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