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Looking for 1491917-83-9 / Sacituzumab Govitecan API manufacturers, exporters & distributors?

Sacituzumab Govitecan manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Sacituzumab Govitecan API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sacituzumab Govitecan manufacturer or Sacituzumab Govitecan supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sacituzumab Govitecan manufacturer or Sacituzumab Govitecan supplier.

PharmaCompass also assists you with knowing the Sacituzumab Govitecan API Price utilized in the formulation of products. Sacituzumab Govitecan API Price is not always fixed or binding as the Sacituzumab Govitecan Price is obtained through a variety of data sources. The Sacituzumab Govitecan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Sacituzumab Govitecan

Synonyms

Sacituzumab govitecan [usan], 1491917-83-9, Hrs7-sn38, Unii-m9byu8xdq6, Hrs 7sn38, Immu 132

Cas Number

1491917-83-9

Unique Ingredient Identifier (UNII)

DA64T2C2IO

About Sacituzumab Govitecan

Sacituzumab Govitecan is an antibody drug conjugate containing the humanized monoclonal antibody, hRS7, against tumor-associated calcium signal transducer 2 (TACSTD2 or TROP2) and linked to the active metabolite of irinotecan, 7-ethyl-10-hydroxycamptothecin (SN-38), with potential antineoplastic activity. The antibody moiety of sacituzumab govitecan selectively binds to TROP2. After internalization and proteolytic cleavage, SN-38 selectively stabilizes topoisomerase I-DNA covalent complexes, resulting in DNA breaks that inhibit DNA replication and trigger apoptosis. TROP2, also known as epithelial glycoprotein-1 (EGP-1), is a transmembrane calcium signal transducer that is overexpressed by a variety of human epithelial carcinomas; this antigen is involved in the regulation of cell-cell adhesion and its expression is associated with increased cancer growth, aggressiveness and metastasis.

Sacituzumab Govitecan Manufacturers

A Sacituzumab Govitecan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sacituzumab Govitecan, including repackagers and relabelers. The FDA regulates Sacituzumab Govitecan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sacituzumab Govitecan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Sacituzumab Govitecan Suppliers

A Sacituzumab Govitecan supplier is an individual or a company that provides Sacituzumab Govitecan active pharmaceutical ingredient (API) or Sacituzumab Govitecan finished formulations upon request. The Sacituzumab Govitecan suppliers may include Sacituzumab Govitecan API manufacturers, exporters, distributors and traders.

Sacituzumab Govitecan NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Sacituzumab Govitecan as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Sacituzumab Govitecan API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Sacituzumab Govitecan as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Sacituzumab Govitecan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sacituzumab Govitecan NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Sacituzumab Govitecan suppliers with NDC on PharmaCompass.

Sacituzumab Govitecan GMP

Sacituzumab Govitecan Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Sacituzumab Govitecan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Sacituzumab Govitecan GMP manufacturer or Sacituzumab Govitecan GMP API supplier for your needs.

Sacituzumab Govitecan CoA

A Sacituzumab Govitecan CoA (Certificate of Analysis) is a formal document that attests to Sacituzumab Govitecan's compliance with Sacituzumab Govitecan specifications and serves as a tool for batch-level quality control.

Sacituzumab Govitecan CoA mostly includes findings from lab analyses of a specific batch. For each Sacituzumab Govitecan CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Sacituzumab Govitecan may be tested according to a variety of international standards, such as European Pharmacopoeia (Sacituzumab Govitecan EP), Sacituzumab Govitecan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sacituzumab Govitecan USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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