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Looking for 1613313-09-9 / Rovalpituzumab Tesirine API manufacturers, exporters & distributors?

Rovalpituzumab Tesirine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Rovalpituzumab Tesirine 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 Rovalpituzumab Tesirine manufacturer or Rovalpituzumab Tesirine supplier for your needs.

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

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

API | Excipient name

Rovalpituzumab Tesirine

Synonyms

Rova-t, Rovalpituzumab-tesirin, Unii-p256hb60ff, Rovalpituzumab tesirine [inn], P256hb60ff, Rovalpituzumab tesirine [who-dd]

Cas Number

1613313-09-9

About Rovalpituzumab Tesirine

Rovalpituzumab Tesirine is an antibody-drug conjugate (ADC) containing a humanized IgG1 monoclonal antibody (MAb) directed against the delta-like protein 3 (DLL3), conjugated to the cytotoxic pyrrolobenzodiazepine (PBD) dimer D6.5 (SC-DR002) via a maleimide-containing linker with an eight-carbon polyethylene glycol spacer and a cathepsin B-cleavable valine-alanine dipeptide, with potential antineoplastic activity. The MAb moiety of rovalpituzumab tesirine selectively binds to DLL3 on tumor cell surfaces. Upon internalization of the ADC, the dipeptide linker is cleaved and D6.5 is released. Then the imine groups of the PBD moiety bind to the N2 positions of guanines on opposite strands of DNA. This induces DNA strand breaks, inhibits DNA replication, leads to G2/M cell cycle arrest, induces cell death, and inhibits the proliferation of DLL3-overexpressing tumor cells. DLL3, a membrane protein that binds to Notch receptors and regulates Notch-mediated signaling and gene transcription, is overexpressed by certain cancers but is rarely expressed by normal, healthy cells.

Rovalpituzumab Tesirine Manufacturers

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

Rovalpituzumab Tesirine Suppliers

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

Rovalpituzumab Tesirine GMP

Rovalpituzumab Tesirine 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 Rovalpituzumab Tesirine 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 Rovalpituzumab Tesirine GMP manufacturer or Rovalpituzumab Tesirine GMP API supplier for your needs.

Rovalpituzumab Tesirine CoA

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

Rovalpituzumab Tesirine CoA mostly includes findings from lab analyses of a specific batch. For each Rovalpituzumab Tesirine 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.

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