Copper Cu 64 Dotatate

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

1 API Suppliers, 1 USDMF, 2 NDC API

DOSSIERs // Finished Dosage Formulations

1 Dossiers, 1 FDA Orange Book

PATENTS

3 US Patents, 2 US Exclusivities

List of Suppliers

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CURIUM US LLC

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64CU-DOTATATE

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URL Supplier Web Content

DMF Number

33473

Status

Active

Submission Date

2019-12-31

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

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Looking for 1426155-87-4 / Copper Cu-64 Dotatate API manufacturers, exporters & distributors?

PharmaCompass offers a list of Copper Cu-64 Dotatate 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 Copper Cu-64 Dotatate manufacturer or Copper Cu-64 Dotatate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Copper Cu-64 Dotatate manufacturer or Copper Cu-64 Dotatate supplier.

PharmaCompass also assists you with knowing the Copper Cu-64 Dotatate API Price utilized in the formulation of products. Copper Cu-64 Dotatate API Price is not always fixed or binding as the Copper Cu-64 Dotatate Price is obtained through a variety of data sources. The Copper Cu-64 Dotatate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Copper Cu-64 Dotatate

Synonyms

Copper cu 64 dotatate, Copper 64-dota-tate, N3858377kc, 1426155-87-4, Copper (64cu) oxodotreotide, Unii-n3858377kc

Cas Number

1426155-87-4

About Copper Cu-64 Dotatate

Copper Cu 64 Dotatate is a radioconjugate consisting of the somatostatin analog tyrosine-3-octreotate (Tyr3-octreotate or TATE) labeled, via the macrocyclic chelating agent 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetra-acetic acid (DOTA), with the positron emission tomography (PET) tracer copper Cu 64, which may be used to image somatostatin receptor (SSTR)-expressing neuroendocrine tumors (NETs) upon PET. Upon administration of copper Cu 64 Dotatate, the TATE moiety targets and binds to SSTRs, with a much higher affinity for type 2 SSTR, present on the cell membranes of many types of NETs. This allows for visualization of SSTR-positive tumor cells upon PET. SSTR subtypes have been shown to be present in large numbers on NETs and their metastases, while most other normal tissues express low levels of SSTR subtypes.

Copper Cu 64 Dotatate Manufacturers

A Copper Cu 64 Dotatate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copper Cu 64 Dotatate, including repackagers and relabelers. The FDA regulates Copper Cu 64 Dotatate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copper Cu 64 Dotatate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Copper Cu 64 Dotatate Suppliers

A Copper Cu 64 Dotatate supplier is an individual or a company that provides Copper Cu 64 Dotatate active pharmaceutical ingredient (API) or Copper Cu 64 Dotatate finished formulations upon request. The Copper Cu 64 Dotatate suppliers may include Copper Cu 64 Dotatate API manufacturers, exporters, distributors and traders.

click here to find a list of Copper Cu 64 Dotatate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Copper Cu 64 Dotatate USDMF

A Copper Cu 64 Dotatate DMF (Drug Master File) is a document detailing the whole manufacturing process of Copper Cu 64 Dotatate active pharmaceutical ingredient (API) in detail. Different forms of Copper Cu 64 Dotatate DMFs exist exist since differing nations have different regulations, such as Copper Cu 64 Dotatate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Copper Cu 64 Dotatate DMF submitted to regulatory agencies in the US is known as a USDMF. Copper Cu 64 Dotatate USDMF includes data on Copper Cu 64 Dotatate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Copper Cu 64 Dotatate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Copper Cu 64 Dotatate suppliers with USDMF on PharmaCompass.

Copper Cu 64 Dotatate Manufacturers | Traders | Suppliers

We have 1 companies offering Copper Cu 64 Dotatate

Get in contact with the supplier of your choice:

CURIUM US LLC

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.