Close
4

Bora CDMO Bora CDMO

X

Find Copper Cu-64 Dotatate manufacturers, exporters & distributors on PharmaCompass

PharmaCompass
API SUPPLIERS
API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications

0

JDMFs Filed

JDMFs Filed

0

Other Certificates

Other Certificates

0

Other Suppliers

Other Suppliers

0

API REF. PRICE (USD / KG)

0

INTERMEDIATES

0

DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

Europe

Europe

0

Canada

Canada

0

Australia

Australia

0

South Africa

South Africa

0

Uploaded Dossiers

Uploaded Dossiers

0

GLOBAL SALES (USD Million)

U.S. Medicaid

0

Annual Reports

0

EXCIPIENTS

0

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

USFDA Exclusivities

DIGITAL CONTENT

Blog #PharmaFlow

0

News

0

REF STANDARD

EDQM

0

USP

0

JP

0

Other Listed Suppliers

0

SERVICES

0

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

Copper Cu-64 Dotatate manufacturers, exporters & distributors 1

15

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 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 Copper Cu 64 Dotatate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Copper Cu 64 Dotatate 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 Copper Cu 64 Dotatate 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 Copper Cu 64 Dotatate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Copper Cu 64 Dotatate NDC to their finished compounded human drug products, they may choose to do so.

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

Copper Cu 64 Dotatate GMP

Copper Cu 64 Dotatate 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 Copper Cu 64 Dotatate 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 Copper Cu 64 Dotatate GMP manufacturer or Copper Cu 64 Dotatate GMP API supplier for your needs.

Copper Cu 64 Dotatate CoA

A Copper Cu 64 Dotatate CoA (Certificate of Analysis) is a formal document that attests to Copper Cu 64 Dotatate's compliance with Copper Cu 64 Dotatate specifications and serves as a tool for batch-level quality control.

Copper Cu 64 Dotatate CoA mostly includes findings from lab analyses of a specific batch. For each Copper Cu 64 Dotatate 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.

Copper Cu 64 Dotatate may be tested according to a variety of international standards, such as European Pharmacopoeia (Copper Cu 64 Dotatate EP), Copper Cu 64 Dotatate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Copper Cu 64 Dotatate 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty
Post Enquiry
POST ENQUIRY