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List of Drug Master Files (DMF) of Lutetium-177 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Isotope Technologies Munich (2)

02 Blank (1)

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01 LU-177 N.C.A. PRECURSOR RADIOPHARMACEUTICAL PRECURSOR SOLUTION (1)

02 LUTETIUM (177LU) SOLUTION FOR RADIOLABELING (1)

03 LUTETIUM-177 RADIOCHEMICAL SOLUTION [LU-177] (1)

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01 Germany (2)

02 Blank (1)

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01 Active (3)

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01 Complete (1)

02 Blank (2)

URL Supplier Web Content
35008
Active
2020-09-21
Complete
2023-06-23
2023-06-20
II
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URL Supplier Web Content
31540
Active
2017-11-01
N/A
II
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META ISOTOPE TECHNOLOGY LLC

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URL Supplier Web Content
32943
Active
2018-07-11
N/A
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Looking for 14265-75-9 / Lutetium-177 API manufacturers, exporters & distributors?

Lutetium-177 manufacturers, exporters & distributors 1

99

PharmaCompass offers a list of Lutetium-177 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 Lutetium-177 manufacturer or Lutetium-177 supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lutetium-177 manufacturer or Lutetium-177 supplier.

PharmaCompass also assists you with knowing the Lutetium-177 API Price utilized in the formulation of products. Lutetium-177 API Price is not always fixed or binding as the Lutetium-177 Price is obtained through a variety of data sources. The Lutetium-177 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Lutetium-177

Synonyms

Lutetium lu-177, 14265-75-9, 177lu, Lu 177, Lu-177, Lutetium lu 177

Cas Number

14265-75-9

Unique Ingredient Identifier (UNII)

BRH40Y9V1Q

Lutetium-177 Manufacturers

A Lutetium-177 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lutetium-177, including repackagers and relabelers. The FDA regulates Lutetium-177 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lutetium-177 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Lutetium-177 Suppliers

A Lutetium-177 supplier is an individual or a company that provides Lutetium-177 active pharmaceutical ingredient (API) or Lutetium-177 finished formulations upon request. The Lutetium-177 suppliers may include Lutetium-177 API manufacturers, exporters, distributors and traders.

click here to find a list of Lutetium-177 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Lutetium-177 USDMF

A Lutetium-177 DMF (Drug Master File) is a document detailing the whole manufacturing process of Lutetium-177 active pharmaceutical ingredient (API) in detail. Different forms of Lutetium-177 DMFs exist exist since differing nations have different regulations, such as Lutetium-177 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Lutetium-177 DMF submitted to regulatory agencies in the US is known as a USDMF. Lutetium-177 USDMF includes data on Lutetium-177's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lutetium-177 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Lutetium-177 suppliers with USDMF on PharmaCompass.

Lutetium-177 Manufacturers | Traders | Suppliers

Lutetium-177 Manufacturers, Traders, Suppliers 1
19

We have 1 companies offering Lutetium-177

Get in contact with the supplier of your choice:

  1. Isotope Technologies Munich
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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