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01 1Cambridge Isotope Laboratories
02 1piCHEM Forschungs- und Entwicklungs GmbH
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01 1Austria
02 1U.S.A
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01 1Active
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01 1306MF10140
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01 171934-0024
02 172775-001
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35625
Submission : 2022-10-21
Status : Active
Type : II
Registration Number : 306MF10140
Registrant's Address : Parkring 3, 8074 Raaba-Grambach, Austria
Initial Date of Registration : 2024-11-06
Latest Date of Registration :
NDC Package Code : 72775-001
Start Marketing Date : 2023-04-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71934-0024
Start Marketing Date : 2022-03-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
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A 177 Lu-Labeled Psma-617 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 177 Lu-Labeled Psma-617, including repackagers and relabelers. The FDA regulates 177 Lu-Labeled Psma-617 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 177 Lu-Labeled Psma-617 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A 177 Lu-Labeled Psma-617 supplier is an individual or a company that provides 177 Lu-Labeled Psma-617 active pharmaceutical ingredient (API) or 177 Lu-Labeled Psma-617 finished formulations upon request. The 177 Lu-Labeled Psma-617 suppliers may include 177 Lu-Labeled Psma-617 API manufacturers, exporters, distributors and traders.
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We have 2 companies offering 177 Lu-Labeled Psma-617
Get in contact with the supplier of your choice: