01 1ABX Advanced Biochemical Compounds
02 1Novartis Pharmaceuticals Corporation
03 1piCHEM Forschungs- und Entwicklungs GmbH
01 1Austria
02 1Germany
03 1Switzerland
01 2Active
02 1Inactive
01 3Blank
01 3Blank
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36829
Submission : 2022-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35060
Submission : 2022-03-16
Status : Active
Type : II
NDC Package Code : 72775-540
Start Marketing Date : 2023-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21869
Submission : 2008-08-08
Status : Inactive
Type : II
A Edotreotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edotreotide, including repackagers and relabelers. The FDA regulates Edotreotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edotreotide 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 Edotreotide supplier is an individual or a company that provides Edotreotide active pharmaceutical ingredient (API) or Edotreotide finished formulations upon request. The Edotreotide suppliers may include Edotreotide API manufacturers, exporters, distributors and traders.
click here to find a list of Edotreotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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