01 1Macrocyclics
02 1Oranomed
01 1212Pb-DOTAMTATE DRUG PRODUCT
02 1DOTAMTATE DRUG SUBSTANCE
01 2U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35952
Submission : 2021-05-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35863
Submission : 2021-05-20
Status : Active
Type : II
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PharmaCompass offers a list of Alphamedix API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Alphamedix manufacturer or Alphamedix supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alphamedix manufacturer or Alphamedix supplier.
A Alphamedix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alphamedix, including repackagers and relabelers. The FDA regulates Alphamedix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alphamedix 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 Alphamedix supplier is an individual or a company that provides Alphamedix active pharmaceutical ingredient (API) or Alphamedix finished formulations upon request. The Alphamedix suppliers may include Alphamedix API manufacturers, exporters, distributors and traders.
click here to find a list of Alphamedix suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Alphamedix DMF (Drug Master File) is a document detailing the whole manufacturing process of Alphamedix active pharmaceutical ingredient (API) in detail. Different forms of Alphamedix DMFs exist exist since differing nations have different regulations, such as Alphamedix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alphamedix DMF submitted to regulatory agencies in the US is known as a USDMF. Alphamedix USDMF includes data on Alphamedix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alphamedix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alphamedix suppliers with USDMF on PharmaCompass.
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