01 2Helsinn Advanced Synthesis
01 1ANAMORELIN HYDROCHLORIDE (API)
02 1ANAMORELIN HYDROCHLORIDE, 100 MG TABLETS
01 2Switzerland
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30961
Submission : 2016-11-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31120
Submission : 2016-11-16
Status : Active
Type : II
A Anamorelin HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anamorelin HCl, including repackagers and relabelers. The FDA regulates Anamorelin HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anamorelin HCl API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Anamorelin HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Anamorelin HCl supplier is an individual or a company that provides Anamorelin HCl active pharmaceutical ingredient (API) or Anamorelin HCl finished formulations upon request. The Anamorelin HCl suppliers may include Anamorelin HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Anamorelin HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Anamorelin HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Anamorelin HCl active pharmaceutical ingredient (API) in detail. Different forms of Anamorelin HCl DMFs exist exist since differing nations have different regulations, such as Anamorelin HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Anamorelin HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Anamorelin HCl USDMF includes data on Anamorelin HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Anamorelin HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Anamorelin HCl suppliers with USDMF on PharmaCompass.
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