Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1Moehs Iberica
02 1Maithri Drugs
01 2MAVACAMTEN
01 1India
02 1Spain
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38462
Submission : 2023-06-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39772
Submission : 2024-03-29
Status : Active
Type : II
A Mavacamten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mavacamten, including repackagers and relabelers. The FDA regulates Mavacamten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mavacamten 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 Mavacamten manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mavacamten supplier is an individual or a company that provides Mavacamten active pharmaceutical ingredient (API) or Mavacamten finished formulations upon request. The Mavacamten suppliers may include Mavacamten API manufacturers, exporters, distributors and traders.
click here to find a list of Mavacamten suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mavacamten DMF (Drug Master File) is a document detailing the whole manufacturing process of Mavacamten active pharmaceutical ingredient (API) in detail. Different forms of Mavacamten DMFs exist exist since differing nations have different regulations, such as Mavacamten USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mavacamten DMF submitted to regulatory agencies in the US is known as a USDMF. Mavacamten USDMF includes data on Mavacamten's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mavacamten USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mavacamten suppliers with USDMF on PharmaCompass.
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