Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1Moehs Iberica
02 1Hubei Gedian Humanwell Pharmaceutical
03 1Shandong Anhong Pharmaceutical
04 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
01 4LASMIDITAN HEMISUCCINATE
01 3China
02 1Spain
01 4Active
01 2Complete
02 2Blank
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38222
Submission : 2023-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-05
Pay. Date : 2024-10-22
DMF Number : 40130
Submission : 2024-07-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-18
Pay. Date : 2023-06-08
DMF Number : 38429
Submission : 2023-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40059
Submission : 2024-09-05
Status : Active
Type : II
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A Lasmiditan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lasmiditan, including repackagers and relabelers. The FDA regulates Lasmiditan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lasmiditan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Lasmiditan supplier is an individual or a company that provides Lasmiditan active pharmaceutical ingredient (API) or Lasmiditan finished formulations upon request. The Lasmiditan suppliers may include Lasmiditan API manufacturers, exporters, distributors and traders.
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A Lasmiditan DMF (Drug Master File) is a document detailing the whole manufacturing process of Lasmiditan active pharmaceutical ingredient (API) in detail. Different forms of Lasmiditan DMFs exist exist since differing nations have different regulations, such as Lasmiditan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lasmiditan DMF submitted to regulatory agencies in the US is known as a USDMF. Lasmiditan USDMF includes data on Lasmiditan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lasmiditan USDMF is kept confidential to protect the manufacturer’s intellectual property.
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