Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1Moehs Iberica
01 1FEZOLINETANT
01 1Spain
01 1Active
01 1Blank
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40592
Submission : 2024-09-27
Status : Active
Type : II
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A ESN-364 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ESN-364, including repackagers and relabelers. The FDA regulates ESN-364 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ESN-364 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 ESN-364 supplier is an individual or a company that provides ESN-364 active pharmaceutical ingredient (API) or ESN-364 finished formulations upon request. The ESN-364 suppliers may include ESN-364 API manufacturers, exporters, distributors and traders.
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A ESN-364 DMF (Drug Master File) is a document detailing the whole manufacturing process of ESN-364 active pharmaceutical ingredient (API) in detail. Different forms of ESN-364 DMFs exist exist since differing nations have different regulations, such as ESN-364 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ESN-364 DMF submitted to regulatory agencies in the US is known as a USDMF. ESN-364 USDMF includes data on ESN-364's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ESN-364 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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