Minakem is manufacturing small molecules APIs including corticosteroids
01 1Minakem (formerly Delmar Chemicals)
02 1Mankind Pharma
03 1Abbott Laboratories
04 1Amoli Organics
05 1Harman Finochem
06 1Mac-Chem Products (India) Pvt.Ltd
07 1Nycomed Austria GmbH
08 1Phlow Corporation
09 1Solara Active Pharma Sciences
10 1Xian Libang Pharmaceutical Co.,Ltd
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-02
Pay. Date : 2018-02-12
DMF Number : 23224
Submission : 2009-10-29
Status :
Type : II
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-29
Pay. Date : 2022-08-18
DMF Number : 37245
Submission : 2022-07-25
Status :
Type : II
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A Midarine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Midarine, including repackagers and relabelers. The FDA regulates Midarine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Midarine 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 Midarine supplier is an individual or a company that provides Midarine active pharmaceutical ingredient (API) or Midarine finished formulations upon request. The Midarine suppliers may include Midarine API manufacturers, exporters, distributors and traders.
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A Midarine DMF (Drug Master File) is a document detailing the whole manufacturing process of Midarine active pharmaceutical ingredient (API) in detail. Different forms of Midarine DMFs exist exist since differing nations have different regulations, such as Midarine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Midarine DMF submitted to regulatory agencies in the US is known as a USDMF. Midarine USDMF includes data on Midarine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Midarine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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