Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1Moehs Iberica
02 1Olpha
03 1Amsa Spa
04 1Cilag AG
05 1Magle Chemoswed
06 1Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd
07 1Blank
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-16
Pay. Date : 2014-05-13
DMF Number : 6924
Submission : 1987-04-08
Status :
Type : II
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-20
Pay. Date : 2012-11-27
DMF Number : 23528
Submission : 2010-02-11
Status :
Type : II
A Amantadine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amantadine, including repackagers and relabelers. The FDA regulates Amantadine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amantadine 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 Amantadine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amantadine supplier is an individual or a company that provides Amantadine active pharmaceutical ingredient (API) or Amantadine finished formulations upon request. The Amantadine suppliers may include Amantadine API manufacturers, exporters, distributors and traders.
click here to find a list of Amantadine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amantadine DMF (Drug Master File) is a document detailing the whole manufacturing process of Amantadine active pharmaceutical ingredient (API) in detail. Different forms of Amantadine DMFs exist exist since differing nations have different regulations, such as Amantadine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amantadine DMF submitted to regulatory agencies in the US is known as a USDMF. Amantadine USDMF includes data on Amantadine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amantadine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amantadine suppliers with USDMF on PharmaCompass.
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