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
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A Amantadine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amantadine HCl, including repackagers and relabelers. The FDA regulates Amantadine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amantadine HCl 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 Amantadine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Amantadine HCl active pharmaceutical ingredient (API) in detail. Different forms of Amantadine HCl DMFs exist exist since differing nations have different regulations, such as Amantadine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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