Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Moehs Iberica
03 1CJ Haide Biotech
04 1F.I.S. Fabbrica Italiana Sintetici
05 1Fujian South Pharmaceutical
06 1Nippon Protein Co Ltd
07 1Nippon Rikagaku Yakuhin
08 1Waitaki Biosciences
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2013-04-03
DMF Number : 5836
Submission : 1985-03-29
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-22
Pay. Date : 2013-01-07
DMF Number : 14304
Submission : 1999-07-21
Status :
Type : II
A Acetylcysteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acetylcysteine, including repackagers and relabelers. The FDA regulates Acetylcysteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acetylcysteine 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 Acetylcysteine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acetylcysteine supplier is an individual or a company that provides Acetylcysteine active pharmaceutical ingredient (API) or Acetylcysteine finished formulations upon request. The Acetylcysteine suppliers may include Acetylcysteine API manufacturers, exporters, distributors and traders.
click here to find a list of Acetylcysteine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acetylcysteine DMF (Drug Master File) is a document detailing the whole manufacturing process of Acetylcysteine active pharmaceutical ingredient (API) in detail. Different forms of Acetylcysteine DMFs exist exist since differing nations have different regulations, such as Acetylcysteine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acetylcysteine DMF submitted to regulatory agencies in the US is known as a USDMF. Acetylcysteine USDMF includes data on Acetylcysteine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acetylcysteine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acetylcysteine suppliers with USDMF on PharmaCompass.
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