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 Mucosil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mucosil, including repackagers and relabelers. The FDA regulates Mucosil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mucosil 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 Mucosil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mucosil supplier is an individual or a company that provides Mucosil active pharmaceutical ingredient (API) or Mucosil finished formulations upon request. The Mucosil suppliers may include Mucosil API manufacturers, exporters, distributors and traders.
click here to find a list of Mucosil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mucosil DMF (Drug Master File) is a document detailing the whole manufacturing process of Mucosil active pharmaceutical ingredient (API) in detail. Different forms of Mucosil DMFs exist exist since differing nations have different regulations, such as Mucosil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mucosil DMF submitted to regulatory agencies in the US is known as a USDMF. Mucosil USDMF includes data on Mucosil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mucosil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mucosil suppliers with USDMF on PharmaCompass.
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