01 1Sunny Biotech
02 1Zhejiang Shenghua Biok Biology
01 2PLEUROMUTILIN
01 2China
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33283
Submission : 2018-10-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21721
Submission : 2008-06-18
Status : Active
Type : II
A Pleuromutilin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pleuromutilin, including repackagers and relabelers. The FDA regulates Pleuromutilin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pleuromutilin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Pleuromutilin supplier is an individual or a company that provides Pleuromutilin active pharmaceutical ingredient (API) or Pleuromutilin finished formulations upon request. The Pleuromutilin suppliers may include Pleuromutilin API manufacturers, exporters, distributors and traders.
click here to find a list of Pleuromutilin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pleuromutilin DMF (Drug Master File) is a document detailing the whole manufacturing process of Pleuromutilin active pharmaceutical ingredient (API) in detail. Different forms of Pleuromutilin DMFs exist exist since differing nations have different regulations, such as Pleuromutilin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pleuromutilin DMF submitted to regulatory agencies in the US is known as a USDMF. Pleuromutilin USDMF includes data on Pleuromutilin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pleuromutilin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pleuromutilin suppliers with USDMF on PharmaCompass.
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