01 1Chifeng Arker Pharmaceutical Technology Co. Ltd.
02 1HUNAN JIUDIAN PHARMACEUTICAL CO LTD
01 1DIRITHROMYCIN
02 1DIRITHROMYCIN USP, NON-STERILE DRUG SUBSTANCE
01 2China
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18393
Submission : 2005-05-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20584
Submission : 2007-04-30
Status : Active
Type : II
A Dirithromycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dirithromycin, including repackagers and relabelers. The FDA regulates Dirithromycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dirithromycin 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 Dirithromycin supplier is an individual or a company that provides Dirithromycin active pharmaceutical ingredient (API) or Dirithromycin finished formulations upon request. The Dirithromycin suppliers may include Dirithromycin API manufacturers, exporters, distributors and traders.
click here to find a list of Dirithromycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dirithromycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Dirithromycin active pharmaceutical ingredient (API) in detail. Different forms of Dirithromycin DMFs exist exist since differing nations have different regulations, such as Dirithromycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dirithromycin DMF submitted to regulatory agencies in the US is known as a USDMF. Dirithromycin USDMF includes data on Dirithromycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dirithromycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dirithromycin suppliers with USDMF on PharmaCompass.
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