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01 1Chifeng Arker Pharmaceutical Technology Co. Ltd.
02 1HUNAN JIUDIAN PHARMACEUTICAL CO LTD
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01 1DIRITHROMYCIN
02 1DIRITHROMYCIN USP, NON-STERILE DRUG SUBSTANCE
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01 2China
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01 1Active
02 1Inactive
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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
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PharmaCompass offers a list of Dirithromycin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dirithromycin manufacturer or Dirithromycin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dirithromycin manufacturer or Dirithromycin supplier.
PharmaCompass also assists you with knowing the Dirithromycin API Price utilized in the formulation of products. Dirithromycin API Price is not always fixed or binding as the Dirithromycin Price is obtained through a variety of data sources. The Dirithromycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dynabac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dynabac, including repackagers and relabelers. The FDA regulates Dynabac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dynabac 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 Dynabac supplier is an individual or a company that provides Dynabac active pharmaceutical ingredient (API) or Dynabac finished formulations upon request. The Dynabac suppliers may include Dynabac API manufacturers, exporters, distributors and traders.
click here to find a list of Dynabac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dynabac DMF (Drug Master File) is a document detailing the whole manufacturing process of Dynabac active pharmaceutical ingredient (API) in detail. Different forms of Dynabac DMFs exist exist since differing nations have different regulations, such as Dynabac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dynabac DMF submitted to regulatory agencies in the US is known as a USDMF. Dynabac USDMF includes data on Dynabac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dynabac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dynabac suppliers with USDMF on PharmaCompass.
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