01 1CSPC Pharmaceutical Group
02 1Calyx Chemicals & Pharmaceuticals Limited
03 1Zhejiang Guobang Pharmaceutical
01 3AZAERYTHROMYCIN
01 2China
02 1India
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33053
Submission : 2018-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33820
Submission : 2019-05-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27801
Submission : 2013-12-08
Status : Active
Type : II
A Azathramycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azathramycin, including repackagers and relabelers. The FDA regulates Azathramycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azathramycin 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 Azathramycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azathramycin supplier is an individual or a company that provides Azathramycin active pharmaceutical ingredient (API) or Azathramycin finished formulations upon request. The Azathramycin suppliers may include Azathramycin API manufacturers, exporters, distributors and traders.
click here to find a list of Azathramycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azathramycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Azathramycin active pharmaceutical ingredient (API) in detail. Different forms of Azathramycin DMFs exist exist since differing nations have different regulations, such as Azathramycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azathramycin DMF submitted to regulatory agencies in the US is known as a USDMF. Azathramycin USDMF includes data on Azathramycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azathramycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azathramycin suppliers with USDMF on PharmaCompass.
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