01 1Calyx Chemicals & Pharmaceuticals Limited
02 1Cipla
03 1Ipca Laboratories
04 1Micro Labs Limited
05 1Solara Active Pharma Sciences
06 1Vital Laboratories Private Limited
01 6ARTEMETHER
01 6India
01 4Active
02 2Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23968
Submission : 2010-07-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20187
Submission : 2008-04-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22217
Submission : 2009-02-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27933
Submission : 2014-02-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22995
Submission : 2009-07-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25306
Submission : 2011-06-09
Status : Active
Type : II
A Artemether manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Artemether, including repackagers and relabelers. The FDA regulates Artemether manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Artemether 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 Artemether manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Artemether supplier is an individual or a company that provides Artemether active pharmaceutical ingredient (API) or Artemether finished formulations upon request. The Artemether suppliers may include Artemether API manufacturers, exporters, distributors and traders.
click here to find a list of Artemether suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Artemether DMF (Drug Master File) is a document detailing the whole manufacturing process of Artemether active pharmaceutical ingredient (API) in detail. Different forms of Artemether DMFs exist exist since differing nations have different regulations, such as Artemether USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Artemether DMF submitted to regulatory agencies in the US is known as a USDMF. Artemether USDMF includes data on Artemether's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Artemether USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Artemether suppliers with USDMF on PharmaCompass.
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