01 1FDC
01 1CINNARIZINE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31934
Submission : 2017-09-07
Status : Active
Type : II
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A Eglen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eglen, including repackagers and relabelers. The FDA regulates Eglen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eglen 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 Eglen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Eglen supplier is an individual or a company that provides Eglen active pharmaceutical ingredient (API) or Eglen finished formulations upon request. The Eglen suppliers may include Eglen API manufacturers, exporters, distributors and traders.
click here to find a list of Eglen suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Eglen DMF (Drug Master File) is a document detailing the whole manufacturing process of Eglen active pharmaceutical ingredient (API) in detail. Different forms of Eglen DMFs exist exist since differing nations have different regulations, such as Eglen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eglen DMF submitted to regulatory agencies in the US is known as a USDMF. Eglen USDMF includes data on Eglen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eglen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eglen suppliers with USDMF on PharmaCompass.
