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