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