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