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