01 1SMS Pharmaceuticals
01 1IMIDAPRIL HYDROCHLORIDE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22705
Submission : 2009-04-07
Status : Active
Type : II
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A Tanatril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tanatril, including repackagers and relabelers. The FDA regulates Tanatril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tanatril 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 Tanatril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Tanatril supplier is an individual or a company that provides Tanatril active pharmaceutical ingredient (API) or Tanatril finished formulations upon request. The Tanatril suppliers may include Tanatril API manufacturers, exporters, distributors and traders.
click here to find a list of Tanatril suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Tanatril DMF (Drug Master File) is a document detailing the whole manufacturing process of Tanatril active pharmaceutical ingredient (API) in detail. Different forms of Tanatril DMFs exist exist since differing nations have different regulations, such as Tanatril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tanatril DMF submitted to regulatory agencies in the US is known as a USDMF. Tanatril USDMF includes data on Tanatril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tanatril USDMF is kept confidential to protect the manufacturer’s intellectual property.
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