01 1S D Fine Chem Limited
01 1ISOPROPYL ALCOHOL USP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28715
Submission : 2014-10-03
Status : Active
Type : IV
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A Spectrar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spectrar, including repackagers and relabelers. The FDA regulates Spectrar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spectrar 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 Spectrar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Spectrar supplier is an individual or a company that provides Spectrar active pharmaceutical ingredient (API) or Spectrar finished formulations upon request. The Spectrar suppliers may include Spectrar API manufacturers, exporters, distributors and traders.
click here to find a list of Spectrar suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Spectrar DMF (Drug Master File) is a document detailing the whole manufacturing process of Spectrar active pharmaceutical ingredient (API) in detail. Different forms of Spectrar DMFs exist exist since differing nations have different regulations, such as Spectrar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Spectrar DMF submitted to regulatory agencies in the US is known as a USDMF. Spectrar USDMF includes data on Spectrar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Spectrar USDMF is kept confidential to protect the manufacturer’s intellectual property.
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