01 1S D Fine Chem Limited
01 1SODIUM HYDROXIDE PELLETS BP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28719
Submission : 2014-10-03
Status : Active
Type : IV
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A 05211_SIAL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 05211_SIAL, including repackagers and relabelers. The FDA regulates 05211_SIAL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 05211_SIAL 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 05211_SIAL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 05211_SIAL supplier is an individual or a company that provides 05211_SIAL active pharmaceutical ingredient (API) or 05211_SIAL finished formulations upon request. The 05211_SIAL suppliers may include 05211_SIAL API manufacturers, exporters, distributors and traders.
click here to find a list of 05211_SIAL suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A 05211_SIAL DMF (Drug Master File) is a document detailing the whole manufacturing process of 05211_SIAL active pharmaceutical ingredient (API) in detail. Different forms of 05211_SIAL DMFs exist exist since differing nations have different regulations, such as 05211_SIAL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 05211_SIAL DMF submitted to regulatory agencies in the US is known as a USDMF. 05211_SIAL USDMF includes data on 05211_SIAL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 05211_SIAL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 05211_SIAL suppliers with USDMF on PharmaCompass.
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