01 1Themis Medicare
01 1SIMVASTATIN AMMONIUM SALT
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39867
Submission : 2024-04-18
Status : Active
Type : II
A Mls006010119 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mls006010119, including repackagers and relabelers. The FDA regulates Mls006010119 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mls006010119 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Mls006010119 supplier is an individual or a company that provides Mls006010119 active pharmaceutical ingredient (API) or Mls006010119 finished formulations upon request. The Mls006010119 suppliers may include Mls006010119 API manufacturers, exporters, distributors and traders.
click here to find a list of Mls006010119 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mls006010119 DMF (Drug Master File) is a document detailing the whole manufacturing process of Mls006010119 active pharmaceutical ingredient (API) in detail. Different forms of Mls006010119 DMFs exist exist since differing nations have different regulations, such as Mls006010119 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mls006010119 DMF submitted to regulatory agencies in the US is known as a USDMF. Mls006010119 USDMF includes data on Mls006010119's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mls006010119 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mls006010119 suppliers with USDMF on PharmaCompass.
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