01 1Hetero Drugs
01 1SAQUINAVIR MESYLATE, USP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25118
Submission : 2011-07-12
Status : Active
Type : II
A Saquinavir Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Saquinavir Mesylate, including repackagers and relabelers. The FDA regulates Saquinavir Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Saquinavir Mesylate 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 Saquinavir Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Saquinavir Mesylate supplier is an individual or a company that provides Saquinavir Mesylate active pharmaceutical ingredient (API) or Saquinavir Mesylate finished formulations upon request. The Saquinavir Mesylate suppliers may include Saquinavir Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Saquinavir Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Saquinavir Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Saquinavir Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Saquinavir Mesylate DMFs exist exist since differing nations have different regulations, such as Saquinavir Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Saquinavir Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Saquinavir Mesylate USDMF includes data on Saquinavir Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Saquinavir Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Saquinavir Mesylate suppliers with USDMF on PharmaCompass.
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