Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
01 1Porton Pharma Solutions
02 1Arene Lifesciences
03 1Chromo Laboratories
04 1Cipla
05 2Hetero Drugs
06 1Laurus Labs
07 2Lupin Ltd
08 2MSN Laboratories
09 1Micro Labs Limited
10 1Viatris
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33798
Submission : 2019-04-22
Status :
Type : II
A Darunavir Ethanolate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Darunavir Ethanolate, including repackagers and relabelers. The FDA regulates Darunavir Ethanolate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Darunavir Ethanolate 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 Darunavir Ethanolate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Darunavir Ethanolate supplier is an individual or a company that provides Darunavir Ethanolate active pharmaceutical ingredient (API) or Darunavir Ethanolate finished formulations upon request. The Darunavir Ethanolate suppliers may include Darunavir Ethanolate API manufacturers, exporters, distributors and traders.
click here to find a list of Darunavir Ethanolate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Darunavir Ethanolate DMF (Drug Master File) is a document detailing the whole manufacturing process of Darunavir Ethanolate active pharmaceutical ingredient (API) in detail. Different forms of Darunavir Ethanolate DMFs exist exist since differing nations have different regulations, such as Darunavir Ethanolate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Darunavir Ethanolate DMF submitted to regulatory agencies in the US is known as a USDMF. Darunavir Ethanolate USDMF includes data on Darunavir Ethanolate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Darunavir Ethanolate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Darunavir Ethanolate suppliers with USDMF on PharmaCompass.
We have 10 companies offering Darunavir Ethanolate
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