01 1Viatris
01 1ROSIGLITAZONE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23927
Submission : 2010-06-29
Status : Inactive
Type : II
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A Rosix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rosix, including repackagers and relabelers. The FDA regulates Rosix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rosix 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 Rosix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Rosix supplier is an individual or a company that provides Rosix active pharmaceutical ingredient (API) or Rosix finished formulations upon request. The Rosix suppliers may include Rosix API manufacturers, exporters, distributors and traders.
click here to find a list of Rosix suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Rosix DMF (Drug Master File) is a document detailing the whole manufacturing process of Rosix active pharmaceutical ingredient (API) in detail. Different forms of Rosix DMFs exist exist since differing nations have different regulations, such as Rosix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rosix DMF submitted to regulatory agencies in the US is known as a USDMF. Rosix USDMF includes data on Rosix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rosix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rosix suppliers with USDMF on PharmaCompass.
