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