01 1Santen Pharmaceutical
01 1CS-011 DRUG SUBSTANCE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14320
Submission : 1999-07-29
Status : Inactive
Type : II
A Rivoglitazone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rivoglitazone Hydrochloride, including repackagers and relabelers. The FDA regulates Rivoglitazone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rivoglitazone Hydrochloride 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 Rivoglitazone Hydrochloride supplier is an individual or a company that provides Rivoglitazone Hydrochloride active pharmaceutical ingredient (API) or Rivoglitazone Hydrochloride finished formulations upon request. The Rivoglitazone Hydrochloride suppliers may include Rivoglitazone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Rivoglitazone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rivoglitazone Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Rivoglitazone Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Rivoglitazone Hydrochloride DMFs exist exist since differing nations have different regulations, such as Rivoglitazone Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rivoglitazone Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Rivoglitazone Hydrochloride USDMF includes data on Rivoglitazone Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rivoglitazone Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rivoglitazone Hydrochloride suppliers with USDMF on PharmaCompass.
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