01 1Mitsubishi Tanabe Pharma
01 1DL-CARNITINE HYDROCHLORIDE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 523
Submission : 1963-03-19
Status : Inactive
Type : II
A Dl-Carnitine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dl-Carnitine Hydrochloride, including repackagers and relabelers. The FDA regulates Dl-Carnitine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dl-Carnitine 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.
click here to find a list of Dl-Carnitine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dl-Carnitine Hydrochloride supplier is an individual or a company that provides Dl-Carnitine Hydrochloride active pharmaceutical ingredient (API) or Dl-Carnitine Hydrochloride finished formulations upon request. The Dl-Carnitine Hydrochloride suppliers may include Dl-Carnitine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dl-Carnitine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dl-Carnitine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dl-Carnitine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dl-Carnitine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dl-Carnitine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dl-Carnitine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dl-Carnitine Hydrochloride USDMF includes data on Dl-Carnitine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dl-Carnitine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dl-Carnitine Hydrochloride suppliers with USDMF on PharmaCompass.
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