01 1SIGMA TAU
01 1L-CARNITINE HCl (FIRST RUN)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3691
Submission : 1980-01-10
Status : Inactive
Type : II
A L(-)-Carnitine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L(-)-Carnitine hydrochloride, including repackagers and relabelers. The FDA regulates L(-)-Carnitine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L(-)-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 L(-)-Carnitine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L(-)-Carnitine hydrochloride supplier is an individual or a company that provides L(-)-Carnitine hydrochloride active pharmaceutical ingredient (API) or L(-)-Carnitine hydrochloride finished formulations upon request. The L(-)-Carnitine hydrochloride suppliers may include L(-)-Carnitine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of L(-)-Carnitine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L(-)-Carnitine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of L(-)-Carnitine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of L(-)-Carnitine hydrochloride DMFs exist exist since differing nations have different regulations, such as L(-)-Carnitine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L(-)-Carnitine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. L(-)-Carnitine hydrochloride USDMF includes data on L(-)-Carnitine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L(-)-Carnitine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L(-)-Carnitine hydrochloride suppliers with USDMF on PharmaCompass.
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