01 1SIGMA TAU
02 1Sigma-Aldrich Corporation
01 1L-ORNITHINE HCL
02 1POLY-L-ORNITHINE HYDROCHLORIDE
01 2U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4729
Submission : 1982-12-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35111
Submission : 2021-01-08
Status : Active
Type : II
A DL-Ornithine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DL-Ornithine hydrochloride, including repackagers and relabelers. The FDA regulates DL-Ornithine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DL-Ornithine 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-Ornithine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DL-Ornithine hydrochloride supplier is an individual or a company that provides DL-Ornithine hydrochloride active pharmaceutical ingredient (API) or DL-Ornithine hydrochloride finished formulations upon request. The DL-Ornithine hydrochloride suppliers may include DL-Ornithine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of DL-Ornithine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DL-Ornithine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of DL-Ornithine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of DL-Ornithine hydrochloride DMFs exist exist since differing nations have different regulations, such as DL-Ornithine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DL-Ornithine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. DL-Ornithine hydrochloride USDMF includes data on DL-Ornithine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DL-Ornithine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DL-Ornithine hydrochloride suppliers with USDMF on PharmaCompass.
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